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Background: Pain and anxiety management in patients undergoing medical and surgical procedures is an important competence area for nurses. Aim: This study aimed to determine and compare the effects of virtual reality and acupressure interventions on pain, anxiety, vital signs and comfort levels in the process of femoral catheter extraction for patients undergoing coronary angiography. Methods: The study was a single‐blind, three‐group, randomized controlled trial conducted in the cardiology clinics of a university hospital in 2021. A total of 153 patients (51 virtual reality, 51 acupressure, 51 control) participated in the study. Data were collected using a Visual Analogue Scale, the State–Trait Anxiety Inventory, a vital signs follow‐up form and the Perianesthesia Comfort Scale. Results: Both intervention groups had significantly lower pain and anxiety scores, as well as higher comfort scores, compared to the control group (p < 0.001). The virtual reality group had lower systolic blood pressure, respiratory rate and pulse rate than the control group (p < 0.05). The acupressure group had lower systolic and diastolic blood pressure and respiratory rate than the control group (p < 0.05). Conclusions: While neither intervention group was found to be superior to the other, both interventions improved vital signs and comfort levels by reducing pain and anxiety. Summary statement: What is already known about this topic? Uncontrolled pain and anxiety during medical and surgical procedures may increase the risk of complications and have negative effects on the pulmonary and cardiovascular systems, leading to changes in vital signs and compromising patients' hemodynamics.Virtual reality has demonstrated its potential to restore cognitive attention capacities, enabling patients to remain engaged and mentally focused during procedures, and thus reducing pain and anxiety.Acupressure, as a non‐pharmacological intervention, involves applying pressure to specific points on the body to alleviate pain and anxiety. It constitutes a safe, side‐effect‐free and cost‐effective option for improving patient outcomes.What this paper adds? This paper contributes to the knowledge of virtual reality and acupressure interventions as non‐pharmacological approaches that nurses can safely incorporate within their independent professional roles.The study evaluates the effects of traditional acupressure and technological virtual reality interventions on patients, comparing the two interventions for the first time to the best of our knowledge. Furthermore, to the best of our knowledge, these procedures were applied for the first time in femoral catheter extraction after coronary angiography.The implications of this paper: This study emphasizes the positive impacts of virtual reality and acupressure interventions administered by nurses for patients undergoing medical procedures.Overall, the findings suggest that non‐pharmacological techniques such as virtual reality and acupressure can contribute to a similar degree in improving patient outcomes during medical procedures. [ABSTRACT FROM AUTHOR]

Aims: The present study aimed to explore the effects of a guided self‐help mindfulness intervention on psychological resilience and job burnout among psychiatric nurses. Background: Psychiatric nurses work in challenging and potentially high stress settings. Mindfulness interventions can improve psychological resilience and reduce job burnout of nurses. However, face‐to‐face delivery of mindfulness interventions may be inconvenient for individuals. Guided self‐help interventions may be more accessible. Methods: This randomized controlled trial was conducted from January to August 2022. One hundred and eighteen psychiatric nurses were randomized into the intervention and control groups. The individuals in the intervention group received an 8‐week guided self‐help mindfulness intervention, while the individuals in the control group received a psycho‐educational brochure. The Five Facet Mindfulness Questionnaire, the Connor‐Davidson Resilience Scale and the Maslach Burnout Inventory‐Human Services Survey were used to evaluate the levels of mindfulness, psychological resilience and job burnout, respectively. Results: After an 8‐week intervention, compared with the control group, the levels of mindfulness and psychological resilience were higher, while the level of job burnout was lower in the intervention group. Conclusions: The guided self‐help mindfulness intervention can improve psychological resilience and reduce job burnout among psychiatric nurses. Summary statement: What is already known about the topic? Mindfulness‐based interventions can improve psychological resilience and reduce job burnout of nurses.A growing body of studies has begun incorporating self‐help strategies with mindfulness‐based interventions.There are few studies exploring the use of the guided self‐help mindfulness interventions for Chinese psychiatric nurses and the associated effects on psychological resilience and job burnout. What this paper adds? The guided self‐help mindfulness intervention reduced job burnout and improved psychological resilience compared with psycho‐education intervention. Implications of this research Self‐guided mindfulness interventions can be used to improve psychological resilience and reduce job burnout among psychiatric nurses.In the future, the impact of self‐help mindfulness interventions on the mental health of nurses in other specialties can be trialled. [ABSTRACT FROM AUTHOR]

Background: Decisions regarding maintenance therapy in patients with multiple myeloma should be based on both treatment efficacy and health-related quality of life (HRQL) consequences. In the CARFI trial, patients with first relapse of multiple myeloma underwent salvage autologous stem cell transplantation (salvage ASCT) before randomization to carfilzomib-dexamethasone maintenance therapy (Kd) or observation. The primary clinical endpoint was time to progression, which was extended by 8 months by Kd. The aim of this paper is to present the all HRQL endpoints of the CARFI trial including the HRQL effect of Kd maintenance therapy relative to observation. The primary HRQL endpoint was assessed by EORTC QLQ-C30 Summary score (QLQ-C30-sum) at 8 months follow-up. A key secondary HRQL endpoint was quality-adjusted progression-free-survival (QAPFS). Methods: HRQL was assessed with EORTC QLQ-C30, EORTC QLQ-MY20 and FACT/GOG-Ntx at randomization and every second month during follow-up. HRQL data were analyzed with linear mixed effect models until 8 months follow-up. QAPFS per individual was calculated by multiplying progression-free survival (PFS) by two quality-adjustment metrics, the QLQ-C30-sum and EORTC Quality of Life Utility Measure-Core 10 dimensions (QLU-C10D). The QAPFS per treatment group was estimated with the Kaplan-Meier method. P < 0.05 was used for statistical significance, and a between-group minimal important difference of 10 points was interpreted as clinically relevant for the QLQ-C30-sum. Results: 168 patients were randomized. HRQL questionnaire compliance was 93%. For the QLQ-C30-sum, the difference of 4.62 points (95% confidence interval (CI) -8.9: -0.4, p = 0.032) was not clinically relevant. PFS was 19.3 months for the Kd maintenance group and 16.8 months for the observation group; difference = 2.5 months (95% CI 0.5; 4.5). QAPFS based on the QLQ-C30-sum for the Kd maintenance group was 18.0 months (95% CI 16.4; 19.6) and for the observation group 15.0 months (95% CI 13.5; 16.5); difference = 3.0 months (95% CI 0.8–5.3). QAPFS based on the QLU-C10D for the Kd maintenance group was 17.5 months (95% CI 15.9; 19.2) and 14.0 months (95% CI 12.4; 15.5) for the observation group; difference = 3.5 months (95% CI 1.1–5.9). Conclusions: Kd maintenance therapy after salvage ASCT did not adversely affect overall HRQL, but adjustment for HRQL reduced the PFS compared to unadjusted PFS. PFS of maintenance therapy should be quality-adjusted to balance the benefits and HRQL impact. [ABSTRACT FROM AUTHOR]

Background: A total of 68% of pre‐school children with cleft palate have speech problems requiring speech therapy. There is a lack of access to regular targeted therapy. Parent training leads to positive outcomes in early communication skills in cleft palate and non‐cleft speech disorders. Connected health has been used to address inadequate access to therapy, providing intervention to those who would not otherwise receive therapy. Aims: To evaluate the speech, activity and participation outcomes of Parent Led, Therapist Supervised, Articulation Therapy (PLAT) compared with routine speech therapy intervention in parent–child dyads. Methods & Procedures: A total of 44 children, aged 2.9–7.5 years, were included in a two‐centre, two‐phase randomized controlled trial. Informed consent and assent were obtained. Participants and speech and language therapists (SLTs) were unblinded to the groups. Parents, in the parent‐trained group (n = 23), attended 2 days' training, received a detailed speech therapy programme, and undertook intervention over 12 weeks supported by the cleft specialist SLT using FaceTime and one face‐to‐face session. In the control arm (n = 21), parent–child dyads received six therapy sessions over 12 weeks with a research SLT, comparable with usual care. Speech recordings were undertaken pre‐ and post‐intervention. Percent consonant correct (PCC) was analysed by external SLTs blinded to the time and group. Activity and participation were measured using the Intelligibility in Context Scale (ICS) and Focus on Outcomes for Children Under Six (FOCUS) questionnaire. Outcomes & Results: There was no evidence of an interaction between Time and Group or an overall statistical difference between groups for PCC scores. There was a statistically significant difference over time for both groups (words: p < 0.002; confidence interval (CI) = 9.38–16.27; d = 0.57; sentences: p < 0.002; CI = 16.04–25.97; d = 0.23). Effect sizes were medium for words and small for sentences. For intelligibility and participation, there was no evidence of an interaction between Time and Group or an overall statistical difference between groups. A statistically significant difference over time was found for intelligibility (F = 29.97, d.f. = 1, 42, p < 0.001, 95 % CI = 1.45–3.15 d = 0.46) and for participation (F = 14.19, d.f. = 1, 41, p < 0.001 95% CI = 7.63–25.03; d = 0.36) with FOCUS results indicating clinically meaningful (parent‐led group) and significant (control group) change in participation. Conclusions & Implications: PLAT can be as effective as routine care in changing speech, activity and participation outcomes for children with cleft palate, when supported by a specialist cleft SLT using connected health. What this paper addsWhat is already known on this subjectOver 50% of children with cleft palate require speech therapy. However, there is a lack of timely, accessible speech therapy services in the UK and Ireland. Previous studies have shown that parents can deliver therapy effectively, and that connected health can support the delivery of speech therapy. This study aims to provide evidence that parent‐led therapy with the supervision of a specialist cleft therapist using FaceTime is effective.What this paper adds to existing knowledgeThis randomized controlled trial indicates that parents can be trained to deliver therapy for children with cleft palate speech disorders, under the supervision of an SLT. This approach results in improved speech, activity and participation outcomes similar to routine care.What are the potential or actual clinical implications of this work?This study indicates that both parent‐led articulation therapy and routine care showed meaningful gains in speech, activity and participation, and that parent‐led articulation therapy when supported by a cleft SLT using connected health could be an additional service delivery model for children with cleft palate speech disorders. [ABSTRACT FROM AUTHOR]

Introduction. The primary aim of this study was to provide a comparison of the effects of 2 commonly used pedagogical approaches (paper-based case studies vs authentic patient experiences) on clinical reasoning and critical thinking of secondyear entry-level physical therapy students. Current literature reveals a lack of consistency in how clinical reasoning is taught and assessed in physical therapist education. There is a need for evidence-based approaches to develop clinical reasoning in entry-level physical therapy students in the United States. Subjects. Twenty-three students in their second year of a Doctor of Physical therapy (DPT) degree program participated in this study. Methods. Participants were randomly assigned to a control group or to receive 1 of 2 supplemental learning activities (paper-based case studies or authentic patient experiences). Outcomes measured preintervention and postintervention included the Health Science Reasoning Test with Numeracy (HSRT-N) and the Self- Assessment of Clinical Reasoning and Re- flection (SACRR). Data analysis included a comparison of effect sizes of change scores between groups and correlational analysis of pretest scores and student factors. Results. Authentic patient experiences demonstrated a moderate to large effect size for improved HSRT-N scores on 5 of 8 subscales, compared with paper-based case studies. Authentic patient experiences demonstrated a moderate effect size for improved SACRR scores compared with the control group. Discussion and Conclusion. The use of authentic patient experiences may be more effective than paper-based case studies for improving critical thinking and clinical reasoning in an entry-level DPT curriculum. [ABSTRACT FROM AUTHOR]

Objective: To investigate the effects of combining a Pilates program with photobiomodulation therapy (PBMT) in patients with chronic nonspecific low back pain (CNLBP). Methods: Thirty-eight adults with CNLBP were randomly assigned to two groups: Pilates exercise + active PBMT (PIL + PBMT) or Pilates exercise + sham PBMT (PIL + SHAM). Both groups performed an 8-week mat Pilates program and received PBMT on their lumbar muscles 10 min before and after each session. The following variables were assessed before and after intervention: peak pain intensity, postural balance (i.e., center of the pressure [A-COP], velocity anteroposterior [Vel AP], and velocity mediolateral [Vel ML]), perceived disability (i.e., Oswestry Disability Index [ODI] and Roland Morris Disability Questionnaire [RMDQ]), and pain-related fear of movement (i.e., Tampa Scale of Kinesiophobia [TSK], Fear Avoidance Beliefs Questionnaire [FABQ], and Pain Catastrophizing Scale [PCS]). Results: Postural balance variables showed no statistically significant differences (p > 0.05) across time or between groups. The groups showed similar (p < 0.05) reductions in peak pain intensity, ODI, RMDQ, and PCS scores, but no statistically significant difference (p > 0.05) in TSK and FABQ scores. Conclusion: The mat Pilates program reduced peak pain intensity, perceived disability, and pain catastrophizing in adults with CNLBP, but PBMT had no additional effect on these variables. Mat Pilates alone or combined with PBMT was not able to improve postural balance. [ABSTRACT FROM AUTHOR]

Context: Cross-education (CE) refers to neuromuscular gains in the untrained limb upon contralateral limb training. To date, only laboratory-based exercise programs have demonstrated CE. Home-based exercise prescription eliciting CE could have greater clinical applicability. Objective: To determine the effect of an 8-week, home-based unilateral strength training intervention on isokinetic muscle strength, muscular excitation, and power in trained and untrained plantar flexors. Design: Randomized controlled trial. Methods: Thirty-four healthy participants were randomized to intervention (n = 20) or control (n = 14). The intervention group completed 3 sets of 12 repetitions of progressively loaded unilateral calf raises 3 days per week. Concentric and eccentric peak torque were measured using isokinetic dynamometry at 30°/s and 120°/s. Maximal electromyogram amplitude was simultaneously measured. Power was measured using a jump mat. All variables were measured at preintervention, midintervention, and postintervention. Results: Strength significantly increased bilaterally pre–post at both velocities concentrically and eccentrically in intervention group participants. Maximal electromyogram amplitude significantly increased pre–post bilaterally at both velocities in the medial gastrocnemii of the intervention group. Power significantly increased bilaterally pre–post in the intervention group, with a dose–response effect demonstrated in the untrained plantar flexors. The CE effects of strength, power, and electromyogram activation were 23.4%, 14.6%, and 25.3%, respectively. All control group values were unchanged pre–post. Conclusion: This study shows that a simple at-home unilateral plantar flexor exercise protocol induces significant increases in contralateral strength, muscular excitation, and power. These results suggest the applicability of CE in home rehabilitation programs aiming to restore or maintain neuromuscular function in inactive individuals or immobilized ankles. [ABSTRACT FROM AUTHOR]

Network meta-analysis expands the scope of a conventional pairwise meta-analysis to simultaneously compare multiple treatments, synthesizing both direct and indirect information and thus strengthening inference. Since most of trials only compare two treatments, a typical data set in a network meta-analysis managed as a trial-by-treatment matrix is extremely sparse, like an incomplete block structure with significant missing data. Zhang et al. proposed an arm-based method accounting for correlations among different treatments within the same trial and assuming that absent arms are missing at random. However, in randomized controlled trials, nonignorable missingness or missingness not at random may occur due to deliberate choices of treatments at the design stage. In addition, those undertaking a network meta-analysis may selectively choose treatments to include in the analysis, which may also lead to missingness not at random. In this paper, we extend our previous work to incorporate missingness not at random using selection models. The proposed method is then applied to two network meta-analyses and evaluated through extensive simulation studies. We also provide comprehensive comparisons of a commonly used contrast-based method and the arm-based method via simulations in a technical appendix under missing completely at random and missing at random. [ABSTRACT FROM AUTHOR]

Mobilization with movement (MWM) and myofascial release (MFR) are treatment techniques that increase ankle dorsiflexion range of motion (DFROM). Manual lymphatic drainage (MLD) facilitates waste drainage and improves soft tissue tension in peripheral tissues. To date, no studies have investigated how the combination of MLD, MWM, and MFR influences the human body. The purpose of this study is to determine how the combination of MLD, MWM, and MFR affects DFROM and balance ability. We randomly assigned 16 individuals (26 feet) to one of three groups: MWM-MFR (MR), MWM-MLD (MD), or MWM-MFR-MLD (MRD) intervention. To confirm the intervention effect of each group, DFROM was assessed using a modified lunge test, and dynamic balance was measured using a modified star excursion balance test. In the results, differences were found between the MR and MRD groups in PL and mGCM activities in the 1 section (p = 0.008, p = 0.036) and between the MD and MRD groups in mGCM activity in the 4 and 5 sections (p = 0.049, p = 0.004). We suggest that the application of MRD is the most effective intervention for increasing muscle activation of the PL and mGCM during the modified star excursion balance test. [ABSTRACT FROM AUTHOR]

Background: Post-COVID-19 Condition (PCC), as defined by the World Health Organization (WHO), currently lacks any regulatory-approved treatments and is characterized by persistent and debilitating cognitive impairment and mood symptoms. Additionally, metabolic dysfunction, chronic inflammation and the associated risks of elevated body mass index (BMI) have been reported. In this study, we aim to investigate the efficacy of vortioxetine in improving cognitive deficits in individuals with PCC, accounting for the interaction of metabolic dysfunction, elevated inflammation and BMI. Methods: This is a post-hoc analysis of an 8-week randomized, double-blind, placebo-controlled trial that was conducted among adults aged 18 years and older living in Canada who were experiencing WHO-defined PCC symptoms. The recruitment of participants began in November 2021 and concluded in January 2023. A total of 200 individuals were enrolled, where 147 were randomized in a 1:1 ratio to receive either vortioxetine (5–20 mg, n = 73) or placebo (n = 74) for daily treatment under double-blind conditions. The primary outcome measure was the change in the Digit Symbol Substitution Test (DSST) score from baseline to endpoint. Results: Our findings showed significant effects for time (χ2 = 7.771, p = 0.005), treatment (χ2 = 7.583, p = 0.006) and the treatment x time x CRP x TG-HDL x BMI interaction (χ2 = 11.967, p = 0.018) on cognitive function. Moreover, the between-group analysis showed a significant improvement with vortioxetine at endpoint (mean difference = 0.621, SEM = 0.313, p = 0.047). Conclusion: Overall, vortioxetine demonstrated significant improvements in cognitive deficits among individuals with baseline markers of metabolic dysfunction, elevated inflammation and higher BMI at endpoint as compared to placebo. Trial Registration: NCT05047952 (ClinicalTrials.gov; Registration Date: September 17, 2021). [ABSTRACT FROM AUTHOR]

Photoactivated disinfection with sodium hypochlorite (NaOCl) has improved primary root canal treatment outcomes. This in vitro study aims to assess and compare the disinfecting efficacy of 2.5% sodium hypochlorite solution and 5.25% sodium hypochlorite gel, without laser activation and accompanied by laser activation, on Enterococcus faecalis-contaminated primary teeth root canals. After one month of incubating extracted teeth specimens with E. faecalis, 36 specimens were randomly divided into two groups: Group A (conventional method without laser-activated irrigation) and Group B (with laser-activated irrigation). Each group was further divided into three subgroups, with six samples in each subgroup. Subgroup 1 received irrigation with normal saline, Subgroup 2 with 2.5% sodium hypochlorite solution, and Subgroup 3 with 5.25% sodium hypochlorite gel. Diode laser activation at 810 nm was used in Group B. Bacterial colony counts were measured before and after the intervention. Student's t-test and one-way analysis of variance (ANOVA) with Tukey's post hoc test were used for statistical analysis. The significance level was set at p < 0.05. Microbial analysis revealed no bacterial growth in samples irrigated with 5.25% sodium hypochlorite gel activated with the laser. Activation with the laser significantly (p = 0.02) improved the disinfection ability of the irrigant compared to the non-activation group. The disinfection ability of sodium hypochlorite gel was better than that of saline (p = 0.02); however, it was comparable to that of sodium hypochlorite solution (p = 0.67). Conclusion: Root canal irrigation with 5.25% sodium hypochlorite gel activated with an 810 nm diode laser resulted in complete eradication of Enterococcus faecalis, indicating its effectiveness as an endodontic disinfection treatment modality. [ABSTRACT FROM AUTHOR]

Purpose: Patient-reported outcome measures (PROMs) are designed to assess patients' perceived health states or health-related quality of life. However, PROMs are susceptible to missing data, which can affect the validity of conclusions from randomised controlled trials (RCTs). This review aims to assess current practice in the handling, analysis and reporting of missing PROMs outcome data in RCTs compared to contemporary methodology and guidance. Methods: This structured review of the literature includes RCTs with a minimum of 50 participants per arm. Studies using the EQ-5D-3L, EORTC QLQ-C30, SF-12 and SF-36 were included if published in 2013; those using the less commonly implemented HUI, OHS, OKS and PDQ were included if published between 2009 and 2013. Results: The review included 237 records (4-76 per relevant PROM). Complete case analysis and single imputation were commonly used in 33 and 15 % of publications, respectively. Multiple imputation was reported for 9 % of the PROMs reviewed. The majority of publications (93 %) failed to describe the assumed missing data mechanism, while low numbers of papers reported methods to minimise missing data (23 %), performed sensitivity analyses (22 %) or discussed the potential influence of missing data on results (16 %). Conclusions: Considerable discrepancy exists between approved methodology and current practice in handling, analysis and reporting of missing PROMs outcome data in RCTs. Greater awareness is needed for the potential biases introduced by inappropriate handling of missing data, as well as the importance of sensitivity analysis and clear reporting to enable appropriate assessments of treatment effects and conclusions from RCTs. [ABSTRACT FROM AUTHOR]

While there is broad consensus about the need for interventions to help psychologically distressed, war ajfectedyouth, there is also limited research and even less agreement on which interventions work best. Therefore, this paper presents a randomised trial of trauma focused, and non trauma focused, interventions with war affected Congolese youth. Fifty war affected Congolese youth, who had been exposed to multiple adverse life events, were randomly assigned to either a Trauma Focused Cognitive Behavioural Therapy group or a non trauma based psychosocial intervention ( Child Friendly Spaces). Non clinically trained, Congolese facilitators ran both groups. A convenience sample, waiting list group was also formed. Using blind assessors, participants were individually interviewed at pre intervention, post intervention and a 6-month follow-up using self-report post-traumatic stress and internalising symptoms, conduct problems and pro social behaviour. Both treatment groups made statistically significant improvements, compared to the control group. Large, within subject, effect sizes were reported at both post intervention and follow-up. At the 6-month follow-up, only the Child Friendly Spaces group showed a significant decrease in pro social behaviour. The paper concludes that both trauma focused and non trauma focused interventions led to reductions in psychological distress in war affected youth. [ABSTRACT FROM AUTHOR]

Background The effectiveness of two treatment approaches (phonological therapy and articulation therapy) for treatment of 14 children, aged 4;0-6;7 years, with phonologically based speech-sound disorder (SSD) has been previously analysed with severity outcome measures (percentage of consonants correct score, percentage occurrence of phonological processes and phonetic inventory). Considering that the ultimate goal of intervention for children with phonologically based SSD is to improve intelligibility, it is curious that intervention studies focusing on children's phonology do not routinely use intelligibility as an outcome measure. It is therefore important that the impact of interventions on speech intelligibility is explored. Aims This paper investigates the effectiveness of the two treatment approaches (phonological therapy and articulation therapy) using intelligibility measures, both in single words and in continuous speech, as the primary outcome. Methods & Procedures Fourteen children with phonologically based SSD participated in the intervention. The children were randomly assigned to phonological therapy or articulation therapy (seven children in each group). Two assessment methods were used for measuring intelligibility: a word identification task (for single words) and a rating scale (for continuous speech). Twenty-one unfamiliar adults listened and judged the children's intelligibility. Reliability analyses showed overall high agreement between listeners across both methods. Outcomes & Results Significant improvements were noted in intelligibility in both single words (paired t(6) = 4.409, p = 0.005) and continuous speech (asymptotic Z = 2.371, p = 0.018) for the group receiving phonology therapy pre- to post-treatment, but no differences in intelligibility were found for those receiving the articulation therapy pre- to post-treatment, either for single words (paired t(6) = 1.763, p = 0.128) or continuous speech (asymptotic Z = 1.442, p = 0.149). Conclusions & Implications Intelligibility measures were sensitive enough to show changes in the phonological therapy group but not in the articulation therapy group. These findings emphasize the importance of using intelligibility as an outcome measure to complement the results obtained with other severity measures when exploring the effectiveness of speech interventions. This study presents new evidence for the effectiveness of phonological therapy in improving intelligibility with children with SSD. [ABSTRACT FROM AUTHOR]

Background Previous studies have reported that obese people with trisomy 21 suffer from lowgrade systemic inflammation. A recent study has found that aerobic training reduced inflammation in obese women with Down syndrome. To the best of our knowledge, the study reported in this paper is the first to determine for how long these effects were maintained after completion of the programme. Methods Twenty premenopausal obese women (18-30 years old) with Down syndrome volunteered for this study. Eleven were randomly assigned to the intervention group and performed a 10-week aerobic training programme, 3 sessions per week, consisting of warming-up followed by treadmill exercise (30-40 min) at a work intensity of 55-65% of peak heart rate and a cooling-down period. The control group included 9, age, sex and BMI matched women with Down syndrome that did not perform any training programme. Fat mass percentage and distribution were measured. Plasma level of IL-6 and high-sensitive C-reactive protein (hs-CRP) were monitored. Time-course changes for these outcomes were assessed at pre- and post-intervention. Further, they were re-evaluated at 1, 3 and 6 months after completion of the programme. Results Three months after completion of the programme, plasma levels of IL-6 and hs-CRP were significantly increased. Up to 6 months later, both fat mass percentage and waist circumference (WC) were significantly increased. Furthermore, physical fitness was also impaired in the intervention group. No changes were observed in the control group. Conclusion A 3-month detraining period significantly impaired chronic inflammation in obese women with DS. [ABSTRACT FROM AUTHOR]

Background: Frailty is associated with poor outcomes among older adults with hypertension and complicates its pharmacological management. Here, we assessed whether 12-weeks of instructor-guided, group Tai Chi (TC) practice improved frailty relative to Healthy Aging Practice-centered Education (HAP-E) classes in older adults with hypertension. Methods: Secondary analysis of a randomized controlled trial in San Diego County, USA, of 167 community-dwelling individuals aged ≥ 60 yrs (70% female; 72.1 ± 7.5 yrs), defined as non-frail (66%) or frail (34%) based on 53-item deficit accumulation frailty index (FI). Linear mixed-effects models were used to assess pre-to-post intervention differences in FI and logistic regression to explore differential odds of clinically meaningful FI change. Results: One hundred thirty-one participants completed post-intervention assessments. Frailty decreased pre-to-post intervention in the TC (ΔFI = − 0.016, d = − 0.39, − 0.75 to − 0.03), but not the HAP-E arm (ΔFI = − 0.009, d = − 0.13, − 0.52–0.27), despite no significant group differences between the TC and HAP-E arms (d = − 0.11, − 0.46–0.23). Furthermore, greater odds of improved FI were observed for frail participants in the TC (OR = 3.84, 1.14–14.9), but not the HAP-E (OR = 1.34, 0.39–4.56) arm. Subgroup analysis indicated treatment effects in TC were attributed to frail participants (frail: ΔFI = − 0.035, d = − 0.68, -1.26 to − 0.08; non-frail: ΔFI = − 0.005, d = − 0.19, − 0.59–0.22), which was not the case in the HAP-E arm (frail: ΔFI = − 0.017, d = − 0.23, − 0.81–0.35; non-frail: ΔFI = − 0.003, d = − 0.07, − 0.47–0.33). Frail participants were no more likely to drop-out of the study than non-frail (71% vs. 69% retained). Conclusions: Twelve weeks of twice-weekly guided TC practice was well-tolerated, associated with decreases in frailty, and increased odds of clinically meaningful FI improvement at post-intervention. [ABSTRACT FROM AUTHOR]

Integration of vocational rehabilitation and mental healthcare has shown some effect on work participation at 1-year follow-up after sick leave with depression and anxiety. We aimed to study the effect on work and health outcomes at 2-year follow-up, why we performed a randomized trial was conducted to study the effectiveness of integrated intervention (INT) compared to service as usual (SAU) and best practice mental healthcare (MHC). We included 631 participants, and at 24-month follow-up, we detected no differences in effect between INT and SAU. Compared to MHC, INT showed faster return-to-work (RTW) rates (p = 0.044) and a higher number of weeks in work (p = 0.024). No symptom differences were observed between the groups at 24 months. In conclusion, compared to SAU, INT was associated with a slightly higher work rate reaching borderline statistical significance at 12-month follow-up and lower stress levels at 6-month follow-up. The disappearance of relative effect between 12 and 24 months may be explained by the fact that the intervention lasted less than 12 months or by delayed spontaneous remission in the SAU group after 12 months. Despite the lack of effect at long-term follow-up, INT still performed slightly better than SAU overall. Moderate implementation difficulties, may partly explain the absence of the hypothesized effect. Integrated intervention, as implemented in this trial, showed some positive effects on mid-term vocational status and short-term stress symptom levels. However, these effects were not sustained beyond the duration of the intervention. [ABSTRACT FROM AUTHOR]

This online randomised controlled study evaluates benefits associated with structured topic-focussed narrative writing tasks versus unstructured narrative writing tasks, monitoring to what extent tasks impact well-being, psychopathology and satisfaction. Participants were randomised to structured topic-focussed or unstructured narrative writing conditions. Structured condition consisted of Conflict Analysis (CA), a self-guided narrative-based therapeutic assessment. Unstructured conditions consisted of narrative disclosure tasks about traumatic experiences. Both conditions consisted of ten 20-minute tasks completed within one week. One hundred and three participants completed baseline measures. Eighty-two participants completed two-week follow-up measures. Repeated measure ANOVA and t-tests were used to evaluate differences over time. Follow-up data suggest that CA participants had significantly improved outcomes when compared to narrative disclosure participants. Evidence supports continued structured narrative writing research. [ABSTRACT FROM AUTHOR]

Objective: To investigate the effects of multidirectional elastic tape on pain and function in individuals with lateral elbow tendinopathy. Study Design: Randomised crossover trial. Setting: Biomechanics laboratory. Subjects: 27 participants (11 females, mean (SD) age: 48.6 (11.9) years) with clinically diagnosed lateral elbow tendinopathy of at least six weeks' duration. Interventions: Tensioned multidirectional elastic tape applied over the wrist, compared to control tape (untensioned), and no tape conditions. Main measures: Pain-free grip strength and pressure pain threshold were recorded at three timepoints for each condition: baseline, post-application, and following an exercise circuit. Change scores were calculated as the post-application or post-exercise value minus baseline. Repeated-measure analyses of variance were used to examine differences between conditions. Results: There were no statistically significant differences in pain-free grip strength between conditions (flexed position: F2,52 = 0.02, p = 0.98; extended position: F2,52 = 2.26, p = 0.12) or across timepoints (post-application vs post-exercise) (flexed position: F1,26 = 0.94, p = 0.34; extended position: F1,26 = 0.79, p = 0.38). Seven participants (26%) increased pain-free grip strength above the minimal detectable change following application of multidirectional elastic tape. There were no statistically significant differences in pressure pain threshold between conditions (affected lateral epicondyle: F1.51,39.17 = 0.54, p = 0.54) or across timepoints (affected lateral epicondyle: F1,26 = 0.94, p = 0.34). Conclusion: Tensioned multidirectional elastic tape may not immediately improve pain-free grip strength or pressure pain threshold in our lateral elbow tendinopathy population; however, individual variation may exist. [ABSTRACT FROM AUTHOR]

Introduction Whiplash-associated disorder (WAD) often becomes a persistent problem and is one of the leading causes of disability in the world. It is a costly condition for individuals, for insurance companies, and for society. Guidelines for the management of WAD have not been updated since 2014, and the use of computer-based sensorimotor exercise programs in treatment for this patient group has not been well documented. The purpose of this randomized clinical trial is to explore the degree of association between self-reported and clinical outcome measures in WAD. Methods Individuals (n  = 180) with subacute WAD grades I and II will be randomized into 3 groups using block randomization. The 2 primary intervention groups (A and B) will receive physical therapy involving manual therapy and either a remote, novel, computer-based cervical kinesthetic exercise (CKE) program starting at visit 2 (Group A) or neck exercises provided by the corresponding physical therapist (Group B). These groups will be compared to a "treatment as usual" Group C. Movement control, proprioception, and cervical range of motion will be measured. Neck disability and pain intensity, general health, self-perceived handicap, and physical, emotional, and functional difficulties due to dizziness will be measured using questionnaires. The short-term effects will be measured 10 to 12 weeks after the baseline measurements, and the long-term effects will be measured 6 to 12 months after the baseline measurements. Impact The successful completion of this trial will help guide clinicians in the selection of outcome measures for patients with subacute WAD in the assessment of the short- and long-term effectiveness of treatment combining manual therapy with computer-based CKE compared with manual therapy and non–computer-based exercises. This trial will also demonstrate the potential of using a computer-based intervention to increase the exercise dose for this patient group and how this influences outcomes such as levels of pain and disability in the short and long term. [ABSTRACT FROM AUTHOR]

Meniscal injuries are one of the most common intra-articular knee injuries. Different treatments are presented depending on the symptoms and duration of meniscus tears, such as arthroscopic partial meniscectomy, physiotherapy, or even pharmacological treatment. The purpose was to investigate the effect of a concentric isokinetic knee muscle strengthening program on strength, joint range of motion, physical performance, quality of life and pain tolerance in overweight/obese women with chronic meniscal lesions. Twenty-four overweight/obese women were randomized into two groups. A control group (CG) performed a usual rehabilitation program plus isokinetic muscle strengthening (IMS) in the continuous passive motion mode and measured with an isokinetic dynamometer. An experimental group (EG) performed the same program in combination with IMS in the isokinetic active mode. The peak torque of the knee extensors (PTE) and flexors (PTF), sit-to-stand test, stair climb test, joint amplitude, heel-to-buttock distance, Thessaly test, KOOS questionnaire of pain and quality of life were measured pre- and post-protocol. After the intervention, the sit–stand number for both groups was significantly higher (p < 0.001) and the time to climb stairs was significantly reduced for the EG (p < 0.001). A significant improvement in joint range of motion, life quality (p < 0.001), relief in knee pain (p < 0.001) and in the post-program evaluation at the EG (p < 0.05) was noted. There was no significant difference in PTE and PTF between groups at 60°/s and 180°/s. The IMS in the active mode could be an effective therapeutic modality in managing middle-aged patients suffering from a degenerative meniscal tear. [ABSTRACT FROM AUTHOR]

Objective: To compare the sealing ability and marginal adaptation of three calcium silicate-based cement (Biodentine, Pro root MTA, MTA Angelus) using a bacterial leakage model and scanning electron microscope (SEM). Methods: Recently extracted lower first premolars were randomly categorized into three experimental groups (n = 15 samples), positive control (n = 5 samples), and negative control group (n = 5 sample). Samples from the experimental groups and positive control group were subject to cavity Class I occlusal preparation followed by modified coronal pulpotomy. Different types of bioceramic dressing material were placed in 3 mm thickness accordingly, group 1 (Biodentine), group 2 (MTA Angelus), and group 3 (ProRoot MTA). No dressing material was placed in the positive control group (group 4). All samples were placed in the incubator for 24 h at 37℃, 100% humidity, for the materials to be completely set. The final restoration was placed using the Z350 resin composite. A double layer of nail varnish was applied over all the sample surfaces except the occlusal site. Whereas the samples' surfaces in the negative control, were completely covered. A 3 mm length was measured from the root apex of the samples from each group, before proceeding with the resection. The bacterial leakage test was performed using Enterococcus faecalis TCC 23,125, and a sample from each experimental group was randomly chosen for SEM. Data analysis was conducted under the One-way ANOVA test, completed by Tukey's post hoc test. Results: There is a significant difference in sealing ability and marginal adaptation between the groups. (p < 0.05). The study showed that Pro Root MTA had the superior sealing ability and marginal adaptation compared to Biodentine and MTA Angelus. Conclusion: The ProRoot MTA as a coronal pulpotomy pulp dressing material, was found to have a better marginal adaptation and sealing ability compared to three other bioceramics materials. The material would be the better choice during clinical settings and procedures. [ABSTRACT FROM AUTHOR]

Background: Children's pain in dentistry has undesirable short‐ and long‐term consequences; therefore, less invasive treatments merit consideration. Aim: To investigate procedural pain scores for two treatments for carious primary molars in New Zealand primary care. Design: This study was a split‐mouth randomised control trial, with secondary outcome analysis. Children (4–8 years) with proximal carious lesions on matched primary molars had one tooth treated with the Hall technique (HT) and one treated with a conventional stainless steel crown (CT); treatment type and order of treatment were randomly allocated (allocation concealment). The Wong–Baker self‐report pain scale measured pretreatment dental pain, procedural pain at each treatment and post‐operative pain. Results: Data were analysed for 103 children: 49 children had the HT first and 54 children had the CT first. Procedural pain scores did not differ by treatment type, with 71.8% and 76.7% of children reporting low pain for the HT and the CT, respectively. Fewer children reported low procedural pain for the second treatment than the first (p =.047). Most children reported low procedural pain for both treatments (58.3%), although 41.7% experienced moderate–high procedural pain with at least one treatment. Conclusions: The HT caused pain for as many children as the CT. There is an opportunity for better dental pain management in this setting. [ABSTRACT FROM AUTHOR]

Background There is limited knowledge of whether cognitive-behavioral therapy (CBT) or second-generation antipsychotics (SGAs) should be recommended as the first-line treatment in individuals at clinical high risk for psychosis (CHRp). Hypothesis To examine whether individual treatment arms are superior to placebo and whether CBT is non-inferior to SGAs in preventing psychosis over 12 months of treatment. Study Design PREVENT was a blinded, 3-armed, randomized controlled trial comparing CBT to clinical management plus aripiprazole (CM + ARI) or plus placebo (CM + PLC) at 11 CHRp services. The primary outcome was transition to psychosis at 12 months. Analyses were by intention-to-treat. Study Results Two hundred eighty CHRp individuals were randomized: 129 in CBT, 96 in CM + ARI, and 55 in CM + PLC. In week 52, 21 patients in CBT, 19 in CM + ARI, and 7 in CM + PLC had transitioned to psychosis, with no significant differences between treatment arms (P  = .342). Psychopathology and psychosocial functioning levels improved in all treatment arms, with no significant differences. Conclusions The analysis of the primary outcome transition to psychosis at 12 months and secondary outcomes symptoms and functioning did not demonstrate significant advantages of the active treatments over placebo. The conclusion is that within this trial, neither low-dose aripiprazole nor CBT offered additional benefits over clinical management and placebo. [ABSTRACT FROM AUTHOR]

Background: Trigger point (TrP) acupuncture is commonly used to treat chronic non-specific low back pain (CNLBP). Evidence for the efficacy of most TrP acupuncture modalities is weak or lacking. Objective: To assess the effect of TrP acupuncture on pain, disability, gait and muscle activation in patients with CNLBP. Methods: From May 2019 to February 2020, a randomised, single-blind clinical trial was carried out involving 33 participants with CNLBP, divided into one of two intervention groups or a control group (n = 11 per group). The intervention groups received TrP acupuncture or traditional acupuncture treatment three times a week for 4 weeks, and the control group remained on a waiting list and received no treatment. Pain, disability, gait and muscle activation were assessed at baseline and at 4 and 8 weeks of follow-up. Results: At baseline, the three groups showed no significant differences in age, gender, height, weight, body mass index (BMI) or disease course (p ⩾ 0.05). At 4 weeks, pain was relieved (measured by visual analogue scores, p = 0.036) and disability was improved (reflected by lower Oswestry disability index scores, p = 0.029) in TrP acupuncture versus waiting list groups. Moreover, lumbar extension range of motion was increased in TrP acupuncture versus both traditional acupuncture and waiting list groups (p = 0.029 and p = 0.027, respectively). At 8 weeks, there were no significant differences in any parameter between the three groups (p > 0.05). Conclusion: TrP acupuncture had a significant short-term effect on pain relief and disability in patients with CNLBP, but there was no evidence of a long-term influence (at 8 weeks following the intervention). Further high-quality randomised controlled trials are needed for verification in the future. Trial registration number: ChiCTR1900022838 (Chinese Clinical Trial Registry) [ABSTRACT FROM AUTHOR]

Purpose: Diabetes remission is a phenomenon described in the context of drastic weight loss due to bariatric surgery or low-calorie diets. Evidence suggests that increasing the intake of plant protein could reduce the risk of type 2 diabetes. We sought for association between changes in plant protein intake in the context of 2 healthy diets without weight loss nor glucose-lowering medication, and diabetes remission in coronary heart disease patients from the CORDIOPREV study. Methods: Newly diagnosed type 2 diabetes participants without glucose-lowering treatment were randomized to consume a Mediterranean or a low-fat diet. Type 2 diabetes remission was assessed with a median follow-up of 60 months according to the ADA recommendation. Information on patient's dietary intake was collected using food-frequency questionnaires. At first year of intervention, 177 patients were classified according to changes in plant protein consumption into those who increased or decreased its intake, in order to perform an observational analysis on the association between protein intake and diabetes remission. Results: Cox regression showed that patients increasing plant protein intake were more likely to remit from diabetes than those who decreased its intake (HR = 1.71(1.05–2.77)). The remission occurred mainly at first and second year of follow-up with diminished number of patients achieving remission in the third year onwards. The increase in plant protein was associated with lower intake of animal protein, cholesterol, saturated fatty acids, and fat, and with higher intake of whole grains, fibre, carbohydrates, legumes, and tree nuts. Conclusion: These results support the need to increase protein intake of vegetal origin as dietary therapy to reverse type 2 diabetes in the context of healthy diets without weight loss. [ABSTRACT FROM AUTHOR]

Aims Supervised exercise is a guideline-recommended treatment in intermittent claudication (IC). Hospital-based supervised exercise programmes (SEPs) are underutilized, while home-based structured exercise programmes (HSEPs) have attracted interest. The results from HSEP in IC are inconsistent and may confer no benefit over walk advice (WA) and be less effective than SEP. The aim of the study was to compare the effectiveness of best medical treatment, including Nordic pole WA alone, or WA + SEP or WA + HSEP for patients with IC. Methods and results This three-armed, multicentre randomized clinical trial enrolled patients with IC; all patients received best medical treatment including walking poles and the advice of regular Nordic pole walking (WA). For HSEP and SEP, additional exercise programmes were provided. The primarily investigated hypothesis was a non-inferiority analysis of SEP vs. HSEP regarding the 6-min walk test (6MWT) maximum distance, with a pre-defined non-inferiority margin of 50 m. Supporting outcomes included muscle endurance tests and the walking impairment questionnaire. Outcomes were assessed at baseline, 3, 6, and 12 months by a blinded evaluator. Altogether 166 patients (mean age 72 years; 59% males) were randomized. In HSEP and SEP, 24 and 26% patients, respectively, were fully exercise adherent. All three groups improved pain-free walking distance over time, but there were no significant intergroup differences. The intergroup 6MWT difference between SEP and HSEP from 0 to 12 months was –11.6 m, 95% confidence interval: –36.4 to 13.0 m (i.e. within the pre-specified non-inferiority margin). Conclusion The HSEP was non-inferior to SEP in patients with IC. There were no significant differences observed between the three groups at 1 year. Registration ClinicialTrials.gov: NCT02341716. [ABSTRACT FROM AUTHOR]

This study aimed to evaluate the effect of a home-based self-management intervention in community-dwelling patients with early Parkinson's diseases (PD). A randomized-controlled design. Thirty-two patients participated (15=intervention, 17=control), and the intervention group received 16 weeks of the intervention. Physical activity and non-motor symptoms improved more in the intervention group than in the control group. Home-based self-management intervention was effective in improving physical activity and non-motor symptoms for them. Home-based intervention – comprising education, telephone counseling, smartphone-based message and information, and smart wearable devices – was feasible for patients with early PD. [ABSTRACT FROM AUTHOR]

Objective: This study compared in vitro the anastomosis cleaning efficacy of different irrigant activation techniques at different levels; control group non-activation (NA), passive ultrasonic irrigation (PUI) using Irrisafe, and EDDY sonic activation. Methods: Sixty anastomosis-containing mesial roots of mandibular molars were mounted in resin, sectioned at 2, 4, and 6 mm from the apex. Then reassembled and instrumented in a copper cube. For the irrigation technique roots were randomly divided into 3 groups (n = 20): group 1: NA, group 2: Irrisafe, group 3: EDDY. Stereomicroscopic images of anastomoses were taken after instrumentation and after irrigant activation. ImageJ program was used to calculate the percentage of anastomosis cleanliness. The percentage of cleanliness was calculated before and after final irrigation within each group and were then compared using paired t-tests. Intergroup and intragroup analyses were performed to compare between different activation techniques at the same root canal level (2, 4 and 6 mm) (intergroup) and to evaluate if each technique had different cleanliness efficacy according to the root canal level (intragroup) using one-way analysis of variance and post hoc tests (p < 0.05). Results: All three irrigation techniques significantly improved anastomosis cleanliness (p < 0.001). Both activation techniques were significantly better than the control group at all levels. Intergroup comparison revealed that EDDY significantly achieved the best overall anastomosis cleanliness. The difference between EDDY and Irrisafe was significant in favor to EDDY at 2 mm and insignificant at 4 and 6 mm. The intragroup comparison showed that improvement in anastomosis cleanliness (i2-i1) in the needle irrigation without activation group (NA) was significantly higher in the apical 2 mm level compared to the 4 & 6 levels. While the difference in anastomosis cleanliness improvement (i2-i1) between levels in both Irrisafe and EDDY groups was insignificant. Conclusions: Irrigant activation improves anastomosis cleanliness. EDDY was the most efficient in cleaning anastomoses located in the critical apical part of the root canal. Clinical relevance: Cleaning and disinfection of the root canal system followed by apical and coronal sealing is the key for healing or prevention of apical periodontitis. Remnants of debris and microorganisms retained within the anastomoses (isthmuses), or other root canal irregularities may lead to persistent apical periodontitis. Proper irrigation and activation are essential for cleaning root canal anastomoses. [ABSTRACT FROM AUTHOR]

Background: This study aimed to compare the effect of Clinpro™ White varnish containing 5% sodium fluoride (NaF) and functionalized tricalcium phosphate, MI varnish containing 5% NaF and casein phosphopeptide-amorphous calcium phosphate (CPP-ACP), and 38% Silver diamine fluoride (SDF) in preventing demineralization of treated white spot lesions (WSLs) in enamel of primary teeth. Methods: Forty-eight primary molars with artificial WSLs were allocated into four groups as follows: Group 1: Clinpro white varnish, Group 2: MI varnish, Group 3: SDF, and Group 4: control (no treatment). The three surface treatments were applied for 24 h and then enamel specimens were subjected to pH cycling. Thereafter, the mineral content of specimens was evaluated by Energy Dispersive X-ray Spectrometer and the lesion depth was assessed via Polarized Light Microscope. One-way ANOVA followed by Tukey's post hoc test were used at p ≤ 0.05 to identify significant differences. Results: Insignificant difference in mineral content was observed among treatment groups. Treatment groups exhibited significantly higher mineral content compared to control except for Fluoride (F). MI varnish showed the highest mean calcium (Ca) ion content (66.57 ± 0.63), and Ca/P (2.19 ± 0.11), followed by Clinpro white varnish, and SDF. MI varnish also displayed the highest phosphate (P) ion content (31.46 ± 0.56), followed by SDF (30.93 ± 1.02), and Clinpro white varnish (30.53 ± 2.19). Fluoride content was highest in SDF (0.93 ± 1.18), followed by MI (0.89 ± 0.34) and Clinpro (0.66 ± 0.68) varnishes. Significant difference in lesion depth was observed among all groups (p < 0.001). The lowest mean lesion depth (µm) was found in MI varnish (226.23 ± 44.25) which was significantly lower than Clinpro white varnish (285.43 ± 44.70), SDF (293.32 ± 46.82), and control (576.69 ± 42.66). Insignificant difference in lesion depth was found between SDF and Clinpro varnish. Conclusions: In primary teeth, WSLs treated with MI varnish displayed better resistance to demineralization compared to WSLs treated with Clinpro white varnish and SDF. [ABSTRACT FROM AUTHOR]

Background and aim: Previous studies have shown that Rheum ribes (R. ribes) could be effective in controlling the blood glucose levels. This study was conducted to determine the effects of R. ribes supplementation on glycemic indices and apolipoproteins in patients with type 2 diabetes mellitus (T2DM). Methods: In the present randomized double-blind controlled trial, 60 type 2 diabetic patients aged 30–60 years with a body mass index (BMI) of 20–30 kg/m2 and hemoglobin A1c (HbA1c) of 6–8% were enrolled. Patients were randomly assigned to receive 450 mg of aqueous R. ribes extract (AG), 450 mg of ethanolic R. ribes extract (EG), or placebo (PG) three times daily for 6 weeks. At the baseline and at the end of the study, blood glucose levels, homeostatic model assessment of insulin resistance (HOMA-IR) and the homeostatic model assessment of β-cell dysfunction (HOMA-B), as well as apolipoprotein A-I (ApoA1) and apolipoprotein B (ApoB) were measured. Results: There was a significant decrease in the serum levels of insulin in AG and EG groups (P = 0.003 and P = 0.001, respectively), HOMA-IR (P = 0.01 and P = 0.001, respectively), HOMA-B (P = 0.002 and P = 0.001, respectively), ApoB (P = 0.006 and P = 0.03, respectively), ApoB/ApoA1 ratio (P = 0.016 and P = 0.04, respectively). However, a significant increase in ApoA1 (P = 0.08 and P = 0.05, respectively) with no significant changes in blood glucose, at the end of study compared to beginning values, were observed. None of the variables showed a significant change in PG. At the end of the study; while there were significant differences in insulin (P = 0.04), HOMA-IR (P = 0.03), HOMA-B (P = 0.01), ApoB (P = 0.02), and ApoB/ApoA1 ratio (P = 0.03) among the groups but ApoA1 had no significant change. Conclusion: Consumption of R. ribes intake could have beneficial effects on insulin resistance and apolipoproteins in type 2 diabetic patients. (Registered at en.irct.ir, identification number: IRCT201410142709N31). [ABSTRACT FROM AUTHOR]

Twenty percent of youth experience psychiatric illness before they reach adulthood, yet most do not receive adequate mental health services. Youth of color are particularly vulnerable to psychopathology considering they are more likely to experience adversity, stress, and barriers to treatment compared to White youth. Schools offer an ideal setting to address barriers to mental health care access and disparities affecting youth of color. The current study investigated the effectiveness of a school-based psychotherapy intervention for underserved youth. Participants were 141 children (ages 9–12 years; 37% Hispanic/Latinx, 58% Black/African American) assigned to either immediate or delayed intervention with the Resilience Builder Program® (RBP), a resilience group intervention for youth with social competence and emotion regulation deficits. Repeated measures analysis of variance examined differences between immediate and delayed intervention groups. Immediate intervention participants demonstrated significant improvement across behavioral, social, emotional, and executive functioning domains compared to those in the delayed intervention group. After per-family Bonferroni correction, improvements in teacher-rated emotional self-control remained statistically significant. Examination of effect sizes indicated greatest improvement across parent- and teacher-reported emotional regulation. Findings suggest that RBP demonstrates potential as an effective resilience school-based intervention for youth, especially in the realm of emotion regulation. Results also offer encouragement for universal applications of RBP to classroom settings in the future. Highlights: School-based interventions address barriers to mental health care access that disproportionately affect youth of color. This randomized controlled trial examined effectiveness of a school-based resilience intervention for underserved youth. The Resilience Builder Program® is a group intervention targeting wide-ranging social competence deficits. Results demonstrated greatest improvements in domains of emotional regulation across parent and teacher report. [ABSTRACT FROM AUTHOR]

Background: Increased sperm DNA damage is known as one of the causes of recurrent pregnancy loss (RPL) which can be due to increased levels of oxidative stress. Therefore, the aim of this study was to assess the effect of alphalipoic acid (ALA) on sperm parameters and sperm functions in couples with a history of RPL. Materials and Methods: In this post hoc analysis in clinical trial study, a total of 37 couples with RPL (n=12 and n=25 for placebo and ALA groups, respectively) were considered. Men were treated with ALA (600 mg/day) or placebo for 80 days. Semen samples were acquired from the participants before initiation and after completion of the medication course and assessed regarding conventional sperm parameters, chromatin damage/integrity, intracellular oxidative stress, lipid peroxidation, and seminal antioxidant characteristics. Individuals were further followed up for twelve months for pregnancy occurrence and outcomes. Finally, after excluding patients with no history of RPL, the data was analyzed. Results: No significant differences were observed between the baseline measures of the aforementioned parameters except for seminal volume. After the intervention, the mean sperm DNA damage, protamine deficiency, and persisted histones were significantly lower in the ALA group than in placebo receivers (P<0.05). A decrease in the mean of seminal total antioxidant capacity (P=0.03), malondialdehyde (P=0.02), and sperm DNA damage (P=0.004) as well as an increase in sperm total motility (P=0.04) after treatment with ALA was noticed. In addition, the mean of protamine deficiency and persisted histones were declined post-ALA therapy (P=0.003 and 0.002, respectively). The percentage of spontaneous pregnancy in the ALA group (4 of 25 cases; 16%) was higher than in the placebo group (1 of 12, 8.3%). Conclusion: ALA-therapy attenuates sperm DNA damage and lipid peroxidation while enhancing sperm total motility and chromatin compaction in the male partner of couples with PRL (registration number: IRCT20190406043177N1). [ABSTRACT FROM AUTHOR]

Background: Diabetic Foot Ulcers (DFUs), a serious complication of diabetes, have limited solutions in conventional therapies. The condition needs holistic management of blood glycemic levels; foot wounds; and possible regeneration of nerves in the soles of patients. Objective: To evaluate the efficacy of Pranic Healing as a complimentary therapy in managing Diabetic Foot Ulcers (DFUs). Methods: Thirty diabetic subjects already on standard therapy for Diabetes, co morbidities and wound care for Diabetic Foot Ulcers were assigned on a 1:1 basis to the trial and control groups. While both groups continued to receive standard therapy, the trial group additionally received Pranic Healing therapy. The Clinician, nursing staff, assessors and patients were blinded. Pranic Healers carried out healing on the trial group remotely, every day for 50 to 60 minute for stress, diabetes, local wound healing, blood cleansing and regeneration of nerves in the soles. The efficacy variables were the mean change from baseline in wound parameters and grade of DFU, overall well-being and HbAlc levels. Results: At the end of the trial, about 83.33% participants in the trial group demonstrated lowering of size and severity of the ulceration and improved to a lower grade of DFU compared to 44.4% in control group. The trial group reported a significant reduction in wound area and HbA1c levels. The trial group showed better readings for improved sensory perception in the soles through changes in the large fibre dysfunction and damaged nerves as compared to the control group. Approximately 76.9% of participants in the trial group reported lower stress levels compared to 22.22% in the control group. Conclusions: Pranic Healing intervention can be a safe and effective adjunct in managing Diabetic Foot Ulcers. [ABSTRACT FROM AUTHOR]

It is believed that clinical management of osteoarthritis should address muscle weakness to improve physical function and prevent disability and frailty This sub-study investigated the effects of supervised progressive resistance training (RT), supervised Nordic Walking (NW), and unsupervised home-based exercise (HBE) on muscle and functional performance; and associations between these exercise-induced changes in persons with hip osteoarthritis. Forty-two patients with hip osteoarthritis were recruited from a larger RCT (NCT01387867). All the groups (RT, n = 15; NW, n = 12; HBE, n = 15) exercised 1 h 3 times/week for 4 months. Quadriceps cross-sectional area (QCSA, MRI-determined); quadriceps strength (QMVC); leg extensor power (LEP); functional performance (chair stands (30sCS); stair climbs (TSC); and 6-minute walk (6MWT)) were assessed at baseline and 4 months. Per protocol analyses (one-way ANOVA and Bonferroni test) showed significant between-group differences for improvements in QCSA in the most symptomatic leg favoring RT versus NW (2.3 cm2, 95% CI [0.6, 3.9]) and HBE (2.3 cm2 [0.8, 3.9]); and 30sCS (1.8 repetitions [0.2–3.3]), and 6MWT (35.1 m [3.5–66.7]) favoring NW versus HBE. Associations existed between exercise-induced changes in QCSA and QMVC (r = 0.366, p =.019) for the most symptomatic leg and between changes in 6MWT and QMVC (r = 0.320, p =.04) and LEP (r = 0.381, p =.01), respectively, for the least symptomatic leg. Resistance training appeared effective for improving muscle mass, but less effective for improving muscle strength, power, and functional performance. Only exercise-induced changes in muscle strength and power of the least symptomatic leg, not the most symptomatic leg, were related to changes in functional performance. [ABSTRACT FROM AUTHOR]

To examine the effects of web-based SUpport PRogram (SUPR) for communication partners (CPs) of persons with hearing loss (PHLs) in a HA dispensing setting. Cluster randomised controlled trial (cRCT) with two arms (SUPR: Booklet, online videos; care as usual: no support) plus process evaluation. Measurements: baseline, and immediately-, six, and 12 months post-intervention. Outcomes: Significant Other Scale for Hearing Disability (SOS-HEAR), International Outcome Inventory for HAs/Alternative Interventions for Significant Others (IOI-HA/AI-SO). Process evaluation: dose-received, satisfaction, and benefit. The cRCT included 73 (SUPR) and 57 (care as usual) CPs. In the process evaluation study, 41 CPs (SUPR) participated. There were no significant effects of SUPR for third-party disability (SOS-HEAR), the proxy report (IOI-HA-SO item "use"), and third-party disability (IOI-HA-SO items "satisfaction", and "quality of life"). SUPR-videos were watched by 15-22% of the CPs. SUPR materials were rated as moderately beneficial and useful. Low baseline disability (floor effect) and low intervention dose-received may explain the findings. Directly targeting CPs rather than via their PHLs and providing intervention materials specifically for CPs may improve their engagement and contribute to SUPR's value supplementary to standard HA care. [ABSTRACT FROM AUTHOR]

Introduction: Preoperative anxiety before cesarean section is a major issue. Nonpharmacologic anxiety control is believed to be more suitable in pregnant women. Auricular acupuncture (AA) is an inexpensive, easy-to-use, and validated intervention to reduce anxiety in different surgical settings. We evaluated the effect of AA on preoperative cesarean section anxiety. Methods: In a prospective, blind, controlled trial, pregnant women with a scheduled cesarean section under spinal anesthesia were randomized to receive AA with needle, AA without needle (sham), or usual care (no intervention). Anxiety level was assessed by using a visual analogue scale for anxiety (VAS-A; 0-minimal anxiety, 100-maximal anxiety) at three time points: inclusion (pre-induction room--T0), when entering the operating room (T1), and before incision (T2). The primary outcome was the VAS-A variation (percentage changes) between T0 and T1 in the AAe group compared with that in the sham AA group. The secondary outcomes were the VAS-A variation between T0 and T1 in the AA group compared with that in the control group, and the variation between T0 and T2 compared between the three groups, the effect of AA on parasympathetic tone, and the incidence of adverse effects. Results: In women immediately before anesthesia for cesarean section, the AA produced a 19% decrease of anxiety, compared with a 21% anxiety increase in sham AA, which is significantly different. The effect of AA was more present in women with low initial anxiety. The proportion of patients reaching clinically significant anxiety reduction (>33% from the initial level) was 2.5 times higher in the AA group ( p = 0.02) compared with the sham group. No differences in anxiety variations were found compared with the no-intervention group. No effect of AA was noted on parasympathetic tone. Conclusion:Comparedwith sham,AAdecreasedmaternal anxiety levelwhen arriving in the operation roomand just before the beginning of the cesarean section, with a trend toward improvement compared with usual care. [ABSTRACT FROM AUTHOR]

The effect of directly observed therapy (DOT) versus self-administered therapy (SAT) on antiretroviral (ART) adherence and virological outcomes in prison has never been assessed in a randomized, controlled trial. Prisoners were randomized to receive ART by DOT or SAT. The primary outcome was medication adherence [percent of ART doses measured by the medication event monitoring system (MEMS) and pill counts] at the end of 24 weeks. The changes in the plasma viral loads from baseline and proportion of participants virological suppressed (<400 copies/mL) at the end of 24 weeks were assessed. Sixty-six percent (90/136) of eligible prisoners declined participation. Participants in the DOT arm ( n = 20) had higher viral loads than participants in the SAT ( n = 23) arm ( p = 0.23). Participants, with complete data at 24 weeks, were analyzed as randomized. There were no significant differences in median ART adherence between the DOT ( n = 16, 99% MEMS [IQR 93.9, 100], 97.1 % pill count [IQR 95.1, 99.3]) and SAT ( n = 21, 98.3 % MEMS [IQR 96.0, 100], 98.5 % pill count [95.8, 100]) arms ( p = 0.82 MEMS, p = 0.40 Pill Count) at 24 weeks. Participants in the DOT arm had a greater reduction in viral load of approximately −1 log 10 copies/mL [IQR −1.75, −0.05] compared to −0.05 [IQR −0.45, 0.51] in the SAT arm ( p value = 0.02) at 24 weeks. The proportion of participants achieving virological suppression in the DOT vs SAT arms was not statistically different at 24 weeks (53 % vs 32 %, p = 0.21). These findings suggest that DOT ART programs in prison settings may not offer any additional benefit on adherence than SAT programs. [ABSTRACT FROM AUTHOR]

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Aim: To test the effectiveness of nurse‐led dietary diabetes insipidus (DI) bundle on the severity of postoperative fluid imbalance in pituitary region tumours. Design: Blinded randomized controlled trial. Methods: Patients aged 18–65 operated for sellar–suprasellar tumours in an Indian tertiary care centre were enrolled through total enumeration sampling and underwent randomization with allocation concealment during Sep 2018–Feb 2019. Pre‐operative DI, postoperative ventilation, renal failure or decompensated diabetes mellitus were excluded. Patients in the intervention group received a nurse‐led DI bundle (validated by three Delphi rounds) with four dietary components: intake of only water during thirst and avoidance of the following—added salt, high‐protein foods and caffeinated drinks. Treating clinicians and the investigator assessing outcome were blinded about enrolment. Urine output, serum sodium, vasopressin requirement and hospital stay were assessed as primary outcomes. The outcome measures were monitored daily till the 6th postoperative day. Analyses were performed on 'intention‐to‐treat' basis, irrespective of compliance. Independent t‐test and Chi‐square test were used. Results: Of the initial 63 patients, 50 fulfilling criteria were randomized to two groups and assessed over six days yielding 150 patient‐days per group. There were no significant baseline differences between groups. The mean daily urine output was significantly lower in the DI bundle group than in control, both overall and among endonasal operated pituitary adenomas [3000.09(462.7) vs. 4095.71(896.4)ml & 2987.14(419.5) vs. 4064.73(1051)ml], with the greatest difference on the second postoperative day. Though hypernatraemia in controls became most prominent during days 2–3 and resolved in a week, it was significantly lower in the intervention group (12.7% vs. 30.7% overall, 11.4% vs. 29.4% endonasal adenomas). The need for vasopressin analogues and hospital stay were also significantly lower with DI bundle (p < 0.001). Conclusion: This is probably the first ever report of dietary DI bundle among operated pituitary patients, which seem to flatten the DI trend with significant benefits in polyuria, hypernatraemia, vasopressin requirement and hospital stay. Trial registration: CTRI/2018/07/015127 of ICMR. Impact: The nurse‐led dietary DI bundle has effectively reduced the severity of DI among operated pituitary patients with significant benefits in polyuria, hypernatraemia, vasopressin requirement and hospital stay. Its implementation is simple and easy to carry out, especially in resource‐constrained institutions, where continuous monitoring and repeated serum sodium estimation are difficult. [ABSTRACT FROM AUTHOR]

Objective: The longer-term effectiveness of silicone and pressure burn scar interventions was evaluated at 12-months postburn. Design: Parallel group, randomised trial. Setting: Hospital outpatient clinics, research centre. Participants: Children referred for burn scar management following grafted or spontaneously healed acute burn injuries or scar reconstruction surgery. Interventions: Participants were randomised to: (1) topical silicone gel only, (2) pressure garment only, or (3) combined topical silicone gel and pressure garment. Main measures: Primary outcomes were scar thickness (blinded ultrasound measurement) and itch intensity (caregiver proxy-report, numeric rating scale). Results: Of 153 participants randomised who received the interventions (silicone n = 51, pressure garment n = 49, combined n = 53), 86 were followed-up at 12-months postburn (n = 34, n = 28, n = 24). No differences were identified for the primary outcomes using intention-to-treat analysis. Scar thickness mean difference (95% confidence interval) = 0.00 cm (−0.04, 0.05); −0.03 cm (−0.07, 0.02); 0.03 cm (−0.02, 0.08) and scar itch = 0.09 (−0.88, 1.06); −0.21 (−1.21, 0.79); 0.30 (−0.73, 1.32) for silicone vs pressure; silicone vs combined and combined vs pressure respectively. No serious adverse effects occurred. Conclusion: Similar to short-term results, the combined intervention offered no statistically or clinically significant benefit for improving the primary outcomes compared to each intervention alone. No differences in the primary outcomes were identified between the silicone and pressure alone groups. [ABSTRACT FROM AUTHOR]

The purposes of this study were to reveal the effectiveness of an electric calendar, showing the date and schedule automatically for older people, and to prove the characteristics of appropriate users. The participants were 27 older adults with or without dementia (9 men and 18 women, mean age: 81.5 ± 6.9 years, range: 72–94 years). The study design was a cross-over randomized controlled trial, with 15 participants (55.6%) allocated to the first group to use the electric calendar, and 12 participants (44.4%) to the second intervention group. The outcome measures are daily behaviors and cognitive function assessed by the Mini-Mental State Examination and Neurobehavioral Cognitive Status Examination. Participants showed significant increase in total Mini-Mental State Examination score (p = 0.020, a paired t-test) after intervention period, whereas there was no significant difference after no intervention. Daily activities related healthcare were improved. The participants with positive outcomes showed higher motivations, and around 18 points in Mini-Mental State Examination. Most healthy older adults mentioned that electric calendars were useful, but unnecessary. Using the electric calendar was effective in improving global cognitive function and daily activities. The target users are older people, who (1) might have mild dementia, (2) have difficulties in daily activities, (3) can be supported by caregivers, and (4) have positive motivation to new technologies. An electric calendar is effective on grovel cognitive function, and activities of daily living related to healthcare in older adults, as well as reality orientation therapy. The electric calendar can be useful for older people with mild dementia or mild cognitive impairment, having difficulties activities of daily living, supported by caregivers at regular intervals. [ABSTRACT FROM AUTHOR]

Background: Chronic non‐cancer pain, which persists for at least three months, seriously affects quality of life. Chronic non‐cancer pain patients are usually managed by a multidisciplinary team using pharmacological and non‐pharmacological strategies. Nurses perform transcutaneous electrical nerve stimulation (TENS) and hypnosis, which are widely used in France for the treatment of chronic pain in pain departments. Objective: To assess pain relief at three months, comparing a simultaneous combination of hypnosis and TENS (intervention) with TENS alone (control). Design: Randomized controlled trial. Methods: Patients aged 18–80 years, suffering from chronic peripheral neuropathic and/or nociceptive non‐cancer pain were included (September 2013 to May 2017) and followed for six months. The primary outcome was the pain intensity difference (by visual analog scale score) between month 3 and baseline. The secondary outcomes, assessed at months 3 and 6, were SF36 score, analgesics consumption and number of TENS sessions performed at home (last seven days). Results: Seventy‐two patients were included, suffering from a combination of chronic non‐cancer nociceptive and neuropathic pain, with a mean pain intensity of about sixty out of a hundred. The results show an important pain reduction (forty percent) in both groups at 3 months. No significant difference was observed between the control and intervention groups. Similarly, SF36 score, change in analgesic intake and patient compliance did not differ significantly between groups. Conclusions: This is the first randomized controlled study showing a decrease of pain intensity and a high level of compliance with transcutaneous electrical nerve stimulation alone or associated to hypnosis. The combination does not seem to be more efficient than transcutaneous electrical nerve stimulation alone. Chronic non‐cancer pain remains a major issue and a substantial proportion of patients do not appear to benefit from interventions. Impact: This study increases our understanding of the combination of two non‐pharmacological methods in chronic non‐cancer pain patients. The combination of the two non‐pharmacological strategies did not appear to be more efficient than one alone. Further research on non‐pharmacological treatments targeting to patient's characteristics are needed to find appropriate strategies in patients with complex multidimensional pain conditions. Clinical Trial Number: NCT01944150 (Sept. 17, 2013). [ABSTRACT FROM AUTHOR]

To evaluate and compare the effectiveness and quality of standard face-to-face and teleaudiology hearing aid fitting follow-up consultations and blended services for adult hearing aid users. Fifty-six participants were randomly allocated to two equal groups, with equal numbers of new and experienced users. One standard and one teleaudiology follow-up consultation were delivered by an audiologist, the latter assisted by a facilitator. The order was reversed for the second group. Outcome measurement tools were applied to assess aspects of participants' communication, fitting (physical, sensorial), quality of life, and service. Cross-sectional and longitudinal outcomes were analysed. Most participants presented with moderate, sloping, and symmetrical sensorineural hearing loss. The duration of teleaudiology (42.96 ± 2.73 min) was equivalent to face-to-face consultations (41.25 ± 2.61 min). All modes of service delivery significantly improved outcomes for communication, fitting, and quality of life (p > 0.05). Satisfaction for both consultation modes was high, although significantly greater with standard consultations. The mode and order of delivery of the consultations did not influence the outcomes. Teleaudiology hearing aid follow-up consultations can deliver significant improvements, and do not differ from standard consultations. Blended services also deliver significant improvements. Satisfaction can be negatively impacted by technical or human-related issues. [ABSTRACT FROM AUTHOR]

Purpose: The current study developed a strength-based flourishing intervention (SFI) and examined its efficacy on fostering the resilience of people with physical disabilities in poor areas, using a randomized (1:1) parallel-group controlled, and single-blind trial. Method: A total of 51 participants (M age = 42.16, standard deviation = 8.42; 43.14% males; 29 for the intervention group, whereas 22 for the control group) completed preintervention, postintervention, and 3-month follow-up tests. Results: The 2 × 3 mixed repeated measure analyses and post hoc analyses revealed a significant main group effect (F = 4.46, p =.04) and a short-term effect (i.e., 3 month; F = 6.35, p =.02) of the SFI. The results indicated that the SFI could significantly promote resilience in the intervention group. However, the effects of the intervention did not immediately appear. Discussion: The SFI could assist in providing research-based and cost-effective health services to promote flourishing and resilience in vulnerable populations. [ABSTRACT FROM AUTHOR]

Purpose: To compare family and functional outcome in infants at very high risk of cerebral palsy, after receiving the family centred programme "Coping with and Caring for infants with special needs (COPCA)" or typical infant physiotherapy. Materials and methods: Forty-three infants at very high risk were included before 9 months corrected age and randomly assigned to one year COPCA (n = 23) or typical infant physiotherapy (n = 20). Family and infant outcome were assessed before and during the intervention. Physiotherapy intervention sessions were analysed quantitatively for process analysis. Outcome was evaluated with non-parametric tests and linear mixed-effect models. Results: Between-group comparisons revealed no differences in family and infant outcomes. Within-group analysis showed that family's quality of life improved over time in the COPCA-group. Family empowerment was positively associated with intervention elements, including "caregiver coaching." Conclusions: One year of COPCA or typical infant physiotherapy resulted in similar family and functional outcomes. Yet, specific intervention elements, e.g., coaching, may increase empowerment of families of very high risk infants and may influence quality of life, which emphasizes the importance of family centred services. One year of the family centred programme "Coping with and a Caring for infants with special needs" compared with typical infant physiotherapy resulted in similar family outcome and similar functional outcome for the infants at very high risk for cerebral palsy. Specific contents of intervention, such as caregiver coaching, are associated with more family empowerment and increased quality of life. Emphasis on family needs is important in early intervention for infants at very high risk for cerebral palsy. [ABSTRACT FROM AUTHOR]