Personalised exercise rehabilitation for people with multiple long-term conditions: Main Trial
| ISRCTN | ISRCTN59323331 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59323331 |
| IRAS number | 340399 |
| Secondary identifying numbers | 1006, CPMS 62643 |
- Submission date
- 07/08/2024
- Registration date
- 10/10/2024
- Last edited
- 17/02/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English Summary
Background and study aims
There is an increase in the number of people who have multi-morbidity – in other words, two or more long-term conditions – such as high blood pressure, diabetes, chronic obstructive pulmonary disease (COPD), osteoporosis, asthma and Parkinson’s disease. This is due to a generally increasing life expectancy in the population. Such people can experience a reduced quality of life and have an increased risk of hospitalisation and premature death.
Previous research has shown that undertaking a supervised 8-12-week programme of exercise-based rehabilitation can improve quality of life and well-being and reduce the risk of hospital admissions of people with single long-term conditions. However, we don’t have a good understanding of the effects of exercise-based rehabilitation in people with multiple long-term conditions.
In this trial, we will be testing a personalised exercise-based rehabilitation programme called PERFORM. This was developed with patients and clinicians to specifically meet the needs of people with multiple long-term conditions. The aim is to find out whether a personalised exercise-rehabilitation programme provides different results than the standard of care patients would receive through the NHS.
The PERFORM Feasibility study was registered at ISRCTN: https://www.isrctn.com/ISRCTN68786622
Who can participate?
Patients aged 18 years and over who have two or more long-term conditions that are identified as having a potential benefit to an exercise rehabilitation programme. The trial is looking for participants who are not currently eligible for standard cardiac or pulmonary rehabilitation to go into the randomised controlled trial, and for participants who ARE eligible for standard cardiac or pulmonary rehabilitation to go into the prospective cohort study.
What does the study involve?
All participants will be asked to attend an initial (baseline) research visit and a 3-month and 12-month follow-up visit.
These visits will take place at their local hospital or rehabilitation clinic and take about 2-3 hours to complete. They will include physical assessment measures such walking tests and handgrip strength. In the randomised controlled trial participants will be randomly allocated to either take part in the PERFORM exercise rehabilitation programme or continue with their usual care. Participants in the prospective cohort study will receive the PERFORM exercise rehabilitation instead of standard cardiac or pulmonary rehabilitation.
After participants have been randomised, if they are in a social media site they will be given the link to access a PERFORM Facebook group.
Participants who receive the exercise rehabilitation programme will also have the opportunity to take part in an interview that includes their thoughts on the programme, the barriers or facilitators whilst taking part and suggestions for improvement.
Participants who take part in the social media group will also have the opportunity to take part in an interview that includes their thoughts on the Facebook group, the pros and cons of using social media and suggestions for improvement.
What are the possible benefits and risks of participating?
The PERFORM rehabilitation programme is aimed to help people manage their multiple long-term health conditions and participants may experience some benefit in taking part, but this
intervention is being tested therefore benefits are not guaranteed. The information collected
may help in caring for other patients in the future.
There are minor disadvantages of taking part; these include travel to and from the research
centre and the time taken to complete the above-listed assessments.
The researchers don’t expect patients to be harmed in any way by taking part in our study, but they could experience some discomfort when completing the walking assessments. Also, if the participant is chosen to take part in the PERFORM rehabilitation programme this will involve exercise and there is a risk that they might initially have muscle soreness.
Where is the study run from?
University of Leicester (UK)
When is the study starting and how long is it expected to run for?
January 2024 to July 2027
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK)
Who is the main contact?
Prof. Sally Singh or Prof. Rod Taylor
Contact information
Scientific, Principal Investigator
Department of Respiratory Science
Biomedical Research Centre
University of Hospitals of Leicester NHS Trust
Leicester
LE3 9QP
United Kingdom
 ORCID ID |
0000-0002-9834-0366 |
|---|---|
| Phone | +44 (0)116 229 7309 |
| sally.singh@uhl-tr.nhs.uk |
Public
Leicester Clinical Trials Unit
Maurice Shock Building
University of Leicester
Leicester
LE1 7RH
United Kingdom
| Phone | +44 116 223 1202 |
|---|---|
| performlctu@leicester.ac.uk |
Study information
| Study design | Multi-centre randomized controlled trial with prospective cohort study and social media SWAT |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Fitness/sport facility, Hospital |
| Study type | Other, Quality of life |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Personalised exercise rehabilitation for people with multiple long-term conditions: Randomised Controlled Trial with Prospective Cohort Study and social media SWAT |
| Study acronym | PERFORM Main Trial |
| Study hypothesis | Patients with two or more long-term conditions who complete the PERFORM Exercise Rehabilitation Programme will have a greater improvement in their overall health, compared to patients randomised into the standard-of-care control group. Participants who are given access to the PERFORM Facebook group are more likely to stay in the study until the end and to engage with it. |
| Ethics approval(s) |
Approved 02/12/2024, South Central - Berkshire B Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)207 104 8012; berkshireb.rec@hra.nhs.uk), ref: 24/SC/0318 |
| Condition | Multiple long-term conditions |
| Intervention | The PERFORM study is a concurrent multicentre superiority RCT and prospective cohort study with embedded process and economic evaluations. The trial includes an additional study within a trial (SWAT) to test if providing study patients access to social media will improve their retention in the study. Study sites will be allocated 1:1 prior to recruitment to be social media sites or control sites. In the RCT, participants will be randomised to intervention (PERFORM rehabilitation programme + usual care) or control (usual care alone). In the PCS, participants will all receive the PERFORM rehabilitation programme. All participants will have a baseline assessment visit, a 3-month follow-up visit and a 12-month follow-up visit. The PERFORM rehabilitation programme intervention takes place in between the baseline visit and 3-month follow-up. The PERFORM intervention comprises of an 8 week supervised rehabilitation programme with sessions twice a week (16 sessions total). Each session will last for 2 hours (1hr of exercise, and 1hr patient ‘Health and Wellbeing’ self-care support session and Q&A/opportunity). The intervention will be offered within 4 weeks of randomisation. Each exercise session will offer an individually prescribed and progressed aerobic walking programme (a combination of walking (treadmill where available) and strength and resistance training. Participants will also be encouraged to complete a home exercise programme and a progress tracker. The ‘Health and Wellbeing’ self-care support sessions will offer advice and support for behaviour change to support positive lifestyle changes and symptom management. Much of the advice will be appropriate to all participants, but there will also be packages of advice that will only be specific to certain groups. The information will be supplemented by written leaflets and material to support the individual to share with their family and carers. Participants in the social media sites will be offered a link to a closed and secure Facebook group offering peer support and trial materials. There will be 2 separate groups, one for participants in the intervention arm and one for usual care participants |
| Intervention type | Behavioural |
| Primary outcome measure | Health related quality of life using the EQ-5D-5L at 3 month follow-up. |
| Secondary outcome measures | Measured at the 3-month and 12-month follow-up visits. 1. HRQoL: EuroQoL (EQ-5D-5L) VAS 2. Exercise/functional capacity: incremental shuttle walk test (ISWT) 3. Endurance Shuttle Walk Test 4. 4 Metre Gait Speed (MGS) 5. Strength: Hand Grip Strength 6. Mood: Patient Health Questionnaire-9 (PHQ-9) 7. Generalised Anxiety Disorder Assessment-7 (GAD-7) 8. Physical activity: International Physical Activity Questionnaire (IPAQ) 9. Frailty: Functional Assessment of Chronic Illness Therapy; Fried Exhaustion and Weight Loss 10. Fatigue (FACIT-F) 11. Pain: Brief Pain Inventory (BPI) 12. Breathlessness: Dyspnoea-12 13. Sleep: Medical Outcome Study Sleep Scale (MOS Sleep Scale) 14. Multimorbidity Treatment Burden Questionnaire (MTBQ) 15. ICEpop CAPability Measures for Adults (ICECAP-A) 16. Exercise adherence: Exercise Adherence Rating Scale (EARS) 17. Hospitalisations and overnight hospital admissions at 12 months 18. Clinical events – mortality, primary care contacts, and social and healthcare utilisation including medication |
| Overall study start date | 05/01/2024 |
| Overall study end date | 06/07/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 906 |
| Participant inclusion criteria | 1. Adults ≥18 years old 2. Able and willing to provide informed consent 3. To be mobile (including the use of walking aids) 4. Breathlessness symptoms when hurrying on level ground or walking up a slight hill (adapted from MRC 2 or above) 5. 2 or more long terms conditions from the lists below– with at least one LTC identified from work package 1 as having evidence of the beneficial benefits of exercise. The data identified that individuals must have a diagnosis of at least one of the following: 5.1. Arthritis 5.2. Asthma 5.3. Atrial fibrillation 5.4. Bronchiectasis 5.5. Cancer 5.6. Chronic kidney disease 5.7. Chronic obstructive pulmonary disease (COPD) 5.8. Connective tissue disease (pain) 5.9. Coronary heart disease 5.10. Dementia 5.11. Depression 5.12. Diabetes mellitus 5.13. Heart failure 5.14. Hypertension 5.15. Long-COVID 5.16. Multiple sclerosis 5.17. Osteoporosis 5.18. Painful condition 5.19. Parkinson’s disease 5.20. Peripheral vascular disease 5.21. Polycystic ovarian syndrome 5.22. Psychoactive substance misuse 5.23. Stroke or transient ischaemic attack 5.24. Patients could also have one of the following conditions from the list below: 5.25. Anorexia nervosa or bulimia 5.26. Anxiety 5.27. Chronic fatigue syndrome 5.28. Chronic liver disease 5.29. Chronic sinusitis 5.30. Diverticular disease 5.31. Endometriosis 5.32. Epilepsy 5.33. Glaucoma 5.34. Inflammatory bowel disease 5.35. Irritable bowel syndrome 5.36. Meniere’s disease 5.37. Migraines 5.38. Pernicious anaemia 5.39. Prostate disorders 5.40. Psoriasis or eczema 5.41. Schizophrenia or bipolar affective disorder 5.42. Thyroid disease 5.43. Treated constipation 5.44. Treated dyspepsia 5.45. Viral hepatitis |
| Participant exclusion criteria | 1. Unable to give consent for the study 2. Unable to communicate in English (carer or support worker may be available) 3. Known contraindications to exercise (as defined by the American College of Sports Medicine) ("ACSM’s guidelines for exercise testing and prescription 11th Ed. 2021.") to include 3.1. Unstable cardiac disease 3.2. Current fever 3.3. Significant aortic aneurysm (more than 5.5 cm) 4. Unable to attend in-person training sessions 5. Participation in an exercise rehabilitation programme in the last 6 months 6. Unstable psychiatric disorder that limits or disrupts group-based interventions 7. On an End of Life pathway with a prognosis of less than 12 months survival 8. Active malignancy (on chemotherapy/radiotherapy/planned urgent surgery) 9. For people on a surgical waiting list a pragmatic decision will be made on a case-by-case basis of the type of surgery, urgency and likely wait times 10. Pregnancy 11. Under 18’s 12. Living in a Nursing Home. 13. Unsafe to exercise in a group without 1:1 supervision (e.g. significant risk of falls, significant psychiatric issues) 14. Greater than 80% predicted on the ISWT at initial assessment |
| Recruitment start date | 14/02/2025 |
| Recruitment end date | 06/07/2026 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
Study participating centres
Infirmary Square
Leicester
LE1 5WW
United Kingdom
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
Daventry
NN11 4UD
United Kingdom
Wigginton Road
York
YO31 8HE
United Kingdom
Beacon Technology Park
Dunmere Road
Bodmin
PL31 2QN
United Kingdom
Adelaide Terrace
Newcastle upon Tyne
NE4 8BE
United Kingdom
Walsall
WS2 8AB
United Kingdom
Luton
LU1 3JU
United Kingdom
200 Mount Gould Road
Plymouth
PL4 7PY
United Kingdom
Charles Hastings Way
Worcester
WR5 1JR
United Kingdom
Lewes
BN7 2XG
United Kingdom
Lewes
BN7 2LG
United Kingdom
Glasgow
G12 8QQ
United Kingdom
Sponsor information
University/education
Research Governance Office
Academic Departments
Leicester General Hospital
Leicester
LE5 4PW
England
United Kingdom
| Phone | +44 (0)1162584099 |
|---|---|
| rgosponsor@leicester.ac.uk | |
| Website | https://www.nhs.uk/Services/hospitals/Services/Service/DefaultView.aspx?id=288606 |
"ROR" |
https://ror.org/04h699437 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/05/2029 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publications in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request PERFORMLCTU@leicester.ac.uk |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 1.0 | 07/08/2024 | 08/08/2024 | No | No |
Additional files
Editorial Notes
17/02/2025: The recruitment start date was changed from 10/02/2025 to 14/02/2025.
28/01/2025: The recruitment start date was changed from 06/01/2025 to 10/02/2025.
27/12/2024: The following changes were made to the study record:
1. Ethics approval details added.
2. The recruitment start date was changed from 07/10/2024 to 06/01/2025.
3. The recruitment end date was changed from 30/04/2027 to 06/07/2026.
4. The overall study end date was changed from 30/04/2028 to 06/07/2027.
08/08/2024: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
