TY - JOUR
T1 - Personalised Exercise-Rehabilitation FOR people with Multiple long-term conditions (PERFORM)
T2 - protocol for a randomised feasibility trial
AU - Simpson, Sharon Anne
AU - Evans, Rachael A
AU - Gilbert, Hannah Rosemary
AU - Branson, Amy
AU - Barber, Shaun
AU - McIntosh, Emma
AU - Ahmed, Zahira
AU - Dean, Sarah Gerard
AU - Doherty, Patrick Joseph
AU - Gardiner, Nikki
AU - Greaves, Colin
AU - Daw, Paulina
AU - Ibbotson, Tracy
AU - Jani, Bhautesh
AU - Jolly, Kate
AU - Mair, Frances
AU - Ormandy, Paula
AU - Smith, Susan
AU - Singh, Sally J
AU - Taylor, Rod
N1 - © Author(s) (or their employer(s)) 2024.
PY - 2024/4/5
Y1 - 2024/4/5
N2 - 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).
AB - 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).
KW - Humans
KW - Quality of Life
KW - Feasibility Studies
KW - Exercise Therapy
KW - Exercise
KW - Self-Management
KW - Cost-Benefit Analysis
KW - Randomized Controlled Trials as Topic
KW - Multicenter Studies as Topic
U2 - 10.1136/bmjopen-2023-083255
DO - 10.1136/bmjopen-2023-083255
M3 - Article
C2 - 38580370
SN - 2044-6055
VL - 14
JO - BMJ Open
JF - BMJ Open
IS - 4
M1 - e083255
ER -