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

Abstract Background Osteoarthritis (OA) is highly prevalent in older adults and is associated with increased dementia risk. The primary aims of this pilot randomised controlled trial (RCT) were to assess the feasibility and acceptability of a 12-week multidisciplinary Healthy Body & Mind Program for individuals with OA and dementia or cognitive concerns. Health outcomes were assessed as a secondary, exploratory aim. Method Feasibility was assessed via recruitment, retention, and adherence. Acceptability was assessed using post-program interview and focus group data and analysed using the Theoretical Framework of Acceptability. Exploratory analyses were completed of health outcomes (quality of life, pain, cognition, and psychological and physical health) using repeated measures ANOVAs (group × time interaction; intervention versus control) for outcomes with complete control-group data. Results Of 27 people screened, 18 (67%; mean age = 72 ± 6 years, 16 [89%] female; mean MoCA = 19 ± 2) were randomised to the program or a wait-list control group over a six-month recruitment period. Eligibility criteria and recruitment terminology were modified during this period to support enrolment. Six participants (two intervention, four control) withdrew after randomisation but before commencement, and nine of 18 (50%) completed the program. Among completers, session attendance was 92%. Qualitative data found strong positive affective attitude toward the program, low burden, good intervention coherence, favourable opportunity costs, and improved exercise self-efficacy. Eight of nine completers said they would continue attending if the program were offered as an ongoing service. Delivery considerations for scale-up included the effect of group attrition on remaining participants and cost of expert-delivered sessions. Conclusion The program was acceptable to participants and, once commenced, delivered with good adherence, but the trial was not feasible as designed, chiefly due to challenging recruitment and pre-commencement attrition. Future trials should expand recruitment channels and pre-specify feasibility progression criteria. More flexible delivery should be tested against a standard protocol arm to avoid compromising methodological rigor. Clinical trial registration number NCT06070818; 25/09/2023 (ClinicalTrials.gov).