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A multi-centre, parallel-group, randomised controlled trial to assess the efficacy and safety of eurythmy therapy and tai chi in comparison with standard care in chronically ill elderly patients with increased risk of falling (ENTAiER): a trial protocol
BMC Geriatrics ( IF 3.4 ) Pub Date : 2020-03-17 , DOI: 10.1186/s12877-020-1503-6
G S Kienle 1, 2 , P G Werthmann 1, 2 , B Grotejohann 3 , K Kaier 4 , I Steinbrenner 3 , S Voigt-Radloff 5, 6 , R Huber 1
Affiliation  

In elderly poeple, multimorbidity and polypharmacy increase while sensory, motor and cognitive functions decrease. Falls occur in 30% of people aged 65 years and older at least once per year, with injuries at 10–20%. Reducing falls and enhancing physical, emotional and cognitive capacities are essential for healthy aging despite chronic disease. Eurythmy therapy (EYT) and Tai Chi train balance, mobility and concentrative and sensory capacities. In eight trial sites (academic or community hospitals), 550 outpatients aged 65 years and older with chronic disease and increased risk of falling (history of imbalance, Berg Balance Scale (BBS) score ≤ 49) will be randomly assigned (1:1:1) to receive either EYT or Tai Chi (each provided in one-hour group sessions, twice, later once per week plus practice at home, for over 24 weeks) added to standard care or standard care alone. Standard care includes a detailed written recommendation on fall prevention and the visit of a primary care doctor. Seniors living a reclusive life or economically disadvantaged elderly will be particularly addressed. A motivation and communication concept supports the trial participants’ compliance with trial procedures and practicing. Public and patient representatives are involved in the planning and conduction of the trial. Falls will be documented daily in a diary by the participants. These falls as well as injuries and complications will be ascertained during monthly phone visits. The falls efficacy scale, BBS, cognition (MoCA), Mood (GDS-15), quality of life (SF12), instrumental activities of daily living (IADL), use of medical and non-medical services (FIMA) and adherence will be assessed at months 3, 6, and 12 and inner correspondence with practices (ICPH) at month 6. The trial is funded by the Federal Ministry of Education and Research (BMBF 01GL1805). This study will determine whether EYT and Tai Chi reduce falls, injurious falls, fear of falling and healthcare utilisation and improve mobility, cognition, mood, quality of life and functional independence. A reduction of fall risk and fear of falling and an improvement of mobility, autonomy, quality of life, mood, and cognition are highly relevant for older people to cope with aging and diseases and to reduce healthcare costs. www.drks.de. DRKS00016609. Registered 30th July 2019.

中文翻译:

一项多中心、平行组、随机对照试验,旨在评估优律美疗法和太极拳与标准护理相比,对跌倒风险增加的慢性病老年患者的疗效和安全性 (ENTAiER):试验方案

在老年人中,多种疾病和多重用药增加,而感觉、运动和认知功能下降。30% 的 65 岁及以上老年人每年至少发生一次跌倒事故,受伤率为 10-20%。尽管患有慢性疾病,但减少跌倒并增强身体、情感和认知能力对于健康老龄化至关重要。优律司美疗法 (EYT) 和太极训练平衡、活动能力、注意力和感觉能力。在8个试验地点(学术或社区医院),550名65岁及以上患有慢性病且跌倒风险增加(不平衡史、伯格平衡量表(BBS)评分≤49)的门诊患者将被随机分配(1:1: 1) 在标准护理或单独标准护理的基础上接受 EYT 或太极拳(每次以一小时的小组课程形式提供,两次,后来每周一次,加上在家练习,持续超过 24 周)。标准护理包括有关跌倒预防的详细书面建议以及初级保健医生的就诊。过着隐居生活的老年人或经济困难的老年人将受到特别关注。激励和沟通概念支持试验参与者遵守试验程序和练习。公众和患者代表参与试验的规划和实施。参与者每天都会在日记中记录跌倒的情况。这些跌倒、受伤和并发症将在每月的电话访问中确定。跌倒疗效量表、BBS、认知 (MoCA)、情绪 (GDS-15)、生活质量 (SF12)、工具性日常生活活动 (IADL)、医疗和非医疗服务的使用 (FIMA) 以及依从性在第 3、6 和 12 个月进行评估,并在第 6 个月进行与实践的内部对应关系 (ICPH)。该试验由联邦教育和研究部 (BMBF 01GL1805) 资助。这项研究将确定 EYT 和太极是否可以减少跌倒、受伤性跌倒、跌倒恐惧和医疗保健利用率,并改善活动能力、认知、情绪、生活质量和功能独立性。降低跌倒风险和对跌倒的恐惧,提高活动能力、自主性、生活质量、情绪和认知能力,对于老年人应对衰老和疾病以及降低医疗费用高度相关。www.drks.de。DRKS00016609。2019年7月30日注册。
更新日期:2020-04-22
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