PERFORM Feasibility Study
Research type
Research Study
Full title
Personalised Exercise-Rehabilitation FOR people with Multiple long-term conditions (multi-morbidity) \nPERFORM: Feasibility study \n\n
IRAS ID
321067
Contact name
Sally Singh
Contact email
Sponsor organisation
University of Leicester
ISRCTN Number
ISRCTN68786622
Duration of Study in the UK
1 years, 0 months, 30 days
Research summary
Research Summary
The current delivery of exercise-based rehabilitation programmes delivered across the UK is fundamentally limited in two important ways:\n(1)\tProvision is dominated by services targeted at cardiovascular and pulmonary conditions, with little or no availability for other LTCs.\n(2)\tExisting rehabilitation programmes are single disease in focus and not designed to consider the complex health needs of people living with multi-morbidity. Furthermore, the workforce are specialists in cardiovascular or pulmonary rehabilitation are not necessarily equipped to manage rehabilitation needs for other long-term conditions or indeed to cope with the co-occurrence of multiple conditions. Therefore, patients with multiple LTCs (alongside their cardiac or respiratory disease) do not benefit fully from a single disease focused programme as they have more complex needs spanning multiple conditions.\nWe propose an innovative integrated approach to rehabilitation that provides equity of access for people with multi-morbidity, and includes a structured programme of supervised exercise training, complex health needs assessment (including medication review), disease(s) education and self-management support: Personalised Exercise Rehabilitation FOR people with Multiple LTCs (PERFORM) intervention.\n\nThis study is comparing a personalised exercise Rehabilitation programme compared to standard of care in patients with 2 or more long term conditions which one they receive will be chosen at random.Participants will be randomised to intervention (PERFORM intervention + usual care) or control (usual care alone) The Rehab programme will be provided for 6 weeks twice weekly Participants will be expected to attend 14 study visits
Summary of Results
This feasibility study is work package 3 of the PERFORM PGfAR funded by the National Institute for Health Research with co-Chief Investigators Professor Sally Singh, University of Leicester, and Professor Rod Taylor, University of Glasgow. The feasibility study sponsor was the University of Leicester and the study was managed by the Leicester Clinical Trials Unit.
The study recruited adult patients with multimorbidity/multiple long terms conditions (MLTC) defined as 2 or more long-term conditions. Long-term conditions are those that last for years or are life-long and generally cannot be cured, only controlled with medication and therapies. People with multiple long-term health conditions may have a reduced quality of life, have more emergency hospital admissions and die at an earlier age.
It has been proven that people benefit from exercise rehabilitation which is a programme of training and therapy to help people get back, keep and improve their health. However currently most formal exercise rehabilitation programmes have only been designed for one condition, like heart or lung rehabilitation. In our work package 2, we have co-designed with stakeholders a group exercise-based rehabilitation programme (‘PERFORM’) for people with multiple and varied long-term conditions.
The duration of the PERFORM rehabilitation programme is 8 weeks. There are sessions twice a week. Sessions have a duration of ~two hours each and consists of 1 hour of exercise training and 1 hour of health and well-being self-care education. The exercise hour has a warm-up, a strength section, an aerobic section and a cool-down, and personalised exercises for the participant. The health and wellbeing sessions are delivered by trained healthcare or exercise professional with a support PowerPoint presentation and a group discussion on a different topic each week. In addition to these 16 sessions, there are two extra sessions 2 and 4 months later to promote long-term maintenance of the exercise and other health behaviours promoted by the PERFORM intervention.
The aim of this study was to test the feasibility and acceptability of the PERFORM rehabilitation programme and study design to inform a full trial to assess clinical and cost-effectiveness that will form work package 4. Measures included: ability to recruit patients to the study, keep them in the study and collect their outcomes, and achieving an acceptable level of attendance of the PERFORM intervention. The study assessed the patient acceptability of the outcomes we plan to collect in a full trial that the EQ-5D-5L, a simple self-reported questionnaire to measure an individual’s quality of life.
We met our target of recruiting 60 participants across three sites in this feasibility study. Two sites were NHS hospitals with existing pulmonary rehabilitation services (University Hospitals of Leicester, Newcastle upon Tyne NHS Foundation Trust) and the third site was ‘Reach for Health’, a community-based exercise centre in Daventry, Northamptonshire.
Participants attended a baseline visit and then a follow-up visit 3-months later. Recruitment took place from September 2023 to January 2024 with the final follow-up assessment in April 2024. Participants were randomly allocated in a 2:1 ratio to either PERFORM rehabilitation programme plus their usual care (N=-40) or usual care alone (N=20).
The 60 participants included were 57% female, and 83% white British. There was a mean age of 62 years and mean Body Mass Index (BMI) of 30.8kg/m2. 34 different long-term conditions were reported across all participants with the most common being diabetes (42%), hypertension (38%), asthma (37%), and having a painful condition (35%). The median number of long-term conditions was 4. 60% of the participants were retired, 18.0% were in full-time employment, 16.0% of the population were unable to work, and 3.9% were in part-time employment, with 1.9% of participants not employed.
The results showed that it was possible to recruit patients to take part in this study. All 60 participants were recruited into the study within the 4.5-month recruitment window. 77% of participants stayed in the study until the 3-month follow-up visit and completed the proposed main trial outcome of EQ-5D-5L. 72% of participants attended more than 9 of the 14 PERFORM intervention sessions. There were no serious adverse events reported during this study, and the main reasons given for participants not able to finish the PERFORM rehabilitation programme were lack of time.
The Programme Steering Committee confirmed that the results of the feasibility study fulfilled the pre-defined progression criteria (participant recuitment/study retention/intervention adherence) to support progression to a full UK multicentre randomised trial (WP4 and 5). The aim of the full trial is to assess the clinical and cost-effectiveness of the PERFORM intervention.
This full randomised trial seeks to recruit 20 sites across the UK that can include both NHS and non-NHS settings. The recruitment target is 604 participants who are not eligible to take part in standard heart or lung rehabilitation. These participants will be randomised 1:1 to the PERFORM rehabilitation programme plus usual care vs usual care alone. We are also recruiting 302 participants who are eligible for heart and lung rehabilitation in a prospective cohort study. These participants will not be randomised and will all go onto the PERFORM rehabilitation programme. At the time of writing this report (2nd June 2025), we have recruited 10 sites and 45 participants.
Please find further details about the full trial at https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fle.ac.uk%252Fperform%2FNBTI%2F_je_AQ%2FAQ%2Ff2820f40-e7c8-4134-b567-5f9510f80ec4%2F2%2FJPuFoacv0h&data=05%7C02%7Cedgbaston.rec%40hra.nhs.uk%7Cadb1774e0fbd4d721a6f08ddb29f4ab6%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638863119422530640%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=MZV7xXd1bKi0U1RVycvdXTCdfHqOeysT2IPwKrA0BG8%3D&reserved=0
Patient and public involvement:
The PERFORM project has established a patient advisory group (PAG) of thirteen members with lived experience of MLTC and/or participated in heart or lung rehabilitation programmes. We have sought to recruit diverse membership including people from deprived areas and ethnic minority groups. We hold PAG meetings approximately every four months, with accessible materials provided before the virtual meetings.
The PAG has shaped the PERFORM research project at every stage. PAG members directed the project team to use the term ‘multiple long-term conditions (MLTC)’ over ‘multimorbidity’ at the start of the trial. They also recommended Health Related Quality of Life as their preferred primary outcome, specifically the EQ-5D-5L. The PAG reviewed all patient-facing documents prior to ethics submission. They also provided input on the design of the PERFORM rehabilitation programme, and the feasibility study recruitment plan, data collection, and qualitative interviews.
We would like to take this opportunity to thank all of the individuals who participated in the feasibility study, including the 18 participants who were interviewed to explore their experience with taking part in the PERFORM rehabilitation programme. We also thank the research teams and Principal Investigators at the three study sites (Dan Miller, The Reach for Health Centre, Daventry; Dr Carlos Echevarria, The Newcastle upon Tyne Hospitals NHS Foundation Trust; Professor Sally Singh, University Hospitals of Leicester NHS Foundation Trust).REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
23/WM/0057
Date of REC Opinion
2 May 2023
REC opinion
Further Information Favourable Opinion