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Personalised exercise rehabilitation for people with multiple long-term conditions: Main Trial

Personalised exercise rehabilitation for people with multiple long-term conditions: Randomised Controlled Trial with Prospective Cohort Study and social media SWAT

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN59323331
Enrollment
906
Registered
2024-10-10
Start date
2025-02-14
Completion date
Unknown
Last updated
2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple long-term conditions Other

Interventions

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)

Sponsors

University of Leicester
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Health related quality of life using the EQ-5D-5L at 3 month follow-up.

Secondary

MeasureTime frame
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

Countries

England, Scotland, United Kingdom

Contacts

Public ContactGwen Barwell
performlctu@leicester.ac.uk+44 116 223 1202

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026