The Gentle Years Yoga Trial
- Conditions
- Two or more chronic health conditions in people aged over 65 yearsNot ApplicableMulti-morbidity
- Registration Number
- ISRCTN13567538
- Lead Sponsor
- orthumbria University Newcastle
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 454
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Health-related quality of life as measured by the EQ-5D-5L utility score assessed at baseline, and 3, 6 and 12 months after randomisation, and the primary endpoint will be the overall difference over the 12 months.
- Secondary Outcome Measures
Name Time Method 1. Health-related quality of life measured using the EQ-5D-5L utility score at each of the individual time points (3, 6, and 12 months)<br>2. Depression measured using the PHQ-8 at 3, 6, 12 months and overall<br>3. Anxiety measured using the GAD-7 at 3, 6, 12 months and overall<br>4. Health-related quality of life measured using the PROMIS-29 at 3, 6, 12 months and overall<br>5. Loneliness measured using the UCLA 3-Item Loneliness Scale and a direct loneliness question from the English Longitudinal Study of Ageing at 3, 6, 12 months and overall<br>6. Incidence of falls over the 12 months of follow-up, assessed using a question on the number of falls experienced at 3, 6 and 12 months<br>7. Incidence of adverse events over the 12 months of follow-up<br>8. Healthcare resource use (including prescriptions) over the 12 months of follow-up, assessed via self-report questionnaire at 3, 6 and 12 months