Authors' objectives: Older adults with multimorbidity experience impaired health-related quality of life and treatment burden. Yoga has the potential to improve several aspects of health and well-being. The British Wheel of Yoga’s Gentle Years Yoga© programme was developed specifically for older adults, including those with chronic conditions. A pilot trial demonstrated feasibility of using Gentle Years Yoga in this population, but there was limited evidence of its effectiveness and cost-effectiveness. To determine the effectiveness and cost-effectiveness of the Gentle Years Yoga programme in addition to usual care versus usual care alone in older adults with multimorbidity. Multimorbidity, having two or more chronic health conditions, is a major challenge for older adults and increases healthcare utilisation and associated costs. Multimorbidity is associated with reduced health-related quality of life (HRQoL), impaired functional status, worse physical and mental health and premature death. In 2015, 54% of people aged 65 years and over in England had multimorbidity. There has been limited exploration of the effectiveness of interventions to improve outcomes for people with multimorbidity. There is some evidence to suggest that yoga may help to prevent and treat various physical and mental illnesses and improve HRQoL. The available data offer support for the beneficial effects of yoga in older adults and for several chronic conditions. However, robust evidence of clinical and cost effectiveness is limited, and little research has specifically focused on older adults with multimorbidity. The Gentle Years Yoga (GYY) programme was developed to cater specifically to the needs of older adults, including those with health conditions common to an older cohort such as osteoarthritis, hypertension and cognitive impairment. A pilot randomised trial of the GYY programme (n = 52 adults, mean age 75 years) demonstrated feasibility, with a potential for a clinically important benefit on health status [EuroQol-5 Dimensions, five-level version (EQ-5D-5L) utility index score] at 3 months after randomisation [mean difference 0.12, 95% confidence interval (CI) 0.03 to 0.21]. Consequently, we conducted this larger trial, as if shown to be clinically and cost-effective, GYY could be widely implemented, leading to improved outcomes for this population. The primary objective was to establish if the offer of a 12-week GYY programme in addition to usual care is more effective compared with usual care alone in improving HRQoL (EQ-5D-5L utility index score) over 12 months in people aged 65 years or over with multimorbidity. Secondary objectives were to: explore the effect of the GYY programme on HRQoL, depression, anxiety, loneliness and incidence of falls explore the safety of the GYY programme in terms of the occurrence of adverse events assess the cost-effectiveness of the GYY programme undertake a qualitative process evaluation to explore the acceptability of the intervention and the experience of participants and teachers, explain the determinants of delivery and identify the optimal implementation strategies.

Authors' results and conclusions: The mean age of the 454 randomised participants was 73.5 years; 60.6% were female, and participants had a median of three chronic conditions. The primary analysis included 422 participants (intervention, n = 227 of 240, 94.6%; usual care, n = 195 of 214, 91.1%). There was no statistically or clinically significant difference in the EuroQol-5 Dimensions, five-level version utility index score over 12 months: the predicted mean score for the intervention group was 0.729 (95% confidence interval 0.712 to 0.747) and for usual care it was 0.710 [95% confidence interval (CI) 0.691 to 0.729], with an adjusted mean difference of 0.020 favouring intervention (95% CI −0.006 to 0.045, p = 0.14). No statistically significant differences were observed in secondary outcomes, except for the pain items of the Patient-Reported Outcomes Measurement Information System-29. No serious, related adverse events were reported. The intervention cost £80.85 more per participant (95% CI £76.73 to £84.97) than usual care, generated an additional 0.0178 quality-adjusted life-years per participant (95% CI 0.0175 to 0.0180) and had a 79% probability of being cost-effective at the National Institute for Health and Care Excellence threshold of £20,000 per quality-adjusted life-year gained. The intervention was acceptable to participants, with seven courses delivered face to face and 12 online. Although the Gentle Years Yoga programme was not associated with any statistically significant benefits in terms of health-related quality of life, mental health, loneliness or falls, the intervention was safe, acceptable to most participants and highly valued by some. The economic evaluation suggests that the intervention could be cost-effective. Between July 2019 and August 2021, 13,070 invitation packs were sent to potentially eligible participants, of which 1297 responded. Of these, 454 (35.0%) participants were randomised: 240 to the intervention and 214 to usual care. The mean age of participants was 73.5 years (range 65–99); 60.6% were female, and participants had a median of three chronic conditions. Among the intervention group, the mean number of GYY sessions attended was 8.8 (SD 3.7, median 10, range 0–12). Two hundred and twenty-two (92.5%) participants attended at least one session, and fifty-three (22.1%) attended all twelve. Eighty per cent (n = 192) attended at least three of the first six sessions and at least three other sessions. One participant in the usual care group was invited to attend classes in error; they attended eight sessions, including five of the first six. The primary analysis included 422 participants with valid EQ-5D-5L data at baseline and at least one post-randomisation time point (intervention n = 227 of 240, 94.6%; usual care n = 195 of 214, 91.1%). There was no statistically or clinically significant difference in the EQ-5D-5L utility index score over 12 months: the predicted mean score for the intervention group was 0.729 (95% CI 0.712 to 0.747) and for usual care was 0.710 (95% CI 0.691 to 0.729), with an adjusted mean difference of 0.020 favouring intervention (95% CI −0.006 to 0.045; p = 0.14). The sensitivity analyses produced very similar results. The CACE analyses, which considered compliance as attending (1) ≥1 GYY session and (2) ≥6 including 3 of the first 6, produced slightly greater, but not clinically relevant, treatment estimates (0.025, 95% CI −0.002 to 0.052; p = 0.07; and 0.029, 95% CI −0.002 to 0.059; p = 0.06, respectively). There was no evidence of an interaction between trial arm and intended mode of delivery (interaction effect 0.007, 95% CI −0.042 to 0.057; p = 0.77). No statistically significant differences were observed in secondary outcomes, except in the T-score for the pain interference subscale of the PROMIS-29 at 3 months (−1.44, 95% CI −2.63 to −0.26; p = 0.02) and over the 12 months (−1.14, 95% CI −2.24 to −0.04; p = 0.04), and in the global (pain intensity) PROMIS-29 item at 12 months (−0.45, 95% CI −0.83 to −0.08; p = 0.02) and over the 12 months (−0.32, 95% CI −0.61 to −0.04; p = 0.03), favouring intervention. No serious, related adverse events were reported. Economic evaluation The base-case economic evaluation found that the intervention cost £80.85 more per participant (95% CI £76.73 to £84.97) than usual care, generated an additional 0.0178 QALYs per participant (95% CI 0.0175 to 0.0180) and had a 79% probability of being cost-effective at the willingness-to-pay threshold of £20,000 per QALY gained. The offer of a 12-week GYY programme was not associated with any statistically significant benefits in terms of HRQoL, mental health, loneliness or falls in older adults with multimorbidity. However, the intervention was safe, acceptable to most participants and highly valued by some. The economic evaluation suggests that the intervention could be cost-effective.

Authors' methods: Pragmatic, multisite, individually randomised controlled trial with embedded economic and process evaluations. Participants were recruited from 15 general practices in England and Wales from July 2019 with final follow-up in October 2022. Community-dwelling adults aged 65 years and over with multimorbidity, defined as two or more chronic health conditions from a predefined list. All participants continued with any usual care provided by primary, secondary, community and social services. The intervention group was offered a 12-week programme of Gentle Years Yoga. The primary outcome and end point were health-related quality of life measured using the EuroQol-5 Dimensions, five-level version utility index score over 12 months. Secondary outcomes were health-related quality of life, depression, anxiety, loneliness, incidence of falls, adverse events and healthcare resource use. Self-reported outcome data raise the potential for bias in an unblinded trial. The COVID-19 pandemic affected recruitment, follow-up and the mode of intervention delivery. Design This was a multisite, two-arm, parallel-group, superiority, individually randomised controlled trial comparing an experimental strategy of offering a 12-week GYY programme against a control strategy of no offer of GYY in community-dwelling people aged 65 years or over who had multimorbidity. Both trial arms continued with any usual care provided by primary, secondary, community and social services. The study also included cost-effectiveness and qualitative process evaluations. Participants were recruited from primary care general practices in the UK. General practices interested in taking part in the trial were identified with help from the NHS Clinical Research Networks and the Health and Care Research Wales Support and Delivery Centre. General practices were selected based on their proximity to yoga class venues and local transport routes. The yoga courses were delivered either face-to-face in a yoga studio, community hall or leisure centre or online via video conferencing during periods of social distancing restrictions. The trial’s yoga consultants identified yoga teachers who were eligible and potentially interested in taking part in the trial. Yoga teachers needed to have completed the British Wheel of Yoga (BWY) Qualification Level 4 Teaching GYY and have valid BWY membership and insurance. For online courses, teachers also needed to be proficient in remote teaching. Patients were eligible to join the study if they were aged 65 years or older, community-dwelling and had two or more of the predefined chronic health conditions derived from the NHS Quality and Outcomes Framework. Exclusion criteria were: inability to attend one of the GYY courses on offer; yoga practice in the previous 6 months; contraindications to yoga participation; severe mental health problem; learning disability; or being unable to provide consent and/or return the baseline questionnaire. For online classes, ineligibility also included no internet access; inability to use the internet; no suitable device; insufficient space at home; and/or no sturdy chair for use during the classes. Potential participants were identified by searching general practitioner (GP) electronic patient databases. Participating practices ran a custom-built search, based on predefined read codes, which identified patients with eligible health conditions. Potentially eligible patients were sent a recruitment pack including an information sheet and, if interested, were invited to sign and return a consent form. After the research team checked their suitability for the trial with their GP, eligible patients were asked to provide baseline data on sociodemographic measures, primary and secondary outcome measures and preferences/beliefs for the treatments on offer in the trial. Participants indicated on the consent form if they also wanted to be considered to take part in the process evaluation interviews.

Project Status: Completed

URL for project: https://www.journalslibrary.nihr.ac.uk/programmes/hta/17/94/36

Year Published: 2024

URL for published report: https://www.journalslibrary.nihr.ac.uk/hta/KPGN4216

URL for additional information: English

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: United Kingdom

DOI: 10.3310/KPGN4216

Organisation Name: NIHR Health and Social Care Delivery Program

Contact Name: Rhiannon Miller

Contact Email: rhiannon.m@prepress-projects.co.uk