Simpson, S. et al. (2024) Personalised Exercise-Rehabilitation FOR people with Multiple long-term conditions (PERFORM): protocol for a randomised feasibility trial. BMJ Open, 14(4), e083255. (doi: 10.1136/bmjopen-2023-083255) (PMID:38580370) (PMCID:PMC11002422)
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Abstract
Introduction: 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. Methods and analysis: 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. Ethics and dissemination: 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. Trial registration number: ISRCTN68786622. Protocol version 2.0 (16 May 2023).
| Item Type: | Articles |
|---|---|
| Additional Information: | SJS is partly funded by the Wellcome Doctoral Training Programme, NIHR Health Technology Assessment (grant number 131015), NIHR DHSC/UKRI COVID-19 Rapid Response Initiative, NIHR Global Research Group (NIHR 17/63/20), Actegy and is an NIHR Senior Investigator. |
| Status: | Published |
| Refereed: | Yes |
| Glasgow Author(s) Enlighten ID: | Jani, Dr Bhautesh and McIntosh, Professor Emma and Mair, Professor Frances and Simpson, Mrs Sharon and Taylor, Professor Rod and Ibbotson, Dr Tracy |
| Authors: | Simpson, S., Evans, R. A., Gilbert, H. R., Branson, A., Barber, S., McIntosh, E., Ahmed, Z., Dean, S. G., Doherty, P. J., Gardiner, N., Greaves, C., Daw, P., Ibbotson, T., Jani, B., Jolly, K., Mair, F., Ormandy, P., Smith, S., Singh, S. J., and Taylor, R. |
| College/School: | College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > General Practice and Primary Care College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > Health Economics and Health Technology Assessment College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > MRC/CSO SPHSU |
| Journal Name: | BMJ Open |
| Publisher: | BMJ Publishing Group |
| ISSN: | 2044-6055 |
| ISSN (Online): | 2044-6055 |
| Published Online: | 05 April 2024 |
| Copyright Holders: | Copyright © 2024 The Authors |
| First Published: | First published in BMJ Open 14(4):e083255 |
| Publisher Policy: | Reproduced under a Creative Commons License |
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