Division of Rehabilitation and Ageing. Medical School, University of Nottingham, Nottingham, UK.
Duncan McMillan House, Nottinghamshire Healthcare NHS Foundation Trust, Nottingham, UK.
BMC Geriatr. 2018 Apr 3;18(1):82. doi: 10.1186/s12877-018-0769-4.
Some older people who find standard exercise programmes too strenuous may be encouraged to exercise while remaining seated - chair based exercises (CBE). We previously developed a consensus CBE programme (CCBE) following a modified Delphi process. We firstly needed to test the feasibility and acceptability of this treatment approach and explore how best to evaluate it before undertaking a definitive trial.
A feasibility study with a cluster randomised controlled trial component was undertaken to 1. Examine the acceptability, feasibility and tolerability of the intervention and 2. Assess the feasibility of running a trial across 12 community settings (4 day centres, 4 care homes, 4 community groups). Centres were randomised to either CCBE, group reminiscence or usual care. Outcomes were collected to assess the feasibility of the trial parameters: level of recruitment interest and eligibility, randomisation, adverse events, retention, completion of health outcomes, missing data and delivery of the CCBE. Semi- structured interviews were conducted with participants and care staff following the intervention to explore acceptability.
48% (89 out of 184 contacted) of eligible centres were interested in participating with 12 recruited purposively. 73% (94) of the 128 older people screened consented to take part with 83 older people then randomised following mobility testing. Recruitment required greater staffing levels and resources due to 49% of participants requiring a consultee declaration. There was a high dropout rate (40%) primarily due to participants no longer attending the centres. The CCBE intervention was delivered once a week in day centres and community groups and twice a week in care homes. Older people and care staff found the CCBE intervention largely acceptable.
There was a good level of interest from centres and older people and the CCBE intervention was largely welcomed. The trial design and governance procedures would need to be revised to maximise recruitment and retention. If the motivation for a future trial is physical health then this study has identified that further work to develop the CCBE delivery model is warranted to ensure it can be delivered at a frequency to elicit physiological change. If the motivation for a future trial is psychological outcomes then this study has identified that the current delivery model is feasible.
ISRCTN27271501 . Date registered: 30/01/2018.
一些觉得标准运动项目过于剧烈的老年人可能会被鼓励坐着进行运动,也就是椅上运动(CBE)。我们之前通过改良 Delphi 流程开发了一个共识椅上运动方案(CCBE)。在进行确定性试验之前,我们首先需要测试这种治疗方法的可行性和可接受性,并探索如何最好地对其进行评估。
采用聚类随机对照试验部分进行可行性研究,目的是:1. 评估干预措施的可接受性、可行性和耐受性;2. 评估在 12 个社区环境(4 个日托中心、4 个养老院、4 个社区团体)中开展试验的可行性。中心被随机分配到 CCBE、小组怀旧或常规护理组。收集结局来评估试验参数的可行性:招募意向和资格、随机化、不良事件、保留率、健康结局的完成情况、缺失数据和 CCBE 的实施情况。在干预后,对参与者和护理人员进行半结构化访谈,以探讨可接受性。
在符合条件的 184 个中心中,有 48%(89 个)表示有兴趣参与,12 个中心是有目的纳入的。在经过移动性测试后,128 名接受筛查的老年人中有 73%(94 名)同意参加,然后对 83 名老年人进行了随机分组。由于 49%的参与者需要顾问声明,招募需要更高的人员配置水平和资源。由于参与者不再参加中心活动,导致高脱落率(40%)。每周在日托中心和社区团体中进行一次 CCBE 干预,在养老院中每周进行两次。老年人和护理人员发现 CCBE 干预方案大部分是可以接受的。
中心和老年人都有很高的兴趣,CCBE 干预方案得到了广泛的欢迎。试验设计和管理程序需要修改,以最大限度地提高招募和保留率。如果未来试验的动机是身体健康,那么本研究已经确定需要进一步开发 CCBE 实施模式的工作,以确保可以按照引发生理变化的频率进行实施。如果未来试验的动机是心理结果,那么本研究已经确定目前的实施模式是可行的。
ISRCTN27271501。注册日期:2018 年 1 月 30 日。