A volunteer-supported walking programme to improve physical function in older people with restricted mobility (the POWER Study): a randomised controlled trial.

BACKGROUND: Regular physical activity has multiple health benefits, especially in older people. Therefore, the World Health Organization recommends at least 2.5 h of moderate physical activity per week. The aim of the POWER Study was to investigate whether volunteer-assisted walking improves the physical performance and health of older people. METHODS: We approached people aged 65 years and older with restricted mobility due to physical limitations and asked them to participate in this multicentre randomised controlled trial. The recruitment took place in nursing homes and the community setting. Participants randomly assigned to the intervention group were accompanied by volunteer companions for a 30-50 min walk up to three times a week for 6 months. Participants in the control group received two lectures that included health-related topics. The primary endpoint was physical function as measured with the Short Physical Performance Battery (SPPB) at baseline and 6 and 12 months. The secondary and safety endpoints were quality of life (EQ-5D-5L), fear of falling (Falls Efficacy Scale), cognitive executive function (the Clock Drawing Test), falls, hospitalisations and death. RESULTS: The sample comprised 224 participants (79% female). We failed to show superiority of the intervention with regard to physical function (SPPB) or other health outcomes in the intention-to-treat analyses. However, additional exploratory analyses suggest benefits in those who undertook regular walks. The intervention appears to be safe regarding falls. CONCLUSIONS: Regular physical activity is essential to preserve function and to improve health and quality of life. Against the background of a smaller-than-planned sample size, resulting in low power, and the interference of the COVID-19 pandemic, we suggest that community based low-threshold interventions deserve further exploration. TRIAL REGISTRATION: The trial was registered with the German Clinical Trials Register ( www.germanctr.de ), with number DRKS00015188 on 31/08/2018.

Experiences of participants of a volunteer-supported walking intervention to improve physical function of nursing home residents - a mixed methods sub-study of the POWER-project.

BACKGROUND: Regular physical activity improves physical health and mental well-being and reduces the risk of falling in older adults. The randomized controlled "Prevention by lay-assisted Outdoor-Walking in the Elderly at Risk" POWER-study investigates whether volunteer-supported outdoor-walking improves physical function and quality of life in older people living independently or in nursing homes. This sub-study explores the experiences of older participants and volunteers in relation to their physical and psychosocial well-being as well as the challenges faced by both groups. A further aim was to explore volunteers' experience with people living in nursing homes during the first pandemic lockdown (spring 2020). METHODS: The sub-study was designed as mixed-methods approach consisting of 11 individual semi-structured guide-based interviews (nursing home residents), two focus group interviews (volunteers), and a cross-sectional questionnaire survey (volunteers). The interviews were audiotaped, transcribed verbatim, and analyzed by content analysis as described by Kuckartz. Topics addressed in the interviews were triangulated by means of a questionnaire. The quantitative data were analyzed using descriptive statistics. RESULTS: Participants' evaluation of the intervention was generally positive. Nursing home residents appreciated the social interaction associated with the assisted walking, which motivated them to take part regularly, provided a sense of safety, and caused pleasure on both sides. The impact on physical health status of the nursing home residents of this sub-study varied to a large degree as reported in interviews: in some cases, an improvement in physical performance, a decrease in physical complaints, and an improvement in gait or independence was reported. If not, reference was made to previous or sudden illnesses and the advanced age of the participants. Despite the COVID-19-lockdown and the associated restrictions, about 60% of contacts were still possible and participants planned to continue the assisted walks after the lockdown. CONCLUSION: Volunteers have a positive effect on the quality of life, mobility, and general health of nursing home residents. Even more than the improvement of physical performance, social interaction was seen as helpful. Despite their advanced age, the nursing home residents were curious and open to new contacts. When removing the identified barriers, it might be possible to integrate this program into the long-term everyday life of nursing homes. TRIAL REGISTRATION: DRKS-ID: DRKS00015188, date of registration: 31.08.2018.

Mapping the methodological diversity of published drug discontinuation studies-a scoping review of study topics, objectives, and designs.

BACKGROUND: Trials evaluating drug discontinuation (drug discontinuation trials, DDTs) show a broad methodological spectrum. There are several specific methodological aspects in drug discontinuation trials (e.g., determination of research question; configuration of intervention; definition of outcomes). To verify this specifies, we did a scoping review about the study designs of drug discontinuation trials. METHODS: A systematic literature search in Medline (PubMed), The Cochrane Library, EMBASE, CINAHL, Web of Science, and PsycINFO was performed. In a two-step selection process, we identified DDTs, which evaluate the discontinuation of one or more long-term medication as the investigated intervention, by two independent reviewers. Besides bibliographic data, we extracted several parameters to describe the used study design of the included DDTs: motivation for DDT, initially treatment aim of the discontinued medication, study design, methods of discontinuation, follow-up times, number of study participants, and outcome parameter. RESULTS: Out of 12,132 records, we included 581 DDTs. The most common motivation for doing a DDT were expected side effects (48.8%), the motivation of proving the efficacy of medication (21.6%), or doubts on the expected benefit of the used medication (13.8%). The majority of the discontinued medication was initially prescribed to improve the prognosis of a chronic disease (60.4%) or to relieve symptoms (31%). The study designs of the trials showed a broad methodological spectrum. The minority of the drug discontinuation trials were randomized controlled trials (34%). CONCLUSION: The results of this scoping review illustrates the need for an evidence-based methodological standard for planning and conducting drug discontinuation trials.

Typology of drug discontinuation trials - Methodological recommendations.

OBJECTIVE: Due to the increasing concerns about polypharmacy, there is a growing need for clinical recommendations for drug discontinuation. This requires studies investigating the process on several levels. This paper addresses the methodological problems of drug discontinuation trials (DDTs). To that end, we offer a new typology of research aims and corresponding methodological recommendations for trials evaluating drug discontinuation. STUDY DESIGN AND SETTING: Multi-stage development process, including literature search and expert panels. RESULTS: Clinical trials are only required in cases of scientific uncertainty. We identified three situations of uncertainty associated with drug discontinuation from which we derived three study types: 1) Uncertainty regarding the effectiveness and/or safety of a drug; 2) Uncertainty regarding the procedure of discontinuing a previously taken drug; 3) Uncertainty regarding the effectiveness of complex strategies used to discontinue one or more drugs. We developed specific methodological recommendations for each study type. CONCLUSION: We offer a comprehensive definition of research aims, study designs, and methodological recommendations regarding DDTs. The typology we propose can help investigators clarify their research aims and study design. The type-specific methodological recommendation should improve the quality of future drug discontinuation trials.

A volunteer-supported walking programme to improve physical function in older people (the POWER Study): study protocol for a randomised controlled trial.

BACKGROUND: Currently 21% of the German population is older than 65 years. Above this age, the risk of suffering from chronic disease and mental disorders increases rapidly. Therefore, physical inactivity is one of the most important public health concerns among older people. To address this issue, we have conceptualised and evaluated a simple and low-threshold intervention, which requires only minimal demand on the participants, targeting older people with inadequate activity levels. The aim of the POWER Study is to investigate whether volunteer-supported outdoor-walking improves physical function and quality of life in older people. METHODS/DESIGN: In a randomised, controlled interventional superiority-trial, individuals older than 65 years of age living in the community or nursing homes will be randomised into two groups. The study will be conducted in two study centres with assessments at baseline, 6 and 12 months. The intervention group will participate in a supported physical activity intervention for 6 months. An assigned volunteer will visit them three times a week for an outdoor walk between 30 and 50 min, or equivalent indoor activity. Persons in the control group will be invited to two lectures covering topics related to health. Primary endpoint is the physical function measured by the Short Physical Performance Battery (SPPB) at baseline, after 6 and 12 months. Secondary and safety endpoints will be quality of life (EQ. 5D), fear of falling (Falls Efficacy Scale), physical activity (activity diary), cognitive executive function (clock drawing test), falls requiring medical attention, hospitalisation and death. Primary analysis will be carried out by intention to treat. DISCUSSION: We expect the intervention to improve the overall health status of the participants in a wide range of health-related outcomes. If effectiveness can be shown, the intervention will close an important gap in current services for older people. We will disseminate our experiences and results in the form of informational documents (training manual) to allow municipalities and health care organisations to implement a similar intervention. TRIAL REGISTRATION: The trial was registered on 31 Aug 2018; German Clinical Trials Register (www.germanctr.de), Deutsches Register Klinischer Studien: DRKS00015188 .

Analysis of German nutrition brochures for pregnant women with evidence-based patient information criteria.

OBJECTIVE: To evaluate nutrition brochures for pregnant women in Germany based on evidence-based patient information (EBPI) criteria. METHODS: Nutrition brochures for pregnant women in Germany were collected. Brochures addressing the risk of salmonellosis, toxoplasmosis or listeriosis were analyzed by two researchers independently. RESULTS: Fifty brochures reporting any information on the risk of infection were analyzed. Most brochures did not include literature citations and only few brochures gave a risk description, predominantly verbally, which usually leads to an overestimation of the actual risk. Advertisement was present in 22% of the brochures. CONCLUSION: German nutrition brochures for pregnant women should be adapted to comply with evidence-based patient information (EBPI) criteria for achieving a better quality of the disseminated information. PRACTICE IMPLICATIONS: The findings highlight the need of high quality nutrition brochures for pregnant women, which are relevant not only for pregnant women, but also to those responsible for creating brochures, and to physicians in charge of patient information.