MRC/CSO Social and Public Health Sciences Unit, University of Glasgow, Glasgow, UK
University of Leicester, Leicester, UK.
BMJ Open. 2024 Apr 5;14(4):e083255. doi: 10.1136/bmjopen-2023-083255.
Personalised Exercise-Rehabilitation FOR people with Multiple long-term conditions (PERFORM) is a research programme that seeks to develop and evaluate a comprehensive exercise-based rehabilitation intervention designed for people with multimorbidity, the presence of multiple long-term conditions (MLTCs). This paper describes the protocol for a randomised trial to assess the feasibility and acceptability of the PERFORM intervention, study design and processes.
A multicentre, parallel two-group randomised trial with individual 2:1 allocation to the PERFORM exercise-based intervention plus usual care (intervention) or usual care alone (control). The primary outcome of this feasibility trial will be to assess whether prespecified progression criteria (recruitment, retention, intervention adherence) are met to progress to the full randomised trial. The trial will be conducted across three UK sites and 60 people with MLTCs, defined as two or more LTCs, with at least one having evidence of the beneficial effect of exercise. The PERFORM intervention comprises an 8-week (twice a week for 6 weeks and once a week for 2 weeks) supervised rehabilitation programme of personalised exercise training and self-management education delivered by trained healthcare professionals followed by two maintenance sessions. Trial participants will be recruited over a 4.5-month period, and outcomes assessed at baseline (prerandomisation) and 3 months postrandomisation and include health-related quality of life, psychological well-being, symptom burden, frailty, exercise capacity, physical activity, sleep, cognition and serious adverse events. A mixed-methods process evaluation will assess acceptability, feasibility and fidelity of intervention delivery and feasibility of trial processes. An economic evaluation will assess the feasibility of data collection and estimate the costs of the PERFORM intervention.
The trial has been given favourable opinion by the West Midlands, Edgbaston Research Ethics Service (Ref: 23/WM/0057). Participants will be asked to give full, written consent to take part by trained researchers. Findings will be disseminated via journals, presentations and targeted communications to clinicians, commissioners, service users and patients and the public.
ISRCTN68786622.
2.0 (16 May 2023).
个性化运动康复治疗多种慢性病患者（PERFORM）是一项研究计划，旨在开发和评估一种综合的基于运动的康复干预措施，专为患有多种慢性病（MLTCs）的患者设计。本文介绍了一项随机试验的方案，以评估 PERFORM 干预措施的可行性和可接受性、研究设计和流程。
这是一项多中心、平行的 2:1 个体随机分组试验，将参与者分配到基于 PERFORM 的运动干预加常规护理（干预组）或仅接受常规护理（对照组）。这项可行性试验的主要结果将评估是否符合预设的进展标准（招募、保留、干预依从性），以推进到全面的随机试验。该试验将在英国的三个地点和 60 名患有 MLTCs 的患者中进行，定义为两种或两种以上的慢性病，至少有一种慢性病有运动有益效果的证据。PERFORM 干预措施包括 8 周（前 6 周每周两次，后 2 周每周一次）的个性化运动训练和自我管理教育的监督康复计划，由经过培训的医疗保健专业人员提供，随后进行两次维持课程。试验参与者将在 4.5 个月的时间内招募，在随机分组后 3 个月评估结局，包括健康相关生活质量、心理健康、症状负担、虚弱、运动能力、身体活动、睡眠、认知和严重不良事件。混合方法的过程评估将评估干预措施的可接受性、可行性和保真度，以及试验过程的可行性。经济评估将评估数据收集的可行性，并估计 PERFORM 干预措施的成本。
该试验已得到西米德兰兹、埃德巴斯顿研究伦理服务（Ref：23/WM/0057）的批准。研究人员将对参与者进行培训，要求他们书面同意参加试验。研究结果将通过期刊、演讲和针对临床医生、决策者、服务使用者和患者以及公众的定向传播进行传播。
ISRCTN68786622。
2.0（2023 年 5 月 16 日）。
