Search

Background: The use of digital health applications (German acronym DiGA) for comprehensive patient care is increasing rapidly. Patients with non-organic insomnia can be prescribed an application to manage insomnia. Due to the high prevalence of insomnia in patients with cancer, we were interested in the effect of it and what barriers need to be overcome for its use. The focus of existing studies on acceptance and benefits prompted us to emphasise the analysis of barriers and thus to formulate possible solutions., Methods: To analyse the barriers of use, the study population (patients with self-reported tiredness or sleep disturbance via validated instruments and cancer disease) was divided into 3 groups. In groups 1 (patients who refused to participate in advance) and 2 (patients who refused a prescription), short close-ended questionnaires were used for non-response assessment by treating oncologists. Problem-centred guidelines were used for the telephone interviews with group 3 (patients who did not provide information on DiGA use). Alternatively, group 3 was invited to complete and return the close-ended questionnaire. A quantitative analysis of the non-response reasons was conducted using SPSS in groups 1 and 2, while MAXQDA was used for the qualitative data in group 3., Results: Patients refused to participate at several stages of our study. Quantitative data are available for groups 1 and 2. In the largest group 1, 62% of patients refused to participate due to non-subjective sleep disturbance (177 out of 189 patients) during recruitment by treating oncologists, despite high scores on the screening tool. In the small group 2 (11 out of 15), the most common reasons for withdrawal documented by the oncologists were loss of interest and deteriorating health. The problem-centred qualitative interviews with group 3 (17 patients) revealed that some of them used the prescribed DiGA, despite not being included in the main study and being categorized as lost to follow-up., Conclusion: Analysis of barriers to DiGA use showed that reducing administrative barriers and providing digital and personal support can increase acceptance of the use of DiGAs among cancer patients. Additionally, screening tools can act as a door opener to further communication regarding DiGAs., Trial Registration: German Register of Clinical Trials DRKS00034198, registration date: 7/05/24 (retrospectively registered)., (© 2024. The Author(s).)

Background: Physical activity referral schemes (PARS) are composed of various components, such as a written prescription or a person-centered approach. The role of these components in their effectiveness is yet to be understood. Therefore, we aimed to explore the relationships between PARS components and physical activity, scheme uptake, and adherence rate; and to estimate the effect of PARS., Methods: We searched Scopus, PubMed, Web of Science, CINAHL, ScienceDirect, SpringerLink, HTA, Wiley Online Library, SAGE Journals, Taylor & Francis, Google Scholar, OpenGrey, and CORE. Eligible studies were published between 1990 and November 2023 in English or German, investigated PARS with participants aged ≥ 16 years, and reported physical activity, scheme uptake, or scheme adherence. Separate random-effects meta-analysis by comparison group were conducted for physical activity. Scheme uptake and adherence rates were pooled using proportional meta-analysis. The components were analyzed via univariate meta-regression. We rated the risk of bias using RoB2 and ROBINS-I, and the certainty of evidence using GRADE., Results: Fifty-two studies were included. PARS were more effective in increasing physical activity than usual care (k = 11, n = 5046, Hedges' g = 0.18, 95%CI 0.12 to 0.25; high certainty of evidence). When PARS were compared with physical activity advice or enhanced scheme versions, the pooled Hedges' g values for physical activity were -0.06 (k = 5, n = 1082, 95%CI -0.21 to 0.10; low certainty of evidence), and 0.07 (k = 9, n = 2647, 95%CI -0.03 to 0.18; low certainty of evidence) respectively. Scheme uptake was 87% (95%CI 77% to 94%, k = 14, n = 5000) across experimental studies and 68% (95%CI 51% to 83%, k = 14, n = 25,048) across non-experimental studies. Pooled scheme adherence was 68% (95%CI 55% to 80%, k = 16, n = 3939) and 53% (95%CI 42% to 63%, k = 18, n = 14,605). The meta-regression did not detect any significant relationships between components and physical activity or scheme uptake. A person-centered approach, screening, and brief advice were positively associated with scheme adherence, while physical activity sessions were negatively associated., Conclusion: PARS are more effective in increasing physical activity than usual care only. We did not identify any components as significant predictors of physical activity and scheme uptake. Four components predicted scheme adherence, indicating that the component-effectiveness relationship warrants further research., (© 2024. The Author(s).)

Background: Although the nursing sector gains growing importance in an aging society, students representing the future workforce often show insufficient health. Acknowledging the health-enhancing effects of adequate physical activity, the educational system in Bavaria, Germany, has recently integrated the promotion of physical activity-related health competence (PAHCO) into the nursing curriculum. However, it cannot be assumed that PAHCO has sufficiently permeated the educational practices and routines of the nursing schools. Therefore, the goal of the present study is to examine and compare the effectiveness as well as implementation of different intervention approaches to address PAHCO in the Bavarian nursing school system., Methods: We randomly assign 16 nursing schools (cluster-based) to four study arms (bottom-up, top-down led by teachers, top down led by external physical activity experts, control group). Schools in intervention group 1 (IG-1) develop multicomponent inventions to target PAHCO via cooperative planning (preparation, planning, and implementation phase). Intervention groups 2 and 3 (IG-2, IG-3) receive both an expert-based intervention (developed through intervention mapping) via trained mediators to address PAHCO. External physical activity experts deliver the structured PAHCO intervention in IG-2, while teachers from the nursing schools themselves conduct the PAHCO intervention in IG-3. In line with a hybrid effectiveness implementation trial, we apply questionnaire-based pre-post measurements across all conditions (sample size calculation: n final  = 636) to examine the effectiveness of the intervention approaches and, simultaneously, draw on questionnaires, interview, and protocol data to examine their implementation. We analyze quantitative effectiveness data via linear models (times-group interaction), and implementation data using descriptive distributions and content analyses., Conclusion: The study enables evidence-based decisions about the suitability of three intervention approaches to promote competencies for healthy, physically active lifestyles among nursing students. The findings inform dissemination activities to effectively reach all 185 schools of the Bavarian nursing system., Trial Registration: Clinical trials NCT05817396. Registered on April 18, 2023., (© 2024. The Author(s).)

Background: Physical activity referral schemes (PARS) are complex multicomponent interventions that represent a promising healthcare-based concept for physical activity (PA) promotion. This systematic review and narrative synthesis aimed to identify the constitutive components of PARS and provide an overview of their effectiveness., Methods: Following a published protocol, we conducted a systematic search of PubMed, Scopus, Web of Science, CINAHL, ScienceDirect, SpringerLink, HTA, Wiley Online Library, SAGE Journals, Taylor & Francis, Google Scholar, OpenGrey, and CORE from 1990 to January 2023. We included experimental, quasi-experimental, and observational studies that targeted adults participating in PARS and reported PA outcomes, scheme uptake, or adherence rates. We performed an intervention components analysis using the PARS taxonomy to identify scheme components and extracted data related to uptake, adherence, and PA behavior change. We combined these to provide a narrative summary of PARS effectiveness., Results: We included 57 studies reporting on 36 PARS models from twelve countries. We identified 19 PARS components: a patient-centered approach, individualized content, behavior change theory and techniques, screening, brief advice, written materials, a written prescription, referral, baseline and exit consultation, counselling support session(s), PA sessions, education session(s), action for non-attendance, structured follow-up, a PA network, feedback for the referrer, and exit strategies/routes. The PARS models contained a mean of 7 ± 2.9 components (range = 2-13). Forty-five studies reported PA outcome data, 28 reported uptake, and 34 reported adherence rates. Of these, approximately two-thirds of studies reported a positive effect on participant PA levels, with a wide range of uptake (5.7-100.0%) and adherence rates (8.5-95.0%)., Conclusions: Physical activity referral scheme components are an important source of complexity. Despite the heterogeneous nature of scheme designs, our synthesis was able to identify 19 components. Further research is required to determine the influence of these components on PARS uptake, adherence, and PA behavior change. To facilitate this, researchers and scheme providers must report PARS designs in more detail. Process evaluations are also needed to examine implementation and increase our understanding of what components lead to which outcomes. This will facilitate future comparisons between PARS and enable the development of models to maximize impact., (© 2023. The Author(s).)

Background: The extent to which people are physically active is dependent upon social gradients. Numerous studies have shown that especially people with social disadvantages do not meet the physical activity (PA) recommendations. A promising strategy to alleviate this issue are approaches that promote PA in the general population. In addition, several researchers have raised concerns that population-based health interventions may increase health inequities. The aim of the current review of reviews was therefore to identify successful population-based PA promotion approaches with a particular focus on health equity., Methods: Six electronic databases were examined for systematic reviews on population-based PA promotion for the period 2015 to 2021. A reference list and grey literature search were also conducted. Two independent reviewers used inclusion/exclusion criteria to screen titles and abstracts of the potentially relevant literature and conducted a quality assessment for each identified review. All included reviews of population-based approaches for PA promotion with a focus on disadvantaged populations and/or health equity were narratively summarized., Results: Our search resulted in 4,411 hits. After a systematic review process, six reviews met the inclusion criteria and were included after they were all rated as high quality. We identified that mass-media campaigns, point-of-decision prompts, environmental approaches, policy approaches, and community-based multi-component approaches can promote PA in the general population. Across populations with social disadvantages mass-media campaigns, point-of-decision prompts and policy approaches are likely to be effective as long as they are tailored. Regarding environmental approaches, the results are inconsistent. None of the reviews on community-based multi-component approaches provided evidence on health equity., Conclusion: There are several effective approaches to promote PA in the general population but evidence regarding health equity is still sparse. Future studies should therefore pay more attention to this missing focus. Furthermore, there is a lack of evidence regarding the type of tailoring and the long-term impact of population-based approaches to PA promotion. However, this requires appropriate funding programmes, complex study designs and evaluation methods., (© 2023. The Author(s).)

Background: While effective physical activity referral schemes (PARSs) and related structures for promoting physical activity (PA) already exist in several countries, in Germany, PARSs have not yet been implemented systematically and nationwide. Through a co-production approach with relevant actors in the German healthcare system, a PARS was developed, and an implementation plan was created (e.g. financing). This study protocol aims to evaluate the developed PARS for people with non-communicable diseases (NCDs) in Germany regarding its potential effectiveness and implementation success., Methods: To evaluate the effectiveness and implementation success of the PARS, we will apply a pragmatic cluster-randomised controlled trial (cRCT) in Hybrid II design by comparing two intervention groups (PARS vs PA advice [PAA]). The trial will take place in the Nürnberg metropolitan region, with 24 physician practices recruiting 567 people with NCDs. Both groups will receive brief PA advice from a physician to initially increase the participants' motivation to change their activity level. Subsequently, the PARS group will be given individualised support from an exercise professional to increase their PA levels and be transferred to local exercise opportunities. In contrast, participants in the PAA group will receive only the brief PA advice as well as information and an overview of regional PA offerings to become more active at their own initiative. After 12 and 24 weeks, changes in moderate to vigorous PA and in physical activity-related health competence (movement competence, control competence, self-regulation competence) will be measured as primary outcomes. Secondary outcomes will include changes in quality of life. To measure implementation success, we refer to the RE-AIM framework and draw on patient documentation, interviews, focus groups and surveys of the participating actors (physicians, exercise professionals)., Discussion: Through a between-group comparison, we will investigate whether additional individual support by an exercise professional compared to brief PA advice alone leads to higher PA levels in people with NCDs. The acceptance and feasibility of both interventions in routine care in the German healthcare system will also be evaluated., Trial Registration: ClinicalTrials.gov, NCT04947787 . Registered 01 June 2021., (© 2022. The Author(s).)

Background: Co-creation approaches are increasingly used in physical activity promotion to develop interventions tailored to the target group and setting. The resulting complexity of such interventions raises challenges in evaluation. Accordingly, little is known about the effectiveness of co-created interventions and the underlying processes that impact their sustainable implementation. In this study, we attempt to fill this gap by evaluating co-created multi-component physical activity interventions in vocational education and training in nursing care and automotive mechatronics regarding (1) their sustainable implementation at the institutional level and (2) the effectiveness of single intervention components at the individual level., Methods: Following a multimethod design, we conducted a questionnaire survey (n = 7) and semi-structured interviews (n = 4) to evaluate the sustainability of the interventions. Quantitative data were analyzed descriptively, and qualitative data were analyzed using qualitative content analysis. To examine the interventions' effectiveness, we conducted two non-randomized controlled trials (n = 111). Analysis of variance was used to examine differences between groups., Results: At the institutional level, long-term implementation of single intervention components in nursing care was observed; in contrast, long-term implementation in automotive mechatronics was not observed. In this context, various factors at the outer contextual (e.g., COVID-19 pandemic), inner contextual (e.g., health-promoting leadership), intervention (e.g., acceptance), and personal levels (e.g., champion) influenced sustainability. At the individual level, no significant intervention effects were found for changes in physical activity behavior and physical activity-related health competence., Conclusion: The role of co-creation on the effectiveness and sustainability of physical activity promotion in vocational education and training cannot be answered conclusively. Only in the nursing care sector, a co-creation approach appeared promising for long-term intervention implementation. Sustainable implementation depends on various influencing factors that should be considered from the outset. Demonstrating effectiveness at the individual level was challenging. To conclusively clarify both the role and impact of co-creation, methodologically complex and elaborate evaluation designs will be required in future research projects., Trial Registration: This study was retrospectively registered at clinicaltrials.gov on 24/08/2021 ( NCT05018559 )., (© 2022. The Author(s).)

Background: The long-term effects of behavioural medical rehabilitation (BMR), as a type of multidisciplinary rehabilitation, in the treatment of chronic non-specific low back pain (CLBP) have been shown. However, the specific effects of behavioural exercise therapy (BET) compared to standard exercise therapy (SET) within BMR are not well understood. The aim of the study was to assess the effectiveness of BMR + BET compared to BMR + SET in individuals with CLBP in a two-armed, pre-registered, multicentre, parallel, randomised controlled trial (RCT)., Methods: A total of 351 adults with CLBP in two rehabilitation centres were online randomised based on an 'urn randomisation' algorithm to either BMR + SET (n = 175) or BMR + BET (n = 176). Participants in both study groups were non-blinded and received BMR, consisting of an multidisciplinary admission, a psychosocial assessment, multidisciplinary case management, psychological treatment, health education and social counselling. The intervention group (BMR + BET) received a manualised, biopsychosocial BET within BMR. The aim of BET was to develop self-management strategies in coping with CLBP. The control group (BMR + SET) received biomedical SET within BMR with the aim to improve mainly physical fitness. Therapists in both study groups were not blinded. The BMR lasted on average 27 days, and both exercise programmes had a mean duration of 26 h. The primary outcome was functional ability at 12 months. Secondary outcomes were e.g. pain, avoidance-endurance, pain management and physical activity. The analysis was by intention-to-treat, blinded to the study group, and used a linear mixed model., Results: There were no between-group differences observed in function at the end of the BMR (mean difference, 0.08; 95% CI - 2.82 to 2.99; p = 0.955), at 6 months (mean difference, - 1.80; 95% CI; - 5.57 to 1.97; p = 0.349) and at 12 months (mean difference, - 1.33; 95% CI - 5.57 to 2.92; p = 0.540). Both study groups improved in the primary outcome and most secondary outcomes at 12 months with small to medium effect sizes., Conclusion: BMR + BET was not more effective in improving function and other secondary outcomes in individuals with CLBP compared to BMR + SET., Trial Registration: Current controlled trials NCT01666639 , 16/08/2012.

Background: Co-creation strategies, such as cooperative planning, are promising as a means to ensure that physical activity interventions address real-world problems and are tailored to the target group. This has already been validated in diverse settings. However, questions targeting the transferability of cooperative planning to new settings and the key factors influencing its success or failure remain unclear. At the same time, co-creation processes are complex, and evaluation can be challenging. Following calls for detailed reporting, this paper describes the programme activities, the underlying logic, and methodological design of a study that aims to evaluate the transfer of cooperative planning to new settings and to explore the associated key determinants., Methods: Cooperative planning was utilized as a strategy to target physical activity promotion in three real-world German settings in the nursing care and automotive mechatronics sectors. This involved researchers working alongside stakeholders from practice and policy to conjointly develop new interventions to promote physical activity in physically demanding jobs. A pragmatic approach is used to evaluate both the transferability and key determinants of this strategy. We developed a logic model for this co-creation process that describes the underlying assumptions and guides the evaluation. The evaluation outcomes of this study include planning meetings, newly developed interventions, and the determinants that are likely to affect cooperative planning. Quantitative and qualitative data will be collected using questionnaires, documents, and interviews. The quantitative data will be analysed descriptively, while the qualitative data will mainly be analysed using qualitative content analysis, split by settings. Subsequently, data triangulation will be used to integrate the quantitative and qualitative findings, which will then be compared across all three settings., Discussion: The study findings will contribute to a better understanding of co-creation strategies, their transferability, and key determinants. The practical implications can include a checklist for assessing key determinants and a guideline for transferring cooperative planning into new settings to benefit more people. Ultimately, this study will help to advance co-creation strategies and may be relevant for researchers, practitioners, and policy-makers targeting physical activity promotion in various contexts., Trial Registration: Open Science Framework: https://osf.io/r6xnt/ (retrospectively registered).

Background: This study aims to investigate the relationship between post-diagnosis physical activity and mortality in patients with selected noncommunicable diseases, including breast cancer, lung cancer, type 2 diabetes, ischemic heart disease, stroke, chronic obstructive pulmonary disease (COPD), osteoarthritis, low back pain and major depressive disorder., Methods: A systematic search was conducted of PubMed, Scopus and the Web of Science from their inception to August 2018. Additionally, the search was updated in August 2019. Eligibility criteria included prospective observational studies examining the relationship between at least three physical activity categories (e.g. low, moderate, high) and all-cause mortality as the primary outcome., Results: In total, 28 studies were included in the meta-analysis: 12 for breast cancer, 6 for type 2 diabetes, 8 for ischemic heart disease and 2 for COPD. The linear meta-analysis revealed that each 10 metabolic equivalent task hours increase of physical activity per week was associated with a 22% lower mortality rate in breast cancer patients (Summary Hazard Ratio [HR], 0.78; 95% CI: 0.71, 0.86; I 2 : 90.1%), 12% in ischemic heart disease patients (HR, 0.88; 95% CI: 0.83, 0.93; I 2 : 86.5%), 30% in COPD patients (HR, 0.70; 95% CI: 0.45, 1.09; I 2 : 94%) and 4% in type 2 diabetes patients (HR, 0.96; 95% CI: 0.93, 0.99; I 2 : 71.8%). There was indication of a non-linear association with mortality risk reductions even for low levels of activity, as well as a flattening of the curve at higher levels of activity. The certainty of evidence was low for breast cancer, type 2 diabetes and ischemic heart disease but only very low for COPD., Conclusion: Higher levels of post-diagnosis physical activity are associated with lower mortality rates in breast cancer, type 2 diabetes, ischemic heart disease and COPD patients, with indication of a no-threshold and non-linear dose-response pattern.

Background: Although the health benefits of physical activity (PA) are well known, young people's level of PA is often insufficient and tends to decline in adolescence. Numerous studies have investigated the effectiveness of PA-promoting interventions among young people, but none have reviewed the effectiveness of PA interventions in the vocational education and training (VET) setting. This systematic review aims to (1) synthesize and review the available literature on PA-promoting interventions in VET and (2) examine the effects of these interventions on PA-related outcomes such as PA level, physical fitness, physiological parameters, or psychological factors., Methods: Five electronic databases were searched for studies involving adolescents aged 15 to 20 years that took place in VET settings and evaluated the effects of interventions with a PA component on PA-related outcomes such as PA level, physical fitness, physiological parameters, or psychological factors. The screening process and the quality assessment were conducted by two independent reviewers; data extraction was conducted by one reviewer and verified by another., Results: The literature search identified 18,959 articles and 11,282 unique records. After the screening process, nine studies, all coming from European or Asian countries, met the pre-defined eligibility criteria and were included in qualitative analyses. All but two studies reported significant improvements for at least one PA-related outcome. The interventions substantially differed in their development approaches (top-down vs. bottom-up approaches), complexity (multi- vs. single-component), and addressed behavior (multi-behavioral vs. single-behavioral). The most conspicuous finding was that bottom-up approaches tend to improve outcomes at the psychological level and top-down approaches at the physical level. Regarding the interventions' complexity and addressed behavior, we did not reveal any conclusive results., Conclusion: This systematic review highlights the varying effects of PA-promoting interventions in VET. Nevertheless, heterogeneous effects, overall weak study quality and availability of studies only from two continents limited our ability to draw clear conclusions about the potentially most effective intervention strategies. Therefore, future research should focus on high-quality studies with long-term follow-ups to make recommendations for practical use., Trial Registration: PROSPERO CRD42018109845.

Background: Existing physical activity guidelines predominantly focus on healthy age-stratified target groups. The objective of this study was to develop evidence-based recommendations for physical activity (PA) and PA promotion for German adults (18-65 years) with noncommunicable diseases (NCDs)., Methods: The PA recommendations were developed based on existing PA recommendations. In phase 1, systematic literature searches were conducted for current PA recommendations for seven chronic conditions (osteoarthrosis of the hip and knee, chronic obstructive pulmonary disease, stable ischemic heart disease, stroke, clinical depression, and chronic non-specific back pain). In phase 2, the PA recommendations were evaluated on the basis of 28 quality criteria, and high-quality recommendations were analysed. In phase 3, PA recommendations for seven chronic conditions were deducted and then synthesised to generate generic German PA recommendations for adults with NCDs. In relation to the recommendations for PA promotion, a systematic literature review was conducted on papers that reviewed the efficacy/effectiveness of interventions for PA promotion in adults with NCDs., Results: The German recommendations for physical activity state that adults with NCDs should, over the course of a week, do at least 150 min of moderate-intensity aerobic PA, or 75 min of vigorous-intensity aerobic PA, or a combination of both. Furthermore, muscle-strengthening activities should be performed at least twice a week. The promotion of PA among adults with NCDs should be theory-based, specifically target PA behaviour, and be tailored to the respective target group. In this context, and as an intervention method, exercise referral schemes are one of the more promising methods of promoting PA in adults with NCDs., Conclusion: The development of evidence-based recommendations for PA and PA promotion is an important step in terms of the initiation and implementation of actions for PA-related health promotion in Germany. The German recommendations for PA and PA promotion inform adults affected by NCDs and health professionals on how much PA would be optimal for adults with NCDs. Additionally, the recommendations provide professionals entrusted in PA promotion the best strategies and interventions to raise low PA levels in adults with NCDs. The formulation of specific PA recommendations for adults with NCDs and their combination with recommendations on PA promotion is a unique characteristic of the German recommendations.

Background: This study aims to explore exercise therapists' perspectives on the topic of physical activity promotion (PAP) with a focus on identifying (i) the intervention content and methodological approaches used for promoting physical activity (PA) in daily practice and (ii) the barriers and facilitators that affect PAP., Methods: This qualitative study comprised the heads of exercise therapy departments ( n  = 58; 41% women; mean age = 45 years) from different rehabilitation clinics in Germany. Each participant took part in a semi-structured focus-group discussion on PAP in exercise therapy. The findings of the focus groups were processed and interpreted using a conventional qualitative content analysis., Results: The exercise therapists demonstrated detailed didactic-methodological strategies and action orientations for PAP. The identified core topics of the content and methods of PAP were (1) conceptualization, (2) exercise and PA for enjoyment and pleasure, (3) education with practice-theory combinations, (4) media and materials for self-directed training, and (5) strategies to enhance personal responsibility and independence. The core topics for the associated barriers and facilitators were (1) structural conditions, (2) the role of exercise therapists, (3) the interdisciplinary rehabilitation team, (4) rehabilitant experiences and expectations, and (5) aftercare services., Conclusion: The topic of PAP is addressed with a high level of variability; exercise therapists involved in this study identify various methods and content for the promotion of PA within their individual practices. However, they display a limited awareness of existing evidence- and theory-based concepts for the promotion of PA as well as underlying theories of behavioural change. This variability may be due to the lack of a defined common framework for promoting PA, insufficient emphasis being placed on PA promotion in the current curricula and training, or extensive conceptual differences within German exercise therapy departments (e.g. different weighting of PAP)., Competing Interests: Competing interestsThe authors declare that they have no competing interests., (© The Author(s). 2019.)

Background: Women with pathogenic BRCA germline mutations have an increased risk for breast and ovarian cancer that seems to be modified by life-style factors. Though, randomized trials investigating the impact of lifestyle interventions on cancer prevention and prognosis in BRCA carriers are still missing., Methods: We implemented a multicenter, prospective randomized controlled trial in BRCA1/2 patients, comparing a lifestyle intervention group (IG) with a control group (CG) with the primary aim to prove feasibility. Intervention comprised a structured, individualized endurance training alongside nutrition education based on the Mediterranean diet (MD) for 3 months, plus monthly group training and regular telephone contact during the subsequent 9 months. The CG attended one session on healthy nutrition and the benefits of physical activity. Primary endpoints were feasibility, acceptance and satisfaction over 12 months. Furthermore, effects on physical fitness, diet profile, body mass index (BMI), quality of life and perceived stress were investigated., Results: Sixty-eight participants (mean age 41, mean BMI 23.2 kg/m 2 ) were enrolled, of whom 55 (81%, 26 IG, 29 CG) completed 12 months. 73% (n = 26) participated in at least 70% of all intervention sessions. Predictors for drop-outs (19%; n = 13) or non-adherence (27%; n = 7) were not found. 73% rated the program highly and 80% would participate again. Severe adverse events did not occur. Positive effects in the IG compared to the CG were observed for secondary endpoints: BMI, MD eating pattern and stress levels., Conclusions: This lifestyle intervention was feasible, safe and well accepted. Positive results on eating habits, physical fitness and stress levels warrant a larger randomized trial., Trial Registration: The study has been retrospectively registered at ClinicalTrials.gov (reference: NCT02087592 ) on March 12, 2014. The first patient was included on February 24, 2014.

Background: Pulmonary rehabilitation programs often fail to substantially enhance long-term physical activity in patients with chronic obstructive pulmonary disease (COPD). The reasons for successful physical activity changes in patients with COPD are not well understood. The need to better understand the determinants of physical activity in patients with COPD and effective rehabilitation strategies to improve physical activity is evident., Methods/design: The STAR study (Stay Active after Rehabilitation) investigates, in a randomized controlled trial, the additional effect of a pedometer-based behavior-change intervention during inpatient pulmonary rehabilitation on objectively measured physical activity 6 weeks and 6 months post rehabilitation. The intervention uses the behavior-change techniques (1) instruction on how, where and when to perform the behavior, (2) prompt goal setting for physical activity, (3) prompt self-monitoring of behavior, and (4) feedback on behavior. The primary outcome of physical activity will be measured using a physical activity monitor (Actigraph wGT3X-BT) for a period of 7 days, firstly 2 weeks before rehabilitation begins (t0) as well as 6 weeks and 6 months after rehabilitation (t3, t4). Additionally, to predict physical activity progression after rehabilitation, a complex personal diagnostics battery, including questionnaires as well as functional assessments, is to be carried out at the start and end of rehabilitation (t1, t2). This battery is based on the foundational ideas of the Physical Activity-Related health Competence model. Five hundred and two patients with COPD, aged 18 years or older and admitted for an approved pulmonary rehabilitation, will be enrolled in the STAR study., Discussion: The STAR study is designed as a randomized controlled trial to gain a better understanding of the personal determinants of physical activity in patients with COPD and to evaluate a pedometer-based physical activity-change intervention in the context of inpatient pulmonary rehabilitation. The results enable the future identification of patients with COPD who will find it difficult to engage in long-term physical activity after rehabilitation. Based on this, intervention strategies to promote physical activity in the content of pulmonary rehabilitation can be optimized., Trial Registration: Clinicaltrials.gov, ID: NCT02966561 . Registered retrospectively after the start of the recruitment in June 2016 on 22 November 2016. All protocol modifications will be registered in the trial registry.

Background: Women with highly penetrant BRCA mutations have a 55-60% lifetime risk for breast cancer and a 16-59% lifetime risk for ovarian cancer. However, penetrance differs interindividually, indicating that environmental and behavioral factors may modify this risk. These include lifestyle factors such as physical activity status, dietary habits, and body weight. The modification of penetrance by changing lifestyle factors has not thus far been investigated in a randomized trial in BRCA mutation carriers., Methods: Therefore, we intend to enroll 60 BRCA1/2 mutation carriers in a pilot feasibility study (Lifestyle Intervention Study in Women with Hereditary Breast and Ovarian Cancer (LIBRE) pilot). This multi-center, prospective, controlled trial aims to randomize (1:1) participants into a (1) multi-factorial lifestyle intervention group (IG) versus (2) the control group with usual care (CG). The primary endpoint is feasibility and acceptance of a structured interdisciplinary lifestyle intervention program over 12 months (at least 70% of the patients to complete the 1-year intervention). Furthermore, the effects on physical fitness, BMI, quality of life, and stress coping capacity will be investigated. During the first 3 months, women in the IG will receive structured, individualized and mainly supervised endurance training of ≥18 MET*h/week (MET = metabolic equivalent task) and personal nutritional counseling based on the Mediterranean diet. During the subsequent 9 months, the IG will receive monthly group training sessions and regular telephone contacts for motivation, whereas the CG will only receive usual care (one general counseling on healthy nutrition and benefits of regular physical activity on health status). At randomization and subsequent time points (3, 6, 12 months), cardiopulmonary fitness will be assessed by spiroergometry and nutritional and psychological status by validated questionnaires., Discussion: This pilot study will investigate the optimal strategy to improve physical fitness, nutritional habits, and psychological factors in women at high risk for developing breast or ovarian cancer. The results of this pilot feasibility study will be the basis for a larger prospective randomized trial including clinical events (LIBRE)., Trial Registration: ClinicalTrials.gov, NCT02087592.

Background: Female handball athletes are at a particular risk of sustaining lower extremity injuries. The study examines time-dependent adaptations of static and dynamic balance as potential injury risk factors to a specific warm-up program focusing on neuromuscular control., Methods: Fourty one (24.0 ± 5.9 years) female handball athletes were randomized to an intervention or control group. The intervention group implemented a 15-min specific neuromuscular warm-up program, three times per week for eleven weeks, whereas the control group continued with their regular warm-up. Balance was assessed at five time points. Measures included the star excursion balance test (SEBT), and center of pressure (COP) sway velocity during single-leg standing., Results: No baseline differences existed between groups in demographic data. Adherence to neuromuscular warm-up was 88.7 %. Mean COP sway velocity decreased significantly over time in the intervention group (-14.4 %; p  < .001), but not in the control group (-6.2 %; p  = 0.056). However, these effects did not differ significantly between groups ( p  = .098). Mean changes over time in the SEBT score were significantly greater ( p  = .014) in the intervention group (+5.48) compared to the control group (+3.45). Paired t-tests revealed that the first significant balance improvements were observed after 6 weeks of training., Conclusions: A neuromuscular warm-up positively influences balance variables associated with an increased risk of lower extremity injuries in female handball athletes. The course of adaptations suggests that a training volume of 15 min, three times weekly over at least six weeks produces measurable changes., Trial Registration: Retrospectively registered on 4th October 2016. Registry: clinicaltrials.gov. Trial number: NCT02925377.

Background: Women with highly penetrant BRCA mutations have a 55-60 % lifetime risk for breast cancer and a 16-59 % lifetime risk of developing ovarian cancer. However, penetrance differs interindividually, indicating that environmental and behavioral factors may modify this risk. It is well documented that the risk for sporadic breast cancer disease can be modified by changing lifestyle factors that primarily include physical activity, dietary habits, and body weight. It can thus be hypothesized that the modification of these lifestyle factors may also influence the incidence and progression of cancer in BRCA mutation carriers., Methods/design: This multicenter, interdisciplinary, prospective, two-armed, randomized (1:1) controlled trial aims to enroll a minimum of 600 BRCA1 and BRCA2 mutation carriers to partake in either a lifestyle intervention or usual care. The study primarily aims to demonstrate an improvement of nutritional behavior (adherence to the Mediterranean diet), body mass index, and physical fitness. Furthermore, the effects on quality of life, stress coping capacity, breast cancer incidence, and mortality will be investigated. The intervention group (IG) will receive a structured lifestyle intervention over 12 months, whereas the control group (CG) will only receive information regarding a healthy lifestyle. During the first 3 months, women in the IG will receive structured, individualized, and mainly supervised endurance training with a minimum of 18 MET-h physical activity per week and nutrition education based on the Mediterranean diet. Over the following 9 months, IG monthly group training sessions and regular telephone contacts will motivate study participants. The CG will receive one general training session about healthy nutrition in accordance with the recommendations of the German Society of Nutrition (standard of care in Germany) and the benefits of regular physical activity on health status. At randomization and subsequent time points (3 and 12 months), cardiopulmonary fitness will be assessed by spiroergometry, and nutritional and psychological status will be assessed by validated questionnaires, interviews, and clinical examinations., Discussion: As data on the role of lifestyle intervention in women with a hereditary risk for breast and ovarian cancer are currently lacking, this study will be of major importance from a scientific, as well as a practical advice viewpoint. It will investigate the optimal strategy to improve physical fitness, nutritional status, and psychological factors such as quality of life, perceived stress, optimism, as well as incidence and outcome of cancer in this selected group of women at high risk. If the study indicates a positive long-term outcome, a structured lifestyle intervention program could be added to health care prevention strategies for BRCA1 and BRCA2 mutation carriers., Trial Registration: ClinicalTrials.gov: NCT02516540 . Registered on 22 July 2015.

Background: The use of RNAseq to resolve the transcriptional organization of an organism was established in recent years and also showed the complexity and dynamics of bacterial transcriptomes. The aim of this study was to comprehensively investigate the transcriptome of the industrially relevant amino acid producer and model organism Corynebacterium glutamicum by RNAseq in order to improve its genome annotation and to describe important features for transcription and translation., Results: RNAseq data sets were obtained by two methods, one that focuses on 5'-ends of primary transcripts and another that provides the overall transcriptome with an improved resolution of 3'-ends of transcripts. Subsequent data analysis led to the identification of more than 2,000 transcription start sites (TSSs), the definition of 5'-UTRs (untranslated regions) for annotated protein-coding genes, operon structures and many novel transcripts located between or in antisense orientation to protein-coding regions. Interestingly, a high number of mRNAs (33%) is transcribed as leaderless transcripts. From the data, consensus promoter and ribosome binding site (RBS) motifs were identified and it was shown that the majority of genes in C. glutamicum are transcribed monocistronically, but operons containing up to 16 genes are also present., Conclusions: The comprehensive transcriptome map of C. glutamicum established in this study represents a major step forward towards a complete definition of genetic elements (e.g. promoter regions, gene starts and stops, 5'-UTRs, RBSs, transcript starts and ends) and provides the ideal basis for further analyses on transcriptional regulatory networks in this organism. The methods developed are easily applicable for other bacteria and have the potential to be used also for quantification of transcriptomes, replacing microarrays in the near future.

Background: Recent discoveries on bacterial transcriptomes gave evidence that small RNAs (sRNAs) have important regulatory roles in prokaryotic cells. Modern high-throughput sequencing approaches (RNA-Seq) enable the most detailed view on transcriptomes offering an unmatched comprehensiveness and single-base resolution. Whole transcriptome data obtained by RNA-Seq can be used to detect and characterize all transcript species, including small RNAs. Here, we describe an RNA-Seq approach for comprehensive detection and characterization of small RNAs from Corynebacterium glutamicum, an actinobacterium of high industrial relevance and model organism for medically important Corynebacterianeae, such as C. diphtheriae and Mycobacterium tuberculosis., Results: In our RNA-Seq approach, total RNA from C. glutamicum ATCC 13032 was prepared from cultures grown in minimal medium at exponential growth or challenged by physical (heat shock, cold shock) or by chemical stresses (diamide, H2O2, NaCl) at this time point. Total RNA samples were pooled and sequencing libraries were prepared from the isolated small RNA fraction. High throughput short read sequencing and mapping yielded over 800 sRNA genes. By determining their 5'- and 3'-ends and inspection of their locations, these potential sRNA genes were classified into UTRs of mRNAs (316), cis-antisense sRNAs (543), and trans-encoded sRNAs (262). For 77 of trans-encoded sRNAs significant sequence and secondary structure conservation was found by a computational approach using a whole genome alignment with the closely related species C. efficiens YS-314 and C. diphtheriae NCTC 13129. Three selected trans-encoded sRNAs were characterized by Northern blot analysis and stress-specific transcript patterns were found., Conclusions: The study showed comparable numbers of sRNAs known from genome-wide surveys in other bacteria. In detail, our results give deep insight into the comprehensive equipment of sRNAs in C. glutamicum and provide a sound basis for further studies concerning the functions of these sRNAs.

Background: In Germany, a multidisciplinary rehabilitation named "behavioural medical rehabilitation" (BMR) is available for treatment of chronic low back pain (clbp). A central component of BMR is standard exercise therapy (SET), which is directed mainly to improve physical fitness. There is a need to address psychosocial factors within SET and therefore to improve behavior change with a focus on the development of self-management skills in dealing with clbp. Furthermore, short-term effectiveness of BMR with a SET has been proven, but the impact of a behavioural exercise therapy (BET) for improvement of the long-term effectiveness of BMR is unclear., Methods/design: To compare the effectiveness of two exercise programs with different approaches within BMR on the effects of BMR a prospective randomized controlled trial (RCT) in two rehabilitation centres will be performed. 214 patients aged 18-65 with clbp will be, based on an "urn randomisation"-algorithm, randomly assigned to a BMR with SET (function-oriented, n=107) and BMR with BET (behaviour-oriented, n=107). Both exercise programs have a mean duration of 26 hours in three weeks and are delivered by a limited number of not-blinded study therapists in closed groups with six to twelve patients who will be masked regarding study group. The main differences of BET lie in its detailed manualised program with a theory-based, goal-orientated combination of exercise, education and behavioural elements, active participation of patients and consideration of their individual preferences and previous experiences with exercise. The primary outcome is functional ability assessed with the Hannover Functional Ability Questionnaire directly before and after the rehabilitation program, as well as a six and twelve-month follow-up., Discussion: This RCT is designed to explore the effects of BET on the effectiveness of a BMR compared to a BMR with SET in the management of patients with clbp. Methodological challenges arise from conducting a RCT within routine health care as well as from ensuring high treatment integrity. Findings of this study might contribute to a better understanding of the mechanism of action of BMR and the special effects of BET and may be used to improve the quality of these interventions in routine care, therefore reducing the burden to patients with disabling clbp., Trial Registration: Current controlled trials NCT01666639.

Background: Although resistance exercise interventions have been shown to be beneficial in prefrail or frail older adults it remains unclear whether there are residual effects when the training is followed by a period of detraining. The aim of this study was to establish the sustainability of a muscle power or muscle strength training effect in prefrail older adults following training and detraining., Methods: 69 prefrail community-dwelling older adults, aged 65-94 years were randomly assigned into three groups: muscle strength training (ST), muscle power training (PT) or controls. The exercise interventions were performed for 60 minutes, twice a week over 12 weeks. Physical function (Short Physical Performance Battery=SPPB), muscle power (sit-to-stand transfer=STS), self-reported function (SF-LLFDI) and appendicular lean mass (aLM) were measured at baseline and at 12, 24 and 36 weeks after the start of the intervention., Results: For the SPPB, significant intervention effects were found at 12 weeks in both exercise groups (ST: p = 0.0047; PT: p = 0.0043). There were no statistically significant effects at 24 and 36 weeks. In the ST group, the SPPB declined continuously after stop of exercising whereas the PT group and controls remained unchanged. No effects were found for muscle power, SF-LLFDI and aLM., Conclusions: The results showed that both intervention types are equally effective at 12 weeks but did not result in statistically significant residual effects when the training is followed by a period of detraining. The unchanged SPPB score at 24 and 36 weeks in the PT group indicates that muscle power training might be more beneficial than muscle strength training. However, more research is needed on the residual effects of both interventions. Taken the drop-out rates (PT: 33%, ST: 21%) into account, muscle power training should also be used more carefully in prefrail older adults., Trial Registration: This trial has been registered with clinicaltrials.gov (NCT00783159)

Background: Health information technology can enhance self-management and quality of life for patients with chronic disease and overcome healthcare barriers for patients with limited English proficiency. After a randomized controlled trial of a multilingual automated telephone self-management support program (ATSM) improved patient-centered dimensions of diabetes care in safety net clinics, we collaborated with a nonprofit Medicaid managed care plan to translate research into practice, offering ATSM as a covered benefit and augmenting ATSM to promote medication activation. This paper describes the protocol of the Self-Management Automated and Real-Time Telephonic Support Project (SMARTSteps)., Methods/design: This controlled quasi-experimental trial used a wait-list variant of a stepped wedge design to enroll 362 adult health plan members with diabetes who speak English, Cantonese, or Spanish and receive care at 4 publicly-funded clinics. Through language-stratified randomization, participants were assigned to four intervention statuses: SMARTSteps-ONLY, SMARTSteps-PLUS, or wait-list for either intervention. In addition to usual primary care, intervention participants received 27 weekly calls in their preferred language with rotating queries and response-triggered education about self-care, medication adherence, safety concerns, psychological issues, and preventive services. Health coaches from the health plan called patients with out-of-range responses for collaborative goal setting and action planning. SMARTSteps-PLUS also included health coach calls to promote medication activation, adherence and intensification, if triggered by ATSM-reported non-adherence, refill non-adherence from pharmacy claims, or suboptimal cardiometabolic indicators. Wait-list patients crossed-over to SMARTSteps-ONLY or -PLUS at 6 months. For participants who agreed to structured telephone interviews at baseline and 6 months (n = 252), primary outcomes will be changes in quality of life and functional status with secondary outcomes of 6-month changes in self-management behaviors/efficacy and patient-centered processes of care. We will also evaluate 6-month changes in cardiometabolic (HbA1c, blood pressure, and LDL) and utilization indicators for all participants., Discussion: Outcomes will provide evidence regarding real-world implementation of ATSM within a Medicaid managed care plan serving safety net settings. The evaluation trial will provide insight into translating and scaling up health information technology interventions for linguistically and culturally diverse vulnerable populations with chronic disease., Trial Registration: ClinicalTrials.gov: NCT00683020.

Background: Prevention of falls in the elderly is a public health target in many countries around the world. While a large number of trials have investigated the effectiveness of fall prevention programs, few focussed on interventions embedded in the general practice setting and its related network. In the Prevent Falls (PreFalls) trial we aim to investigate the effectiveness of a pre-tested multi-modal intervention compared to usual care in this setting., Methods/design: PreFalls is a controlled multicenter prospective study with cluster-randomized allocation of about 40 general practices to an experimental or a control group. We aim to include 382 community dwelling persons aged 65 and older with an increased risk of falling. All participating general practitioners are trained to systematically assess the risk of falls using a set of validated tests. Patients from intervention practices are invited to participate in a 16-weeks exercise program with focus on fall prevention delivered by specifically trained local physiotherapists. Patients from practices allocated to the control group receive usual care. Main outcome measure is the number of falls per individual in the first 12 months (analysis by negative binomial regression). Secondary outcomes include falls in the second year, the proportion of participants falling in the first and the second year, falls associated with injury, risk of falls, fear of falling, physical activity and quality of life., Discussion: Reducing falls in the elderly remains a major challenge. We believe that with its strong focus on a both systematic and realistic fall prevention strategy adapted to primary care setting PreFalls will be a valuable addition to the scientific literature in the field., Trial Registration: NCT01032252.

Background: There is strong, internationally confirmed evidence for the short-term effectiveness of multimodal interdisciplinary specific treatment programs for chronic back pain. However, the verification of long-term sustainability of achieved effects is missing so far. For long-term improvement of pain and functional ability high intervention intensity or high volume seems to be necessary (> 100 therapy hours). Especially in chronic back pain rehabilitation, purposefully refined aftercare treatments offer the possibility to intensify positive effects or to increase their sustainability. However, quality assured goal-conscious specific aftercare programs for the rehabilitation of chronic back pain are absent., Methods/design: This study aims to examine the efficacy of a specially developed bio-psycho-social chronic back pain specific aftercare intervention (RÜCKGEWINN) in comparison to the current usual aftercare (IRENA) and a control group that is given an educational booklet addressing pain-conditioned functional ability and back pain episodes. Overall rehabilitation effects as well as predictors for compliance to the aftercare programs are analysed. Therefore, a multicenter prospective 3-armed randomised controlled trial is conducted. 456 participants will be consecutively enrolled in inpatient and outpatient rehabilitation and assigned to either one of the three study arms. Outcomes are measured before and after rehabilitation. Aftercare programs are assessed at ten month follow up after dismissal form rehabilitation., Discussion: Special methodological and logistic challenges are to be mastered in this trial, which accrue from the interconnection of aftercare interventions to their residential district and the fact that the proportion of patients who take part in aftercare programs is low. The usability of the aftercare program is based on the transference into the routine care and is also reinforced by developed manuals with structured contents, media and material for organisation assistance as well as training manuals for therapists in the aftercare.

Background: Although most patients with low back pain (LBP) recover within a few weeks a significant proportion has recurrent episodes or will develop chronic low back pain. Several mainly psychosocial risk factors for developing chronic LBP have been identified. However, effects of preventive interventions aiming at behavioural risk factors and unfavourable cognitions have yielded inconsistent results. Risk tailored interventions may provide a cost efficient and effective means to take systematic account of the individual risk factors but evidence is lacking., Methods/design: This study will be a cluster-randomised controlled trial comparing screening and a subsequent risk tailored intervention for patients with low back pain to prevent chronic low back pain compared to treatment as usual in primary care. A total of 600 patients from 20 practices in each study arm will be recruited in Berlin and Goettingen. The intervention comprises the following elements: Patients will be assigned to one of four risk groups based on a screening questionnaire. Subsequently they receive an educational intervention including information and counselling tailored to the risk group. A telephone/email consulting service for back pain related problems are offered independent of risk group assignment. The primary outcomes will be functional capacity and sick leave., Discussion: This trial will evaluate the effectiveness of screening for risk factors for chronic low back pain followed by a risk tailored intervention to prevent chronic low back pain. This trial will contribute new evidence regarding the flexible use of individual physical and psychosocial risk factors in general practice., Trial Registration: ISRCTN 68205910.