Department of General Practice/Family Medicine, Philipps-University of Marburg, Marburg, Germany.
Department of Human Medicine, Institute of General Practice and Family Medicine, Faculty of Health, Witten/Herdecke University, Witten, Germany.
BMC Geriatr. 2021 Jan 13;21(1):45. doi: 10.1186/s12877-020-01988-9.
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.
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.
The trial was registered on 31 Aug 2018; German Clinical Trials Register (www.germanctr.de), Deutsches Register Klinischer Studien: DRKS00015188 .
目前，德国有 21%的人口年龄在 65 岁以上。在这个年龄段以上，患慢性病和精神障碍的风险迅速增加。因此，身体活动不足是老年人最关注的公共卫生问题之一。为了解决这个问题，我们设计并评估了一种简单且低门槛的干预措施，该措施仅对参与者提出最低要求，针对活动水平不足的老年人。POWER 研究的目的是调查志愿者支持的户外散步是否能改善老年人的身体功能和生活质量。
方法/设计：在一项随机、对照的干预性优势试验中，年龄在 65 岁以上、居住在社区或养老院的个体将被随机分为两组。该研究将在两个研究中心进行，在基线、6 个月和 12 个月时进行评估。干预组将参加为期 6 个月的支持性身体活动干预。一名指定的志愿者将每周三次访问他们，进行 30 至 50 分钟的户外散步，或进行同等的室内活动。对照组的人将被邀请参加两次讲座，讲座涵盖与健康相关的主题。主要终点是基线、6 个月和 12 个月时使用短体功表现电池（SPPB）测量的身体功能。次要和安全性终点是生活质量（EQ.5D）、跌倒恐惧（跌倒效能量表）、身体活动（活动日记）、认知执行功能（时钟绘制测试）、需要医疗关注的跌倒、住院和死亡。主要分析将通过意向治疗进行。
我们预计该干预措施将在广泛的健康相关结果中改善参与者的整体健康状况。如果能够证明其有效性，该干预措施将填补当前老年人服务中的一个重要空白。我们将以信息文件（培训手册）的形式传播我们的经验和结果，以便市和卫生保健组织能够实施类似的干预措施。
该试验于 2018 年 8 月 31 日注册；德国临床试验注册（www.germanctr.de），德国临床试验注册：DRKS00015188。
