Long-term conditions Other
Conditions
Interventions
Current interventions as of 24/07/2023:
A parallel two-group randomised feasibility study with a nested process and economic evaluation. Patients will be randomly allocated to either intervention (P
Sponsors
University of Leicester
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: Current exclusion criteria as of 24/07/2023: 1. Adults =18 years old 2. Able and willing to provide informed consent 3. To be mobile (including the use of walking aids) 4. 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: 4.1. Arthritis 4.2. Asthma 4.3. Atrial fibrillation 4.4. Bronchiectasis 4.5. Cancer 4.6. Chronic kidney disease 4.7. Chronic obstructive pulmonary disease (COPD) 4.8. Connective tissue disease (pain) 4.9. Coronary heart disease 4.10. Dementia 4.11. Depression 4.12. Diabetes mellitus 4.13. Heart failure 4.14. Hypertension 4.15. Long-COVID 4.16. Multiple sclerosis 4.17. Osteoporosis 4.18. Painful condition 4.19. Parkinson’s disease 4.20. Peripheral vascular disease 4.21. Polycystic ovarian syndrome 4.22. Psychoactive substance misuse 4.23. Stroke or transient ischaemic attack 4.24. Patients could also have one of the following conditions from the list below: 4.25. Anorexia nervosa or bulimia 4.26. Anxiety 4.27. Atrial fibrillation 4.28. Chronic fatigue syndrome 4.29. Chronic liver disease 4.30. Chronic sinusitis 4.31. Diverticular disease 4.32. Endometriosis 4.33. Epilepsy 4.34. Glaucoma 4.35. Inflammatory bowel disease 4.36. Irritable bowel syndrome 4.37. Meniere’s disease 4.38. Migraines 4.39. Pernicious anaemia 4.40. Prostate disorders 4.41. Psoriasis or eczema 4.42. Schizophrenia or bipolar affective disorder 4.43. Thyroid disease 4.44. Treated constipation 4.45. Treated dyspepsia 4.46. Viral hepatitis _____ Previous 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. Two or more long terms conditions (LTC), with at least one LTC identified from work package 1 as having evidence of the beneficial benefits of exercise 5. 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 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
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 24/07/2023: 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) 4. ("ACSM’s guidelines for exercise testing and prescription 11th Ed. 2021.") to include: 4.1. Unstable cardiac disease 4.2. Current fever 4.3. Significant aortic aneurysm (more than 5.5 cm) 5. Unable to attend in-person training sessions 6. Participation in a exercised rehabilitation programme in the last 6 months. 7. Unstable psychiatric disorder that limits or disrupts group based interventions. 8. On an End of Life pathway with a prognosis of less than 12 months survival. 9. Active malignancy (on chemotherapy/radiotherapy/planned urgent surgery) 10. 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. 11. Pregnant women 12. Under 18’s 13. Living in a Nursing Home. 14. Unsafe to exercise in a group without 1:1 supervision (e.g. significant risk of falls) _____ Previous 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 9th Ed. 2014.") 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. Unstable psychiatric disorder that limits or disrupts group-based interventions 6. On an End of Life pathway with a prognosis of fewer than 12 months of survival 7. Active malignancy (on chemotherapy/radiotherapy/planned urgent surgery) 8. 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 9. Pregnant women 10. Aged under 18 years old 11. Living in a nursing home 12. Unsafe to exercise in a group without 1:1 supervision (e.g. significant risk of falls)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessing whether pre-specified progression criteria are met to progress to the full randomised trial, and assessing the clinical and cost-effectiveness of the PERFORM intervention by analysing the: 1. Proportion of recruitment target recruited, calculated as percentage recruitment target (60 participants) at the end of 4.5 months recruitment period 2. Retention at 3 months, calculated as the percentage of patients randomised with complete EQ-5D data at 3 months follow up 3. For patients randomised to the PERFORM intervention: proportion of patients achieving =60% of sessions attended at end of intervention (proportion of sessions attended will be calculated from the number of sessions attended out of the scheduled 12 sessions) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The feasibility and acceptability of data collection tools assessed by measuring the proportion of patients with complete outcome data and quality of life data at 3-month follow up and using process evaluation patient interviews at 3 months 2. Key cost drivers estimated by economic evaluation using data gathered from a specially designed resource use questionnaire as well as from an intervention costing exercise (identifying and measuring all aspects of resources used to deliver the intervention) at 3 months. All healthcare, personal social service (PSS) resources, employment data, and personal costs will be measured within this feasibility study. 3. Risks of bias/contamination via outcome blinding breaks and access to the PERFORM intervention by control group, assessed by asking research staff to keep a log of blind breaks and by asking patients in the control group as part of their follow-up assessment whether they had accessed/been exposed to any aspects of the PERFORM intervention at 3 months | — |
Countries
England, United Kingdom, Wales
Contacts
Public ContactGwen Barwell
Outcome results
None listed