Pilot trial of body and mind program for osteoarthritis with cognitive concerns proves acceptable but not feasible

Osteoarthritis affects a large share of older adults and is associated with an increased risk of dementia, yet few interventions have been designed for people who live with both joint disease and cognitive concerns. A team led by Claire V. Burley and Belinda J. Parmenter set out to test whether a 12-week multidisciplinary Healthy Body & Mind Program could be delivered to this group within the framework of a randomised controlled trial. The study, published in BMC Musculoskeletal Disorders, was registered as NCT06070818 and framed its primary aims around feasibility and acceptability, treating health outcomes only as a secondary, exploratory question.

The pilot randomised controlled trial enrolled adults with osteoarthritis who also had dementia or cognitive concerns. Over a six-month recruitment period, 27 people were screened and 18 were randomised, a yield of 67 percent. Participants had a mean age of 72 years, with a standard deviation of 6, and 16 of the 18, or 89 percent, were women. Their mean score on the Montreal Cognitive Assessment was 19, with a standard deviation of 2, indicating mild cognitive impairment in the range the program was designed to serve. Eligibility criteria and recruitment terminology had to be modified during the recruitment window to keep enrolment moving.

Attrition before the intervention began proved to be a defining feature of the trial. Six participants, two from the intervention arm and four from the wait-list control arm, withdrew after randomisation but before commencement. In the end, nine of the 18 randomised participants, or 50 percent, completed the program. Among those completers, session attendance reached 92 percent, showing that once people started the program they engaged with it consistently. The gap between pre-commencement withdrawal and strong post-commencement adherence became one of the central lessons of the study.

Acceptability was assessed through post-program interviews and focus group data, analysed using the Theoretical Framework of Acceptability. The qualitative findings were strongly positive. Participants showed a strong positive affective attitude toward the program, reported low burden, demonstrated good intervention coherence, found the opportunity costs favourable, and reported improved exercise self-efficacy. Eight of the nine completers said they would continue attending if the program were offered as an ongoing service, a striking endorsement from a group often underserved by standard exercise and rehabilitation services.

The trial was not feasible as designed, however. The authors attribute this chiefly to challenging recruitment and pre-commencement attrition. The effect of group attrition on remaining participants emerged as a delivery consideration for any future scale-up, alongside the cost of expert-delivered sessions. These are practical constraints that matter for anyone planning a larger trial or a clinical service in this population, because a program that participants enjoy can still fail if too few people can be enrolled and retained through the randomisation stage.

Exploratory analyses of health outcomes, including quality of life, pain, cognition, and psychological and physical health, were completed using repeated measures ANOVAs with a group-by-time interaction comparing intervention against control, but only for outcomes with complete control-group data. Because the trial was powered and designed as a feasibility study, these analyses are exploratory and should not be read as evidence of efficacy. The authors are careful on this point: the primary contribution of the work lies in what it reveals about running a trial in this population, not in any treatment effect.

The conclusion drawn by the research team is nuanced. The program was acceptable to participants and, once commenced, was delivered with good adherence. But the trial was not feasible as designed, chiefly due to challenging recruitment and pre-commencement attrition. The authors recommend that future trials expand recruitment channels and pre-specify feasibility progression criteria, so that decisions about whether to proceed to a full-scale trial are made against transparent benchmarks rather than ad hoc judgements made mid-study.

A further recommendation addresses delivery design. The authors suggest that more flexible delivery should be tested against a standard protocol arm to avoid compromising methodological rigor. This is a methodological point with broad relevance: adapting a program to improve reach is valuable, but doing so without a comparison arm risks conflating the effects of flexibility with the effects of the intervention itself. Testing flexible against standard delivery preserves the ability to attribute outcomes while still exploring whether a less rigid format might improve retention in a population where pre-commencement withdrawal was the dominant threat to the study.

For clinicians and researchers working at the intersection of musculoskeletal health and cognitive ageing, the study offers a clear picture of both promise and obstacle. The strong affective attitude, low burden, good intervention coherence, favourable opportunity costs, and improved exercise self-efficacy reported by completers suggest the program’s content resonates with its intended audience. The 92 percent attendance rate among completers reinforces that. At the same time, the 50 percent completion rate overall, driven by six withdrawals before commencement, and the need to modify eligibility criteria and recruitment terminology mid-recruitment, show that reaching and retaining this population through a formal trial structure remains the hardest part of the problem. The authors’ call for expanded recruitment channels and pre-specified feasibility criteria provides a concrete roadmap for the next iteration.

Subject of Research: Feasibility and acceptability of a pilot randomised controlled trial of a 12-week multidisciplinary program for people with osteoarthritis and cognitive concerns

Article Title: Feasibility and acceptability of a pilot randomised controlled trial for people with osteoarthritis and cognitive concerns: the healthy body & mind program

Article References: Burley, C. V., Yeates, W., Tsang, S., Riethmuller, M. L., Jones, M. D., McLeod, K. A., Borges, N., Asadi, S., Brodaty, H., & Parmenter, B. J. (2026). Feasibility and acceptability of a pilot randomised controlled trial for people with osteoarthritis and cognitive concerns: the healthy body & mind program. BMC Musculoskeletal Disorders. https://doi.org/10.1186/s12891-026-10626-1

Image Credits: AI Generated

DOI: 10.1186/s12891-026-10626-1

Keywords: osteoarthritis, cognitive concerns, dementia risk, pilot randomised controlled trial, feasibility, acceptability, exercise self-efficacy, older adults, quality of life, recruitment challenges, attrition, multidisciplinary program