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To examine individual- and environmental-level factors associated with perceived participation performance and satisfaction in people with chronic stroke.Cross-sectional study using secondary data analysis of baseline data from a randomized controlled trial.Community-based setting.Community-dwelling adults with mild to moderate stroke (N=113; mean age=57 years; 58 males).Not applicable.Main outcomes were measured with the Reintegration to Normal Living Index (perceived participation performance) and Patient-Reported Outcome Measure Information System satisfaction with participation in social roles (perceived participation satisfaction). Other variables collected included personal (eg, age, perceived recovery), health-related (eg, time since stroke, number of comorbidities), body function-related (eg, Stroke Impact Scale, Center for Epidemiologic Studies Depression Scale), and environmental (eg, World Health Organization Quality of Life Short Form Environmental subscale) data.Depression, fatigue, mobility, and environmental support showed moderate to strong, statistically significant associations with participation performance and satisfaction in people with stroke. Perceived recovery was moderately associated with participation performance but not with participation satisfaction.Returning to participation is a complex process after stroke. Results suggest that various personal, body function-related, and environmental factors are associated with participation performance and satisfaction.

Physical activity is important to prevent and manage multiple chronic medical conditions. The objective of this study was to describe the implementation of a physical activity vital sign (PAVS) in a primary care setting and examine the association between physical activity with demographic characteristics and chronic disease burden.We extracted data from the electronic medical records of patients who had visits from July 2018 through January 2020 in a primary care clinic in which PAVS was implemented as part of the intake process. Data collected included self-reported physical activity, age, sex, body mass index, race, ethnicity, and a modified Charlson Comorbidity Index score indicating chronic disease burden. We classified PAVS into 3 categories of time spent in moderate to strenuous intensity physical activity: consistently inactive (0 min/wk), inconsistently active (150 min/wk), and consistently active (≥150 min/wk). We used χDuring the study period, 13,704 visits, corresponding to 8,741 unique adult patients, had PAVS recorded. Overall, 18.1% of patients reported being consistently inactive, 48.3% inconsistently active, and 33.7% consistently active. All assessed demographic and clinical covariates were associated with PAVS classification (all P.001). Larger percentages of consistent inactivity were reported for female, older, and underweight or obese patients. Larger percentages of consistent activity were reported for male, younger, and normal weight or overweight patients.Using PAVS as a screening tool in primary care enables physicians to understand the physical activity status of their patients and can be useful in identifying inactive patients who may benefit from physical activity counseling.

Background/objective After wearing powdered gloves, healthcare workers (HCW) are supposed to wash their hands instead of using alcohol-based hand-rub (ABHR). Washing hands takes longer than using ABHR, and the use of powdered gloves may be an obstacle to hand-hygiene compliance. This study aimed to evaluate the impact of replacing powdered gloves with powder-free gloves on hand-hygiene compliance among HCW of an intensive care unit (ICU). Methods A quasi-experimental study was conducted in a general ICU of a tertiary care university hospital in Brazil. From June 1st to July 15th, 2017, all HCW were provided with powdered latex gloves only for all clinical procedures. From July 15th to August 31st, 2017, HCW were provided with nitrile powder-free gloves only. Hand-hygiene compliance was assessed through direct observation, and evaluated according to the World Health Organization Hand Hygiene guidelines. We calculated that a sample size of 544 hand hygiene opportunities needed to be observed per period. Data analysis were performed using the STATA SE® version 14, and we compared the individual’s percentage of compliance using the t test for paired data before and after the intervention. Results Overall, 40 HCW were assessed before and after the introduction of nitrile powder-free gloves, with 1114 and 1139 observations of hand hygiene opportunities, respectively. The proportion of compliance with hand hygiene was 55% (95% confidence interval [CI] 51–59%) using powdered latex gloves and 60% (95% CI 57–63%) using powder-free gloves. The difference in proportions between the two types of gloves was 5.1% (95% CI 2.5–7.6%, p Conclusion Our data indicate that replacing powdered gloves with powder-free gloves positively influenced hand-hygiene compliance by HCW in an ICU setting.

Chronic pain is a significant health problem worldwide with limited pharmacological treatment options. This study evaluated the relative efficacy of 4 treatment sessions each of 4 nonpharmacological treatments: (1) hypnotic cognitive therapy (using hypnosis to alter the meaning of pain); (2) standard cognitive therapy; (3) hypnosis focused on pain reduction, and (4) pain education. One hundred seventy-three individuals with chronic pain were randomly assigned to receive 4 sessions of 1 of the 4 treatments. Primary (pain intensity) and secondary outcome measures were administered by assessors unaware of treatment allocation at pretreatment, posttreatment, and 3-, 6-, and 12-month follow-up. Treatment effects were evaluated using analysis of variance, a generalized estimating equation approach, or a Fisher exact test, depending on the outcome domain examined. All 4 treatments were associated with medium to large effect size improvements in pain intensity that maintained up to 12 months posttreatment. Pretreatment to posttreatment improvements were observed across the 4 treatment conditions on the secondary outcomes of pain interference and depressive symptoms, with some return towards pretreatment levels at 12-month follow-up. No significant between-group differences emerged in omnibus analyses, and few statistically significant between-group differences emerged in the planned pairwise analyses, although the 2 significant effects that did emerge favored hypnotic cognitive therapy. Future research is needed to determine whether the significant differences that emerged are reliable.

Aims and objectives To compare mentholated popsicle with usual care (absolute fasting) in the change of thirst intensity and discomfort of patients in the preoperative fasting. Background Thirst is defined as the desire to drink water, and it is considered to be a multifactorial symptom. In the preoperative fasting, the patient may experience intense thirst, often for a long time, that can lead to feelings of suffocation, desperation, fear and anxiety. Design A randomised controlled trial. Methods Forty patients, aged between 18-60 years, were randomised to mentholated popsicle group or absolute fasting group (twenty in each). The primary outcomes were thirst intensity, evaluated by a numeric scale ranging from 0 (no thirst)-10 (the worst possible thirst), and discomfort from thirst (evaluated by the Perioperative Thirst Discomfort Scale), both measured twice (baseline and after 20 min of intervention). The CONSORT checklist was used to report this study. Results Mean age was similar in both groups (38 years in the mentholated popsicle group and 39 in the absolute fasting group). At baseline, the mentholated popsicle group had higher median for the scales of intensity (6.5) and discomfort (7.5) from thirst than the absolute fasting group (5.0 and 5.0, respectively). At the end of 20 min, the popsicle group had a statistically significant decrease in intensity and discomfort from thirst (median decreases of 5.0 and 7.0 points, respectively) when compared to the absolute fasting group (median increases of 0.5 and 1.0 points, respectively). Conclusions The use of mentholated popsicle decreased the intensity and discomfort from thirst, and it is a viable strategy for the management of thirst in the preoperative fasting. Relevance to clinical practice In the preoperative fasting, making mentholated popsicles available to patients is an easy strategy to manage thirst, which might lead to better care.

The purpose of this research was to pursue an innovative cyclic panel-pull strategy during ambulation to minimize limb fluid volume loss in transtibial prosthesis users. Participants' traditional socket shapes were duplicated, and test sockets prepared with three adjustable motor-driven panels that were controlled by a microprocessor. After donning the prosthesis, participants' liners were fastened to the panels. During a 40 min test session, participants conducted three cycles of sitting (5 min) and walking (8 min). During the 5th and 6th min of each cycle of walking, the panels were cyclically pulled outward in late stance phase, decreasing pressure on the residual limb. Panels were returned to their original position in swing phase. Eight of twelve participants gained more fluid volume while walking when panel-pull was added than when it was removed. When the liner was uncoupled from the panels and panel-pull was executed, eight of twelve participants gained less fluid volume compared to when the liner was fastened to the panels. Panel-pull may facilitate limb fluid volume retention in transtibial prosthesis users. Efforts to simplify the design so that it can be implemented in long-term testing during at-home use should be considered.

Effective, rigorously evaluated nonpharmacological treatments for chronic pain are needed. This study compared the effectiveness of training in hypnosis (HYP) and mindfulness meditation (MM) with an active education control (ED). Veterans (N = 328) were randomly assigned to 8 manualized, group-based, in-person sessions of HYP (n = 110), MM (n = 108), or ED (n = 110). Primary (average pain intensity [API]) and secondary outcomes were assessed at pretreatment, posttreatment, and 3 and 6 months posttreatment. Treatment effects were evaluated using linear regression, a generalized estimating equation approach, or a Fisher exact test, depending on the variable. There were no significant omnibus between-group differences in pretreatment to posttreatment change in API; however, pretreatment to posttreatment improvements in API and several secondary variables were seen for participants in all 3 conditions. Participation in MM resulted in greater decreases in API and pain interference at 6 months posttreatment relative to ED. Participation in HYP resulted in greater decreases in API, pain interference, and depressive symptoms at 3 and 6 months posttreatment compared with ED. No significant differences on outcomes between HYP and MM were detected at any time point. This study suggests that all 3 interventions provide posttreatment benefits on a range of outcomes, but the benefits of HYP and MM continue beyond the end of treatment, while the improvements associated with ED dissipate over time. Future research is needed to determine whether the between-group differences that emerged posttreatment are reliable, whether there are benefits of combining treatments, and to explore moderating and mediating factors.

The current study used data from a clinical trial to identify variables that are associated with and/or mediate the beneficial effects of 4 psychological chronic pain treatments: one teaching patients self-hypnosis to reduce pain intensity (HYP), one teaching self-hypnosis to change thoughts about pain (hypnotic cognitive therapy [HYP-CT]), one teaching cognitive restructuring skills to change thoughts about pain (cognitive therapy [CT]), and one providing education about pain (ED; included as an active control condition). Of 17 possible mechanism variables examined, and with alpha not corrected for multiple comparisons, significant between-group differences were observed for 3. Two of these (changes in beliefs about control over pain and number of days of skill practice) were supported as mediators of the beneficial effects of HYP, CT, or HYP-CT, relative to ED. Six mechanism variables evidenced significant pretreatment to post-treatment changes in the sample as a whole, without showing significant between-group differences. Pretreatment to post-treatment changes in all 6 were associated with improvements in pain interference, pain intensity, or both. In addition, participant ratings of therapeutic alliance at post-treatment were associated significantly with improvements in both pain intensity and pain interference in the sample as a whole. Thus, of the 17 possible mediators examined, there were relatively few that served as mediators for the beneficial effects of specific treatments; a larger number of variables predicted treatment outcome overall. The extent to which these variables are treatment mediators (ie, are responsible for, rather than merely associated with, treatment-related improvements) will require further research.

An understanding of early-onset mechanisms underlying age-related changes can be obtained by evaluating changes that precede frailty and end of life using histological characterization of age-related lesions. Histopathology-based information as a component of aging studies in mice can complement and add context to molecular, cellular, and physiologic data, but there is a lack of information regarding scoring criteria and lesion grading guidelines. This report describes the validation of a grading system, designated as the geropathology grading platform (GGP), which generated a composite lesion score (CLS) for comparison of histological lesion scores in tissues from aging mice. To assess reproducibility of the scoring system, multiple veterinary pathologists independently scored the same slides from the heart, lung, liver, and kidney from two different strains (C57BL/6 and CB6F1) of male mice at 8, 16, 24, and 32 months of age. There was moderate to high agreement between pathologists, particularly when agreement within a 1-point range was considered. CLS for all organs was significantly higher in older versus younger mice, suggesting that the GGP was reliable for detecting age-related pathology in mice. The overall results suggest that the GGP guidelines reliably distinguish between younger and older mice and may therefore be accurate in distinguishing between experimental groups of mice with more, or less, age-related pathology.

BACKGROUND: Loss of residual limb volume degrades socket fit and may require accommodation. OBJECTIVES: To examine if either of two accommodation strategies executed during resting, socket release with full socket size return and socket release with partial socket size return, enhanced limb fluid volume retention during subsequent activity. STUDY DESIGN: Two repeated-measures experiments were conducted to assess the effects of socket release on limb fluid volume retention. METHODS: Limb fluid volume was monitored while participants wore a socket with a single adjustable panel. Participants performed eight activity cycles that each included 10 minutes of sitting and 2 minutes of walking. The socket’s posterior panel and pin lock were released during the 5(th) cycle while participants were sitting. In one experiment (Full Return), the socket was returned to its pre-release size; in a second experiment (Partial Return), it was returned to 102% of its pre-release size. Short-term and long-term limb fluid volume retention were calculated and compared to a projected, No Intervention condition. RESULTS: Partial Return and Full Return short-term retentions and Partial Return long-term retention were greater than those projected under the control condition (p

Objectives To evaluate the effect of reinforcing an educational programme through telephone follow-up on health-related quality of life and anxiety and depression symptoms in individuals starting warfarin therapy. Background Educational interventions have improved quality of life in individuals using warfarin. Few studies have examined the addition of telephone follow-up to enhance educational interventions. Design Randomised controlled trial in outpatient setting. Methods Hospitalised adults starting warfarin therapy who agreed to participate received an educational programme about the warfarin treatment. At discharge, they were randomised to receive either five telephone follow-up calls (intervention) or no telephone calls (controls). Both groups were evaluated for health-related quality of life (using Duke Anticoagulation Satisfaction Scale) and symptoms of anxiety and depression (using Hospital Anxiety and Depression Scale) at three and six months post-discharge. Groups were compared at each time by independent-samples t test, and over time by repeated-measures analysis of variance, with time (three and six months), groups (intervention and control) and an interaction between time and group as factors. Level of significance was set at 0.05. The Consolidated Standards of Reporting Trials was used for reporting. Results Fifty-two individuals (26 per group) completed the study. There were no statistical differences between groups in health-related quality of life, anxiety and depression symptoms, at both times post-discharge. Participants who received follow-up telephone calls reported better positive psychological impact (a subscale of quality of life) than controls. Conclusions Reinforcing an educational programme with telephone follow-ups did not have an overall effect on health-related quality of life of individuals using warfarin but promoted positive psychological impact. Relevance to clinical practice The low cost of reinforcing educational programmes with telephone calls and the improvement in positive psychological aspects indicate that this type of intervention is still a promising intervention that could be further investigated and improved.

The major aim of this randomized, placebo-controlled, triple-blind clinical trial was to evaluate the efficacy of cinnamon as an adjuvant treatment in reducing glycemic levels in people with type 2 diabetes, compared to a placebo. The study was conducted between August and December 2019, with 160 people with type 2 diabetes, in five Primary Health Units, in Parnaíba, Brazil. Inclusion criteria were: persons of both genders using oral antidiabetic agents, with glycated hemoglobin ≥ 6.0%, and between 18 and 80 years of age. The primary outcome was change in glycated hemoglobin levels after 90 days of intervention. Other biomarkers evaluated were fasting blood glucose, insulin level, and HOMA-IR index. Participants were divided equally into two groups of 80 individuals each, and were given 3 g capsules of either cinnamon or placebo to be taken in combination with their usual oral antidiabetic agents. After 90 days, participants in the cinnamon group had statistically significant reductions of 0.2% of glycated hemoglobin and 0.55 mmol/L of fasting venous glucose, when compared with the placebo group. Cinnamon reduced the glycemic measures of persons with type 2 diabetes, albeit with modest reductions. TRIAL: RBR-2KKB6D.

Objective: To estimate the incidence and distribution of the degree of radiodermatitis in cancer patients submitted to radiotherapy in the regions of head and neck, breast, and pelvis. Method: Prospective, longitudinal, quantitative study conducted from March 15, 2016 to May 4, 2017 with patients observed for five weeks of treatment. The primary outcome was the proportion of grade 1 or higher radiodermatitis each week. The degree of radiodermatitis and mean time of occurrence for each patient were secondary outcomes. Results: This study included 112 patients. The incidence of radiodermatitis was 100% among those whose head and neck region was irradiated, followed by 98% for breast and 48% for the pelvic region. The degree of radiodermatitis varied with the irradiated site; the worst degrees were found in the head and neck region, followed by the breast. In the three groups, the mean time of the first occurrence of radiodermatitis was approximately eleven days. Conclusion: The incidence of radiodermatitis in the studied groups was high, which reinforces the need to perform the same evaluation nationwide. This would support creating and standardizing protocols and recommendations for a proper management of radiodermatitis, specially concerning its prevention. RESUMEN Objetivo: Estimar la incidencia y la distribución del grado de radiodermatitis en pacientes con cáncer sometidos a radioterapia en las regiones de la cabeza y el cuello, la mama y la pelvis. Método: Estudio prospectivo, longitudinal y cuantitativo realizado entre el 15 de marzo de 2016 y el 4 de mayo de 2017 con pacientes observados durante cinco semanas de tratamiento. El resultado primario fue la proporción de radiodermatitis grado 1 o superior cada semana. El grado de radiodermatitis y el tiempo medio de la primera aparición en cada paciente fueron resultados secundarios. Resultados: Participaron 112 pacientes. La incidencia de radiodermatitis fue del 100% entre los que se irradiaron en la región de la cabeza y el cuello, seguida del 98% en la mama y el 48% en la pelvis. El grado de radiodermatitis variaba según el sitio de irradiación, con peores grados en la región de la cabeza y el cuello, seguida de la mama. En los tres grupos, el tiempo medio para la primera aparición de radiodermatitis fue de aproximadamente 11 días. Conclusión: La incidencia de la radiodermatitis fue elevada en los grupos estudiados, lo que reitera la necesidad de hacer la misma evaluación en todo el país. Esta evaluación fomentaría la creación y la uniformización de los protocolos y recomendaciones para el manejo adecuado de la radiodermatitis, especialmente en lo que respecta a su prevención. RESUMO Objetivo: Estimar a incidência e a distribuição de graduação de radiodermatite em pacientes com câncer submetidos à radioterapia nas regiões de cabeça e pescoço, mama e pelve. Método: Estudo prospectivo, longitudinal, quantitativo, realizado durante o período de 15 de março de 2016 a 4 de maio de 2017 com pacientes observados ao longo de cinco semanas de tratamento. O desfecho primário foi proporção de radiodermatite grau 1 ou superior em cada semana. Graduação de radiodermatite e tempo médio para a primeira ocorrência em cada paciente foram desfechos secundários. Resultados: Participaram 112 pacientes. A incidência de radiodermatite foi de 100% entre os que irradiaram a região de cabeça e pescoço, seguida por 98% em mama e 48% na pelve. A graduação de radiodermatite variou de acordo com o local da irradiação, com piores graduações na região de cabeça e pescoço, seguida por mama. Nos três grupos, o tempo médio para a primeira ocorrência de radiodermatite foi de aproximadamente 11 dias. Conclusão: A incidência de radiodermatite foi alta nos grupos estudados, o que reitera a necessidade de se fazer a mesma avaliação em âmbito nacional. Essa avaliação incentivaria a criação e a uniformização de protocolos e recomendações para o manejo adequado da radiodermatite, principalmente no que concerne à sua prevenção.

We assessed safety and potential efficacy of a chamomile gel compared with urea cream to prevent acute radiation dermatitis in head and neck cancer patients. We assessed safety and potential efficacy of the chamomile gel in escalating concentrations of 2.50%, 5.00% and 8.35% of chamomile. Concentration of 8.35% was chosen for a randomized trial comparing chamomile gel (8.35%) with urea cream (n = 24 per group), for potential efficacy to delay or prevent radiation dermatitis in these patients. Preliminary results demonstrate a delayed onset of dermatitis, with onset of Grade 2 dermatitis at 5.1 (1.3) weeks in the chamomile group and 4.5 (1.3) weeks in the urea group (effect size of 0.46). Itching, burning and hyperpigmentation were more frequently reported in the urea group. Results indicates a potential efficacy of the chamomile gel. Further studies are needed to confirm the effect of the chamomile gel in reducing or delaying the occurrence of radiation dermatitis.

IntroductionA challenge in the engineering of auto-adjusting prosthetic sockets is to maintain stable operation of the control system while users change their bodily position and activity. The purpose of this study was to test the stability of a socket that automatically adjusted socket size to maintain fit. Socket release during sitting was conducted between bouts of walking.MethodsAdjustable sockets with sensors that monitored distance between the liner and socket were fabricated. Motor-driven panels and a microprocessor-based control system adjusted socket size during walking to maintain a target sensed distance. Limb fluid volume was recorded continuously. During eight sit/walk cycles, the socket panels were released upon sitting and then returned to position for walking, either the size at the end of the prior bout or a size 1.0% larger in volume.ResultsIn six transtibial prosthesis users, the control system maintained stable operation and did not saturate (move to and remain at the end of the actuator’s range) during 98% of the walking bouts. Limb fluid volume changes generally matched the panel position changes executed by the control system.ConclusionsStable operation of the control system suggests that the auto-adjusting socket is ready for testing in users’ at-home settings.

BackgroundChronic pain is one of the most prevalent and disabling symptoms associated with multiple sclerosis (MS). Individuals with MS are interested in nonpharmacologic pain management approaches. Cognitive-behavioral therapy (CBT) is efficacious in improving MS-related pain outcomes. Mindfulness-based cognitive therapy (MBCT) is a promising, alternative approach. Little is known about moderators of these treatments’ outcomes, however. This article describes the study protocol for the first randomized controlled trial comparing MBCT, CBT, and usual care and examining treatment effect moderators in individuals with chronic pain and MS.MethodsWe will conduct a single-center, randomized, single blind, parallel-group trial comparing MBCT, CBT, and usual care in adults with MS and chronic pain. Both interventions will be delivered via eight group sessions using videoconferencing technology. Primary (average pain intensity) and secondary outcomes (including pain interference, depressive symptoms, fatigue, and sleep) will be assessed pre-treatment, mid-treatment, post-treatment, and at 6-month follow up. Potential treatment moderators will be assessed pre-treatment. We hypothesize that participants randomly assigned to MBCT or CBT will report significantly greater reductions in average pain intensity than participants assigned to usual care at post-treatment (primary study endpoint) and 6-month follow up. We also hypothesize that mindfulness, pain catastrophizing, and behavioral activation pre-treatment will moderate response to both active treatments, but not response to usual care.DiscussionFindings will provide important new information about the efficacy and moderators of two nonpharmacologic pain management approaches delivered using technology to overcome common barriers to treatment access. The knowledge gained may lead to better patient-treatment matching and, ultimately, better pain treatment outcomes in MS.Trial registrationClinicalTrials.gov,NCT03782246. Registered on 20 December 2018.

The purposes were to examine construct validity of the Motor Planning Maze Assessment (Maze) and three items from the Functional Gait Assessment (FGA) that were modified for children (pediatric modified FGA, pmFGA), by comparing performance of children with DCD and age matched peers with typical development (TD); the construct validity of total scores of the Dynamic Gait Index (DGI) and the FGA.Twenty pairs of children with DCD and TD, age from 5 to 12 years, participated in this study. Children in both groups were tested on the Maze, pmFGA, DGI, and FGA. Paired t-tests and agreement tables were used to compare the motor performances between two groups.The DCD group showed higher summary scores in the Maze (p0.001) and demonstrated significantly fewer steps (p ≤ 0.001) while doing the pmFGA items than the TD group. However, the FGA quality scores demonstrated minimal differences between the two groups on all three items. Children with DCD showed significantly lower DGI and FGA total scores (p0.001) than the TD group.The Maze, DGI, and FGA tests are easily applied in clinical settings and can differentiate motor planning and gait coordination between children with DCD and with TD.

Background and objectives Evidence-based pharmacological and behavioral interventions are often underutilized or inaccessible to persons with multiple sclerosis (MS) who have chronic pain and/or depression. Collaborative care is an evidence-based patient-centered, integrated, system-level approach to improving the quality and outcomes of depression care. We describe the development of and randomized controlled trial testing a novel intervention, MS Care , which uses a collaborative care model to improve the care of depression and chronic pain in a MS specialty care setting. Methods We describe a 16-week randomized controlled trial comparing the MS Care collaborative care intervention to usual care in an outpatient MS specialty center. Eligible participants with chronic pain of at least moderate intensity (≥ 3/10) and/or major depressive disorder are randomly assigned to MS Care or usual care. MS Care utilizes a care manager to implement and coordinate guideline-based medical and behavioral treatments with the patient, clinic providers, and pain/depression treatment experts. We will compare outcomes at post-treatment and 6-month follow up. Projected patient outcomes We hypothesize that participants randomly assigned to MS Care will demonstrate significantly greater control of both pain and depression at post-treatment (primary endpoint) relative to those assigned to usual care. Secondary analyses will examine quality of care, patient satisfaction, adherence to MS care, and quality of life. Study findings will aid patients, clinicians, healthcare system leaders, and policy makers in making decisions about effective care for pain and depression in MS healthcare systems. (PCORI- IH-1304-6379; clinicaltrials.gov : NCT02137044 ). This trial is registered at ClinicalTrials.gov , protocol NCT02137044 .

Moderate to severe traumatic brain injury (TBI) is a common cause of long-term disability. Due to challenges that include inconsistent access to follow-up care, persons with TBI being discharged from inpatient rehabilitation facilities (IRFs) are at risk for rehospitalization, poor reintegration into the community, family stress, and other unfavorable outcomes resulting from unmet needs. In a six-center randomized pragmatic comparative effectiveness study, the BRITE trial (Brain Injury Rehabilitation: Improving the Transition Experience, ClinicalTrials.gov NCT03422276 ), we compare the effectiveness of two existing methods for transition from IRF to community living or long-term nursing care. The Rehabilitation Discharge Plan (RDP) includes patient/family education and referrals for continued care. The Rehabilitation Transition Plan (RTP) provides RDP plus individualized, manualized care management via phone or videoconference, for 6 months. Nine hundred patients will be randomized (1:1) to RDP or RTP, with caregivers also invited to participate and contribute caregiver-reported outcomes. Extensive stakeholder input, including active participation of persons with TBI and their families, has informed all aspects of trial design and implementation planning. We hypothesize that RTP will result in better patient- and caregiver-reported outcomes (societal participation, quality of life, caregiver well-being) and more efficient use of healthcare resources at 6-months (primary outcome) and 12-months post-discharge, compared to RDP alone. Planned analyses will explore which participants benefit most from each transition model. With few exclusion criteria and other pragmatic features, the findings of this trial are expected to have a broad impact on improving transitions from inpatient TBI rehabilitation. Trial registration ClinicalTrials.gov identifier NCT03422276

Chronic health conditions of the elderly lead to limitations in physical activity with disability, anxiety, and increased need for medical care and assisted living conditions. Physical performance tests are used to screen for pending loss of mobility and can serve as endpoints to monitor the effectiveness of intervention measures. Since limited mobility is associated with the physical and mental health of a person, evaluation of this in preclinical aging studies in mice will provide a translational approach for testing new intervention strategies. We assessed physiological parameters in 4, 12, 20 and 28 month old C57BL/6 and CB6F1 male mice using a rotating rod, a free running wheel, and a photo beam activity field, designed to determine changes in coordinated walking ability, self-motivated running distance, and anxiety response to a novel environment, respectively. Older mice showed decreased coordinated walking times and decreased running distances, predictive of physical performance ability and motivation in the elderly. Changes in both lateral and vertical movements were observed in a novel cage environment suggesting different levels of anxiety. Because the genetic background of the two mouse strains influenced test results in an age-dependent manner, it is imperative to recognize that diverse genetic backgrounds in mice may yield different data in preclinical studies and would need to be interpreted individually for translational applications.

PURPOSE To examine the effects of Sensorimotor Training to Affect Balance, Engagement, and Learning (STABEL), a virtual reality system to train sensory adaptation for balance control, for children with fetal alcohol spectrum disorders (FASDs). METHODS Twenty-three children with FASDs received STABEL training in a university laboratory, or home, or were controls. The Movement Assessment Battery for Children-2nd edition (MABC-2) and Pediatric Clinical Test of Sensory Interaction for Balance-2 (P-CTSIB-2) were analyzed by group (lab, home, and control), session (pre-STABEL, 1 week post-STABEL, and 1 month post-STABEL), and group-by-session interaction. RESULTS Significant effects were group and session for MABC-2 Balance and interaction for MABC-2 Total Motor and P-CTSIB-2. CONCLUSION Preliminary results support improved sensory adaptation, balance, and motor performance post-STABEL, which warrant further study with a larger, randomized sample.

Background Conservative treatment for carpal tunnel syndrome (CTS) often includes wrist orthosis. However, there is no consensus on whether commercial or custom-made wrist orthosis is better for the treatment. Purpose To assess feasibility of a study comparing nocturnal use of commercial versus custom-made wrist orthosis in the treatment of mild/moderate CTS and estimate their potential effects on function and symptoms. Study design Randomized clinical trial. Methods Twenty-four individuals with mild/moderate CTS were randomized to wear either a commercial orthosis (n = 12) or a custom-made orthosis (n = 12). Participants used the assigned orthosis at night for 45 days and performed gliding exercises at home/work. We collected data on access to eligible population and feasibility of protocol. Data on use of orthosis, performance of exercises, and symptoms were collected through a dairy filled by the participant. Outcomes were pain (using Numeric Pain Rating Scale), symptom severity and functional status (using Boston Questionnaire), pinch strength (by dynamometry), and electromyographic activity of forearm muscles (sampled during a reach-to-grasp task). Outcomes were measured before and after the intervention. Results There were no loses to follow-up in either intervention group. After treatment, we found increased tripod pinch strength and better symptoms and function in both orthosis groups, with better outcomes for the custom-made orthosis, although the differences were not statistically significant. Conclusions The preliminary results showed a potential for better outcomes from the custom-made orthosis. We established that a larger study would be feasible and could be designed and conducted based on the estimates provided by this study. Trial registration Brazilian Registry of Clinical Trials (ReBEC) – registration number: RBR-74rqnz.

Vieira, KVSG, Ciol, MA, Azevedo, PH, Pinfildi, CE, Renno, ACM, Colantonio, E, and Tucci, HT. Effects of light-emitting diode therapy on the performance of biceps brachii muscle of young healthy males after 8 weeks of strength training: a randomized controlled clinical trial. J Strength Cond Res 33(2): 433-442, 2019-We assessed the effect of adding light-emitting diode therapy (LEDT) to an 8-week strength training of biceps brachii in healthy young males. Forty-five participants were randomized into training plus LEDT, training plus sham LEDT, and control groups (n = 15 each). Individuals in the LEDT groups participated in strength training performed in a Scott machine at their maximum number of elbow flexion-extension repetitions. The LEDT was applied to biceps brachii of dominant limb at the end of training sessions (device "on" for LEDT and "off" for sham LEDT). Training loads were re-evaluated every 2 weeks. Controls did not receive training during 8 weeks. All groups were evaluated for 1 repetition maximum (1RM) and fatigue at baseline and 8 weeks. Additionally, the 2 LEDT groups were evaluated every 2 weeks for 1-RM and number of elbow flexion-extension repetitions. The groups were statistically different in mean difference and mean percent change of 1-RM from baseline to week 8 (p < 0.001). Analyzing the 2 LEDT groups, we found an interaction between group and time (p = 0.02), with a slightly faster increase in 1-RM for the LEDT than the sham LEDT. Over time, both groups decreased the number of repetitions of elbow flexion-extension (differences not statistically significant), possibly because of the increase of load over time. We found no difference in change of fatigue index among the 3 groups. Our study showed potential benefits to 1RM when LEDT is applied after a strength training session. Future studies might assess whether different doses of LEDT can reduce fatigue in strength training.

Background The World Health Organization (WHO) ethanol-based handrub (EBHR) formulation contains 1.45% glycerol as an emollient to protect healthcare workers’ (HCWs) skin against dryness and dermatitis. However, glycerol seems to negatively affect the antimicrobial efficacy of alcohols. In addition, the minimal concentration of glycerol required to protect hands remain unknown. We aim to evaluate the tolerance of HCWs to the WHO EBHR formulation using different concentrations of glycerol in a tropical climate healthcare setting. Methods We conducted a cluster-randomized, double-blind, crossover study among 40 HCWs from an intensive care unit of a tertiary-care hospital in Brazil, from June 1st to September 30, 2017. We tested the WHO EBHR original formulation containing 1.45% glycerol against three other concentrations (0, 0.5, and 0.75%). HCWs used one formulation at a time for seven working days during their routine practice and then had their hands evaluated by an external observer using the WHO scale for visual inspection. Participants also used a WHO self-evaluation tool to rate their own skin condition. We used a generalized estimating equations of the logit type to compare differences between the tolerability to different formulations. Results According to the independent observation, participants had 2.4 times (95%CI: 1.12–5.15) more chance of having a skin condition considered good when they used the 0.5% compared to the 1.45% glycerol formulation. For the self-evaluation scale, participants were likely to have a worst evaluation (OR: 0.23, 95%CI: 0.11–0.49) when they used the preparation without glycerol compared to the WHO standard formulation (1.45%), and there were no differences between the other formulations used. Conclusion In a tropical climate setting, the WHO-modified EBHR formulation containing 0.5% glycerol led to better ratings of skin tolerance than the original formulation, and, therefore, may offer the best balance between skin tolerance and antimicrobial efficacy.

Objective: to estimate the effects of non-pharmacological interventions to improve the quality of sleep and quality of life of patients with heart failure. Method: pilot study of a randomized controlled trial with 32 individuals assigned to four groups. Sleep was assessed using the Pittsburgh Sleep Quality Inventory, while health-related quality of life was assessed using the Minnesota Living with Heart Failure Questionnaire, at the baseline and at the 12th and 24th weeks. The means of the outcomes according to intervention groups were compared using analysis of covariance; effect sizes were calculated per group. Results: all groups experienced improved quality of sleep and health-related quality of life at the end of the intervention (week 12) and at follow-up (week 24), though differences were not statistically significant (p between 0.22 and 0.40). The effects of the interventions at the 12th week ranged between -2.1 and -3.8 for the quality of sleep and between -0.8 and -1.7 for quality of life, with similar values at the 24th week. Conclusion: the effects found in this study provide information for sample size calculations and statistical power for confirmatory studies. Brazilian Clinical Trials Registry - RBR 7jd2mm RESUMO Objetivo: estimar os efeitos de intervenções não farmacológicas para melhora da qualidade de sono e de vida de pacientes com insuficiência cardíaca. Método: estudo piloto de um ensaio controlado aleatorizado com 32 indivíduos alocados em quatro grupos. Sono foi avaliado pelo Pittsburgh Sleep Quality Inventory e qualidade de vida relacionada à saúde avaliada pelo Minnessota Living with Heart Failure Questionnaire, no início e nas semanas 12 e 24 do estudo. As médias dos desfechos por grupo de intervenção foram comparadas por análise de covariância, e os tamanhos dos efeitos calculados para cada grupo. Resultados: todos os grupos apresentaram melhora na qualidade de sono e de vida relacionada à saúde no final do período de intervenção (12 semanas) e no seguimento de 24 semanas, mas as diferenças não foram estatisticamente significantes (p entre 0,22 e 0,40). Em 12 semanas, os efeitos das intervenções variaram entre -2,1 e -3,8 na qualidade de sono e de -0,8 e -1,7 na qualidade de vida, com valores similares em 24 semanas. Conclusão: os efeitos obtidos neste estudo podem servir de base para cálculos de tamanho amostral e poder estatístico em estudos confirmatórios. Registro Brasileiro de Ensaios Clínicos - RBR 7jd2mm RESUMEN Objetivo: estimar los efectos de intervenciones no farmacológicas para mejoría de la calidad de sueño y de vida de pacientes con insuficiencia cardíaca. Método: estudio piloto de un ensayo controlado aleatorizado con 32 individuos asignados a cuatro grupos. El sueño fue evaluado por el Pittsburgh Sleep Quality Inventory y la calidad de vida relacionada a la salud fue evaluada por el Minnessota Living with Heart Failure Questionnaire, en el inicio y en las semanas 12 y 24 del estudio. Las medias de los resultados por grupo de intervención fueron comparadas con análisis de covariancia y los tamaños de los efectos fueron calculados para cada grupo. Resultados: todos los grupos presentaron mejoría en la calidad de sueño y de vida relacionada a la salud al final del período de intervención (12 semanas) y en el seguimiento de 24 semanas; sin embargo, las diferencias no fueron estadísticamente significativas (p entre 0,22 y 0,40). En 12 semanas, los efectos de las intervenciones variaron entre -2,1 y -3,8 en la calidad de sueño y de -0,8 a -1,7 en la calidad de vida, con valores similares en 24 semanas. Conclusión: los efectos obtenidos en este estudio pueden servir de base para calcular el tamaño de la muestra y del poder estadístico en estudios confirmatorios. Registro Brasileño de Ensayos Clínicos - RBR 7jd2mm.

The study assessed if quadriceps femoris muscle performance of older women can be improved by applying photobiomodulation therapy after a resistance training program. This study is a randomized, controlled trial with concealed allocation, intention-to-treat analysis, and blinded outcome evaluators. Forty-five healthy sedentary older women classified as active or insufficiently active were randomized to groups receiving 8 weeks of quadriceps femoris resistance training plus active group or placebo group, or a control group (no training or photobiomodulation). Surface electromyographic fatigue indexes of vastus medialis, rectus femoris, and vastus lateralis; one-maximum repetition (1-MR); and analysis of inflammatory biomarkers (IL-6, IL-8, and TNF-α cytokines, plus CK and LDH enzymes) were measured at baseline and twice in a 24 h-period after 8 weeks. No differences among the three groups were found in fatigue indexes for all three muscles, although in general, the active group presented improved fatigue indexes from baseline to 8-week outcome, while the other groups did not. Both training groups improved in 1-MR over the 8-week period. Inflammatory biomarkers were not different at long- or short-term among the three groups, except differences in groups for long-term IL-8 changes, differences in time for long-term LDH and short-term TNF-α changes, and interactions of time by group for short-term LDH changes. Quadriceps femoris performance of older women was not improved when photobiomodulation was associated to the proposed quadriceps femoris resistance training, when compared to training without photobiomodulation and a sedentary group.

AIM: The aim of this study was to compare health status, self-efficacy, symptoms of depression and anxiety and post-traumatic stress between two groups of burn victims receiving information on self-care through routine care or an educational programme with telephone reinforcement. BACKGROUND: Self-care post discharge is an important factor on quality of life of burn victims. Reinforcement of self-care programme via telephone follow-up might improve self-efficacy and general health perception in burn victims. DESIGN: Randomized, controlled clinical trial. METHOD: From 2011-2012, we randomized 108 burn victims either to an educational programme on self-care tailored for burn victims according to the cognitive social theory and reinforcement by telephone every 4-6 weeks for 6 months post discharge, or to the routine instructions given at discharge from the hospital. During hospitalization, at discharge, at 6 and 12 months post discharge, we collected data on socio-demographic characteristics, Burns Specific Health Scale Revised (BSHS-R), Perceived Self-Efficacy Scale (PSE), Hospital Anxiety and Depression Scales (HADS) and Impact of the Event Scale (IES). We analysed data using t-test, Chi-square test and linear regression models. RESULTS: Groups were similar regarding clinical and demographic characteristics, except for age. At 6-month follow-up, there were no differences between the groups on BSHS-R, PSE and HADS Depression, while the intervention group showed fewer symptoms of anxiety (HADS Anxiety) and lower IES scores than the control group. CONCLUSION: The educational programme, when compared with usual care, reduced anxiety symptoms and post-traumatic stress. Educational programmes with telephone follow-up might be a viable intervention to improve self-care for burn victims.© 2016 John Wiley & Sons Ltd. Language: en

For people who wear a prosthetic limb, residual-limb fluid volume loss during the day may be problematic and detrimentally affect socket fit. The purpose of this research was to test the capability of a novel liner with adjustable bladders positioned within its wall to mitigate volume loss and facilitate limb fluid volume recovery and retention. Bioimpedance analysis was used to monitor fluid volume changes in the anterior and posterior residual limb of participants with transtibial amputation. Participants underwent six cycles of sitting for 90 s, standing for 90 s, and walking for 5 min with liquid within the bladder-liners. Between the third and fourth cycles, participants sat for 10 min with liquid left within the bladders (Liquid-In) or removed (Liquid-Out). Results showed that participants recovered more fluid volume during the 10 min of sitting with Liquid-Out than Liquid-In (p = 0.09 for anterior and p = 0.04 for posterior). However, those fluid volume recoveries were not well retained in the short term (after the fourth cycle) or the long term (after the sixth cycle). Physiologic differences between sessions, reflected in the rates of fluid volume change at the outset of the session, and excessive stiffness of the bladder-liners may have affected fluid volume retentions.

Design Safety and immunogenicity of a recombinant 14 kDa, fatty acid-binding protein(FABP) from Schistosoma mansoni (rSm14) were evaluated through an open, non-placebo-controlled, dose-standardized trial, performed at a single research site. The vaccine was formulated with glucopyranosyl lipid A (GLA) adjuvant in an oil-in-water emulsion (SE) and investigated in 20 male volunteers from a non-endemic area for schistosomiasis in the state of Rio de Janeiro, Brazil. Fifty microgram rSm14 with 10 μg GLA-SE (rSm14/GLA-SE)/dose were given intramuscularly three times with 30-day intervals. Participants were assessed clinically, biochemically and immunologically for up to 120 days. Methods Participants were screened for inclusion by physical examination, haematology and blood chemistry; then followed to assess adverse events and immunogenicity. Sera were tested for IgG (total and isotypes) and IgE. T cell induction of cytokines IL-2, IL-5, IL-10, IFNγ and TNFα was assessed by Milliplex kit and flow cytometry. Results The investigational product showed high tolerability; some self-limited, mild adverse events were observed during and after vaccine administration. Significant increases in Sm14-specific total IgG, IgG1 and IgG3 were observed 30 days after the first vaccination with specific IgG2 and IgG4 after 60 days. An increase in IgE antibodies was not observed at any time point. The IgG response was augmented after the second dose and 88% of all vaccinated subjects had developed high anti-Sm14 IgG titres 90 days after the first injection. From day 60 and onwards, there was an increase in CD4 + T cells producing single cytokines, particularly TNFα and IL-2, with no significant increase of multi-functional TH1 cells. Conclusion Clinical trial data on tolerability and specific immune responses after vaccination of adult, male volunteers in a non-endemic area for schistosomiasis with rSm14/GLA-SE, support this product as a safe, strongly immunogenic vaccine against schistosomiasis paving the way for follow-up Phase 2 trials. Study registration ID: NCT01154049 at http://www.clinicaltrials.gov .

Testing drugs for anti-aging effects has historically been conducted in mouse life-span studies, but are costly and time consuming, and more importantly, difficult to recapitulate in humans. In addition, life-span studies in mice are not well suited to testing drug combinations that target multiple factors involved in aging. Additional paradigms for testing therapeutics aimed at slowing aging are needed. A new paradigm, designated as the Geropathology Grading Platform (GGP), is based on a standardized set of guidelines developed to detect the presence or absence of low-impact histopathological lesions and to determine the level of severity of high-impact lesions in organs from aged mice. The GGP generates a numerical score for each age-related lesion in an organ, summed for total lesions, and averaged over multiple mice to obtain a composite lesion score (CLS). Preliminary studies show that the platform generates CLSs that increase with the age of mice in an organ-dependent manner. The CLSs are sensitive enough to detect changes elicited by interventions that extend mouse life span, and thus help validate the GGP as a novel tool to measure biological aging. While currently optimized for mice, the GGP could be adapted to any preclinical animal model.

This randomized trial will evaluate the mechanisms of three chronic pain treatments: cognitive therapy (CT), mindfulness meditation (MM), and activation skills (AS). We will determine the extent to which late-treatment improvement in primary outcome (pain interference) is predicted by early-treatment changes in cognitive content, cognitive process, and/or activity level. The shared versus specific role of these mechanisms across the three treatments will be evaluated during treatment (Primary Aim), and immediately post-treatment to examine relapse mechanisms (Secondary Aim). We will enroll 300 individuals with chronic pain (with low back pain as a primary or secondary condition), with 240 projected to complete the study. Participants will be randomly assigned to eight, 1.5 h telehealth group sessions of CT, MM, or AS. Mechanisms and outcomes will be assessed twice daily during 2-week baseline, 4-week treatment period, and 4-week post-treatment epoch via random cue-elicited ecological momentary assessment (EMA); activity level will be monitored during these time epochs via daily monitoring with ActiGraph technology. The primary outcome will be measured by the PROMIS 5-item Pain Interference scale. Structural equation modeling (SEM) will be used to test the primary aims. This study is pre-registered on clinicaltrials.gov (Identifier: NCT03687762). This study will determine the temporal sequence of lagged mediation effects to evaluate rates of change in outcome as a function of change in mediators. The findings will provide an empirical basis for enhancing and streamlining psychosocial chronic pain interventions. Further, results will guide future efforts towards optimizing maintenance of gains to effectively reduce relapse risk.

Objectives To describe the protocol of a randomized controlled trial to evaluate the effectiveness and mechanisms of three behavioral interventions. Methods Participants will include up to 343 Veterans with chronic pain due to a broad range of etiologies, randomly assigned to one of three 8-week manualized in-person group treatments: (1) Hypnosis (HYP), (2) Mindfulness Meditation (MM), or (3) Education Control (EDU). Projected outcomes The primary aim of the study is to compare the effectiveness of HYP and MM to EDU on average pain intensity measured pre- and post-treatment. Additional study aims will explore the effectiveness of HYP and MM compared to EDU on secondary outcomes (i.e., pain interference, sleep, depression, anxiety and PTSD), and the maintenance of effects at 3- and 6-months post-treatment. Participants will have electroencephalogram (EEG) assessments at pre- and post-treatment to determine if the power of specific brain oscillations moderate the effectiveness of HYP and MM (Study Aim 2) and examine brain oscillations as possible mediators of treatment effects (exploratory aim). Additional planned exploratory analyses will be performed to identify possible treatment mediators (i.e., pain acceptance, catastrophizing, mindfulness) and moderators (e.g., hypnotizability, treatment expectations, pain type, cognitive function). Setting The study treatments will be administered at a large Veterans Affairs Medical Center in the northwest United States. The treatments will be integrated within clinical infrastructure and delivered by licensed and credentialed health care professionals.

Background Type 2 Diabetes Mellitus (T2DM) is a chronic disease that is increasing the number of cases worldwide. The treatments currently used have not worked as expected. Alternative and complementary medicines were inserted in health services, especially in primary care, as an attempt to minimize risks and help control diseases such as diabetes. Among the herbal medicines used stands out cinnamon, which can serve as an adjuvant in the control of diabetes. Objective To analyze the effectiveness of 3 grams of cinnamon (Cinnamomum verum) per day for 90 days in reducing glycemic and lipid levels in adults with T2DM compared with placebo METHODS:: A randomized, double-blind, placebo-controlled, phase II trial, which will be conducted at basic health units in the city of Parnaiba, state of Piaui, Brazil. In total, 130 people diagnosed with T2DM, followed at health units, with hemoglobin A1c > 6.5%, and using oral antidiabetic medicines, are expected to participate in the study. The intervention will last for 3 months, and each participant will receive a total of 3 bottles containing 120 capsules in each bottle of cinnamon or placebo. Each person should take 4 capsules daily, for 90 days. The patients will be distributed into the 2 groups by performing block randomization (n = 6) at a ratio of 1:1 according to a code generated by a software. Assessments of socioeconomic, clinical, lifestyle, anthropometric, and laboratory variables will be performed in 2 separate visits. Discussion This study will be the first to investigate cinnamon to reduce glycemic, lipid, and anthropometric levels in Brazil. In case of favorable results, this therapy may be used as an alternative or additional medicine in cases where only oral antidiabetic agents are used and can promote the use of the product to minimize future complications of patients with diabetes and people who do not have the disease. Trial registration RBR-2KKB6D, registered on December 11th, 2018.