Department of Sport, Exercise and Rehabilitation, Northumbria University, Newcastle-upon-Tyne, UK.
York Trials Unit, Department of Health Sciences, University of York, York, UK.
Trials. 2021 Apr 12;22(1):269. doi: 10.1186/s13063-021-05217-5.
Multimorbidity is common in older adults and associated with high levels of illness burden and healthcare expenditure. The evidence base for how to manage older adults with multimorbidity is weak. Yoga might be a useful intervention because it has the potential to improve health-related quality of life, physical functioning, and several medical conditions. The British Wheel of Yoga's Gentle Years Yoga© (GYY) programme was developed specifically for older adults, including those with chronic medical conditions. Data from a pilot trial suggested feasibility of using GYY in this population, but its effectiveness and cost-effectiveness remain uncertain.
This is a multi-site, individually randomised, superiority trial with an embedded process evaluation and an economic analysis of cost-effectiveness. The trial will compare an experimental strategy of offering a 12-week GYY programme against a control strategy of no offer in community-dwelling adults aged 65 or over who have multimorbidity, defined as having two or more chronic conditions from a predefined list. The primary outcome is health-related quality of life measured using the EQ-5D-5L, the primary endpoint being the overall difference over 12 months. Both groups will continue to be able to access their usual care from primary, secondary, community, and social services. Participants, care providers, and yoga teachers will not be blinded to the allocated intervention. Outcome measures are primarily self-reported. The analysis will follow intention-to-treat principles.
This pragmatic randomised controlled trial will demonstrate if the GYY programme is an effective, cost-effective, and viable addition to the management of older adults with multimorbidity.
ISRCTN ISRCTN13567538 . Registered on 18 March 2019.
多病共存在老年人中很常见，与高疾病负担和医疗支出有关。针对多病共存的老年人的管理，其证据基础薄弱。瑜伽可能是一种有用的干预措施，因为它有可能改善与健康相关的生活质量、身体功能和多种医疗状况。英国瑜伽轮的“宁静岁月瑜伽”（GYY）课程是专为老年人，包括患有慢性疾病的老年人设计的。一项试点试验的数据表明，在这一人群中使用 GYY 是可行的，但它的有效性和成本效益仍不确定。
这是一项多站点、个体随机、优效性试验，嵌入了过程评估和成本效益的经济分析。该试验将比较一种实验策略，即提供 12 周的 GYY 课程，与一种对照策略，即不向有多种疾病（从预定义列表中选择两种或两种以上的慢性疾病）的 65 岁及以上社区居住成年人提供课程进行比较。主要结果是使用 EQ-5D-5L 测量的与健康相关的生活质量，主要终点是 12 个月的总体差异。两组都将继续能够获得初级、二级、社区和社会服务的常规护理。参与者、护理提供者和瑜伽教师将无法对分配的干预措施进行盲法。主要测量指标为自我报告。分析将遵循意向治疗原则。
这项实用的随机对照试验将证明 GYY 课程是否是多病共存的老年人管理的有效、具有成本效益和可行的补充。
ISRCTN ISRCTN13567538. 于 2019 年 3 月 18 日注册。
