Personalised Exercise-Rehabilitation FOR people with Multiple long-term conditions (PERFORM): protocol for a randomised feasibility trial

Simpson, Sharon Anne; Evans, Rachael A; Gilbert, Hannah Rosemary; Branson, Amy; Barber, Shaun; McIntosh, Emma; Ahmed, Zahira; Dean, Sarah Gerard; Doherty, Patrick Joseph; Gardiner, Nikki; Greaves, Colin; Daw, Paulina; Ibbotson, Tracy; Jani, Bhautesh; Jolly, Kate; Mair, Frances; Ormandy, Paula; Smith, Susan; Singh, Sally J; Taylor, Rod; Simpson, Sharon Anne; Branson, Amy; Barber, Shaun; McIntosh, Emma; Ahmed, Zahira; Gardiner, Nikki; Greaves, Colin; Daw, Paulina; Ibbotson, Tracy; Jani, Bhautesh; Ormandy, Paula; Smith, Susan; Singh, Sally J; Taylor, Rod

Abstract

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). [Abstract copyright: © Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.]

Citation

Simpson, S. A., Evans, R. A., Gilbert, H. R., Branson, A., Barber, S., McIntosh, E., …Taylor, R. (2024). Personalised Exercise-Rehabilitation FOR people with Multiple long-term conditions (PERFORM): protocol for a randomised feasibility trial. BMJ Open, 14(4), e083255. https://doi.org/10.1136/bmjopen-2023-083255

• Journal Article Type: Article
• Acceptance Date: Jan 18, 2024
• Online Publication Date: Apr 5, 2024
• Publication Date: Apr 1, 2024
• Deposit Date: Apr 23, 2024
• Publicly Available Date: Apr 23, 2024
• Journal: BMJ Open
• Publisher: BMJ Publishing Group
• Peer Reviewed: Peer Reviewed
• Volume: 14
• Issue: 4
• Pages: e083255
• DOI: https://doi.org/10.1136/bmjopen-2023-083255
• Keywords: Multicenter Studies as Topic, Quality of Life, Chronic Disease, Feasibility Studies, Exercise, QUALITATIVE RESEARCH, REHABILITATION MEDICINE, Humans, Exercise Therapy, Cost-Benefit Analysis, Randomized Controlled Trials as Topic, Self-Management, Surveys