Yoga for older adults with multimorbidity (the Gentle Years Yoga Trial): study protocol for a randomised controlled trial

Background: Multimorbidity is common in older adults and associated with high levels of illness burden and healthcare expenditure. The evidence base for how to manage older adults with multimorbidity is weak. Yoga might be a useful intervention because it has the potential to improve health-related quality of life, physical functioning, and several medical conditions. The British Wheel of Yoga’s Gentle Years Yoga© (GYY) programme was developed specifically for older adults, including those with chronic medical conditions. Data from a pilot trial suggested feasibility of using GYY in this population, but its effectiveness and cost-effectiveness remain uncertain. Methods: This is a multi-site, individually randomised, superiority trial with an embedded process evaluation and an economic analysis of cost-effectiveness. The trial will compare an experimental strategy of offering a 12-week GYY programme against a control strategy of no offer in community-dwelling adults aged 65 or over who have multimorbidity, defined as having two or more chronic conditions from a predefined list. The primary outcome is health-related quality of life measured using the EQ-5D-5L, the primary endpoint being the overall difference over 12 months. Both groups will continue to be able to access their usual care from primary, secondary, community, and social services. Participants, care providers, and yoga teachers will not be blinded to the allocated intervention. Outcome measures are primarily self-reported. The analysis will follow intention-to-treat principles. Discussion: This pragmatic randomised controlled trial will demonstrate if the GYY programme is an effective, costeffective, and viable addition to the management of older adults with multimorbidity. Trial registration: ISRCTN ISRCTN13567538. Registered on 18 March 2019 Keywords: Aged, Multimorbidity, Mind-body therapies, Health-related quality of life, Randomised controlled tria

A 2x2 randomised factorial SWAT of the use of a pen and small, financial incentive to improve recruitment rates in a randomised controlled trial of yoga for older adults with multimorbidity

Background: Monetary and other incentives may increase recruitment to randomised controlled trials. Methods: 2x2 factorial ‘study within a trial’ of including a pen and/or £5 with a postal recruitment pack to improve randomisation rate (primary outcome) into the host Gentle Years Yoga trial in older adults with multimorbidity. Secondary outcomes: return, and time to return, of screening form, and the cost per additional participant recruited. Binary data were analysed using logistic regression and time to return data using Cox proportional hazards regression. Results: 818 potential host trial participants included. Between those sent a pen (n=409) and not sent a pen (n=409), there was no evidence of a difference in the likelihood of being randomised (15 (3.7%) versus 11 (2.7%); OR 1.38, 95% CI 0.63–3.04), in returning a screening form (66 (16.1%) versus 61 (14.9%); OR 1.10, 95% CI 0.75–1.61) nor in time to return the screening form (HR 1.09, 95% CI 0.77–1.55). There was evidence of improved screening return rates (77 (18.8%) versus 50 (12.2%); OR 1.67, 95% CI 1.13–2.45) and time to return screening form (HR 1.56, 95% CI 1.09–2.22) but not randomisation (14 (3.4%) versus 12 (2.9%); OR 1.18, 95% CI 0.54–2.57) in those sent £5 (n=409) compared with those not sent £5 (n=409). No significant interaction effects between the interventions were observed. The cost per additional participant recruited was £32 for the pen and £1000 for the £5 incentive. Conclusion: Including a small, monetary incentive encouraged increased and faster response to the recruitment invitation but did not result in more participants being randomised into the host trial. Since it is relatively costly, we do not recommend this intervention for use to increase recruitment in this population. Pens are cheaper but did not provide evidence of benefit. Further studies may be required. Registration: Gentle Years Yoga Trial registered on 18 March 2019, ISRCTN13567538; SWAT registered with the Northern Ireland Network for Trials Methodology Research SWAT repository on 1 April 2018, SWAT94. Funding: The GYY trial and SWATs were funded by the United Kingdom National Health Service (NHS) through the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme, open call project number 17/94/36. Keywords: study within a trial, pen, financial incentive, recruitment, factorial, randomised controlled trial, older people, multimorbidit

Effectiveness and cost-effectiveness of offering a chair-based yoga programme in addition to usual care in older adults with multiple long-term conditions : a pragmatic, parallel group, open label, randomised controlled trial

Background People with multiple long-term conditions are more likely to have poorer health-related quality of life (HRQOL). Yoga has the potential to improve HRQOL. Gentle Years Yoga© (GYY) is a chair-based yoga programme for older adults. We investigated the effectiveness and cost-effectiveness of the GYY programme in older adults with multiple long-term conditions. Methods In this pragmatic, multi-site, open, randomised controlled trial, we recruited older adults aged ≥65 years with ≥2 long-term conditions from 15 primary care practices in England and Wales. Participants were randomly assigned to usual care control or a 12-week, group-based, GYY programme delivered face-to-face or online by qualified yoga teachers. The primary outcome was HRQOL (assessed with EQ-5D-5L) over 12 months. Secondary outcomes included anxiety, depression, falls, loneliness, healthcare resource use, and adverse events. Results Between October 2019 and October 2021, 454 participants were randomly assigned to the intervention (n=240) and control (n=214) groups. Seven GYY courses were delivered face-to-face and 12 courses were delivered online. The mean number of classes attended among all intervention participants was nine (SD 4, median 10). In our intention-to-treat analysis (n=422), there was no statistically significant difference between trial groups in the primary outcome of HRQOL (adjusted difference in mean EQ-5D-5L = 0.020 [favouring intervention]; 95% CI -0.006 to 0.045, p=0.14). There were also no statistically significant differences in key secondary outcomes. No serious, related adverse events were reported. The incremental cost-effectiveness ratio was £4,546 per quality-adjusted life-year (QALY) and the intervention had a 79% probability of being cost-effective at a willingness-to-pay threshold of £20,000 per QALY. Conclusions The offer of a 12-week chair-based yoga programme in addition to usual care did not improve HRQOL in older adults with multiple long-term conditions. However, the intervention was safe, acceptable, and probably cost-effective

Lateral compression type-1 fracture fixation in the elderly (L1FE). Study Protocol for a randomised controlled trial (with internal pilot) comparing the effects of INFIX surgery and non-surgical management for treating patients with Lateral Compression type-1 (LC-1) fragility fractures

Background: Lateral compression type-1 (LC-1) fragility fractures are a common, painful injury in older adults resulting in reduced mobility. The incidence of these fractures is increasing with the growing older adult population. Current standard of care is non-surgical management, however patients with this injury are at risk of long term immobility and the related complications. INFIX is a pelvic fixation device used in younger patients with high energy fractures. The device is fitted via a percutaneous technique with no external pin sites and has good purchase even in osteoporotic bone. It therefore has the potential to be well tolerated in patients with LC-1 fragility fractures. INFIX could improve patients’ ability to mobilise and reduce the risk of immobility related complications. However, there is a risk of complications related to surgery and robust evidence is required on patient outcomes. This study will investigate the clinical and cost effectiveness of surgical fixation with INFIX compared to non-surgical management of LC-1 fragility fractures in older adults. Methods: A multi-centre randomised controlled trial of 600 patients allocated 1:1 to non-surgical management or INFIX surgery. The study will have a 12-month internal pilot to assess recruitment and trial feasibility. The primary outcome will be patient quality of life over 6 months, measured by the patient reported EQ-5D-5L. Secondary outcomes will include physical function, mental health, pain, delirium, imaging assessment, resource use and complications. Discussion: The L1FE study aims to compare the clinical and cost effectiveness of surgical and non-surgical management of people aged 60 years and older with LC-1 fragility fractures. The trial is sufficiently powered and rigorously designed to inform future clinical and patient decision making and allocation of NHS resources. Trial Registration: Trial Identifier: ISRCTN16478561. Registry Name: International Standard Randomised Controlled Trial Number Registry. Registered: 8th April 201

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