ISRCTN13567538Completed未知
Individually randomised controlled multi-centre trial to determine the clinical and cost effectiveness of an adapted yoga programme for older adults with multimorbidity, including an embedded process evaluation
orthumbria University Newcastle0 sites454 target enrollmentStarted: March 18, 2019Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 454
Study Overview
Brief Summary
2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33845869/ (added 14/04/2021) 2023 Results article in https://doi.org/10.3310/nihropenres.13465.1 (added 16/10/2023)
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Current inclusion criteria as of 08/01/2021:
- •1. Aged 65 years or older
- •2. Community-dwelling (including sheltered housing living with support)
- •3. Have two or more chronic health conditions from the following list:
- •3.1 Arthritis: including osteoarthritis, rheumatoid arthritis, and history of shoulder, hip or knee arthroplasty for arthritis
- •3.2 Asthma or chronic obstructive pulmonary disease (COPD)
- •3.3 Atrial fibrillation
- •3.4 A diagnosis of cancer within the last 5 years
- •3.5 Cardiovascular disease: including coronary heart disease (includes angina or history of heart attack, bypass surgery or angioplasty), hypertension, heart failure, peripheral arterial disease
- •3.5 Chronic kidney disease (CKD)
- •3.6 Dementia (only if patients have capacity to provide written informed consent)
- •3.7 Depression or anxiety
- •3.8 Diabetes
- •3.9 Epilepsy
- •3.10 Fibromyalgia
- •3.11 Multiple sclerosis
- •3.12 Osteoporosis or osteopenia
- •3.13 Parkinson’s disease
- •3.14 Sensory conditions: including hearing loss, macular degeneration, cataracts, glaucoma
- •3.15 Stroke within last 5 years
- •3.16 Bowel problems: including IBS, diverticulitis, inflammatory bowel disease
- •Previous inclusion criteria:
- •1. Aged 65 years and over (on date of invitation to participate)
- •2. Community-dwelling (including sheltered living with support),
- •3. Have two or more chronic conditions from the following list:
- •3.1 Arthritis: including osteoarthritis, rheumatoid arthritis, and history of shoulder, hip or knee arthroplasty for arthritis
- •3.2 Asthma or chronic obstructive pulmonary disease (COPD)
- •3.3 Atrial fibrillation
- •3.4 A diagnosis of cancer within the last 5 years
- •3.5 Cardiovascular disease: including coronary heart disease (includes angina or history of heart attack, bypass surgery or angioplasty), hypertension, heart failure, peripheral arterial disease
- •3.5 Chronic kidney disease
- •3.6 Dementia (only if capacity to provide written informed consent)
- •3.7 Depression or anxiety
- •3.8 Diabetes
- •3.9 Epilepsy
- •3.10 Fibromyalgia
- •3.11 Multiple sclerosis
- •3.12 Osteoporosis or osteopenia
- •3.13 Parkinson’s disease
- •3.14 Sensory conditions: including hearing loss, macular degeneration, glaucoma
- •3.15 Stroke
- •3.16 Bowel conditions: including IBS, diverticulitis, inflammatory bowel disease
Exclusion Criteria
- •Current exclusion criteria as of 08/01/2021:
- •1. Inability to attend one of the yoga courses on offer
- •2. Attended yoga classes twice a month or more in in the previous 6 months
- •3. Contraindication to yoga participation (as identified by the patient’s GP)
- •4. Severe mental health problem (Schizophrenia, bipolar affective disorder or other psychotic illness)
- •5. Learning disability
- •6. Unable to read or speak English
- •7. Unable to provide consent
- •8. Unable to complete and return a valid baseline questionnaire
- •9. No more than one patient per household
- •10. Currently enrolled in another research study for which concurrent participation is deemed inappropriate (by GP or clinical co-investigator)
- •Previous exclusion criteria:
- •1. Baseline questionnaire not returned
- •2. Inability to attend one of the yoga courses on offer
- •3. Performance of yoga in the previous 6 months (defined as twice per month or more)
- •4. Contraindication to participation (as identified by the patient’s GP)
- •5. Severe mental health problem (Schizophrenia, bipolar affective disorder or other psychotic illness)
- •6. Learning disability
- •7. Unable to read or speak English
- •8. Unable to provide written informed consent
- •9. Currently enrolled in another clinical trial where concurrent participation is deemed inappropriate
- •10. No more than one participant per household may take part
Investigators
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