An individually randomised controlled, two arm, pragmatic, 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
Four methodological studies are also embedded – Studies Within A Trial (SWATS)
Research looking into multimorbidity, defined as when a person has two or more long-term health conditions is becoming increasingly important. This is because it has been reported that up to 65% of people aged 65 and over are multimorbid, resulting in huge treatment and financial challenges for the NHS.
Due to its rising popularity and focus on promoting health and wellbeing through mental, spiritual and physical emphasis, we believe yoga may be able to relieve some of this burden. We are specifically looking at the clinical and cost effectiveness of the British Wheel of Yoga’s (BWY) Gentle Years Yoga programme compared to usual care. This 12-week yoga programme has been developed for the needs of people with age-related health conditions. If demonstrated to be clinically and cost effective, this yoga programme should be feasible for widespread delivery within the NHS.
Building on from a pilot trial which demonstrated feasibility and encouraging preliminary data, we hope to recruit 586 men and women from 12 regions across the UK on to this full-scale multi-centre trial. Eligible participants will be aged 65 and over, community-dwelling, and living with multimorbidity. Multimorbidity is defined as having two or more chronic conditions from the following list;
Arthritis: including osteoarthritis, rheumatoid arthritis, and history of shoulder, hip or knee arthroplasty for arthritis
Asthma or chronic obstructive pulmonary disease (COPD)
A diagnosis of cancer within the last 5 years
Cardiovascular disease (CVD): including coronary heart disease (includes angina, and history of heart attack, bypass surgery or angioplasty) hypertension, heart failure, peripheral arterial disease
Chronic kidney disease
Dementia (only if participant retains capacity to provide written informed consent)
Depression or anxiety
Osteoporosis or osteopenia
Sensory conditions: including hearing loss, macular degeneration, glaucoma
Stroke during the last 5 years
Bowel problems: including IBS, diverticulitis, inflammatory bowel disease
There are also some criteria preventing a patient’s recruitment onto the study. These are:
If they are unable to attend one of the yoga courses on offer
If they have attended yoga classes twice a month or more in the previous 6 months
Defined as having contraindication(s) to yoga participation (as identified by their GP)
Diagnosed with a severe mental health problem (Schizophrenia, bipolar affective disorder or other psychotic illness)
Have a learning disability
Unable to read or speak English
Unable to provide consent
Unable to complete and return a valid baseline questionnaire
They are currently enrolled in another research study for which concurrent participation is deemed inappropriate (by GP or clinical co-investigator)
No more than one patient per household may take part in the study
Control and intervention groups: will both receive usual care, which will comprise of unrestricted care from primary, secondary, community and social services.
Intervention group: This group will receive the offer of a 12-week Gentle Years Yoga programme. The yoga programme will involve weekly group-based sessions and self-managed, home-based yoga practice.
We have a three-pronged approach to recruitment.
Our main strategy will be through a mail out sent from general practices inviting people to take part. We will have approximately three recruiting practices in each of the 12 regions.
Our next strategy is through advertisement - we plan to advertise through posters and newspaper adverts.
Finally, we are going to invite participants who meet the eligibility criteria that have previously participated in trials co-ordinated by the York Trials Unit and who have consented to being approached about future research.
Objectives and outcome measures
Our primary objective is to establish what effect the BWY Gentle Years Yoga programme and usual care has on our participants’ health-related quality of life compared to usual care alone. We will measure quality of life using the EQ-5D-5L utility index score.
There are also several secondary objectives being assessed through secondary outcomes such as depression, anxiety, falls incidence, loneliness and healthcare resource use. A subset of participants and yoga teachers will also be interviewed to inform intervention implementation.
Outcomes will be collected at baseline, and 3, 6 and 12 months using postal questionnaires.
We produced a press release which was circulated on York and Northumbria University websites as well as through North News.