A creative dance–supported CO-OP intervention for older adults with mild cognitive impairment: an assessor-blinded, external pilot randomised controlled trial

Abstract Background In mild cognitive impairment (MCI) a clinical syndrome associated with, but not an inevitable consequence of, ageing deficits in executive function and cognitive–motor integration can compromise everyday functioning. Few rehabilitation programmes combine occupation-centred strategy training with cognitively demanding movement. This external pilot trial aimed to assess feasibility and generate preliminary effect estimates for adding graded creative dance to a Cognitive Orientation to daily Occupational Performance (CO-OP) programme in older adults with MCI. Methods Assessor-blinded external pilot randomised controlled trial (ClinicalTrials.gov NCT06644690). Twenty-six community-dwelling adults with MCI were randomised to CO-OP plus creative dance or CO-OP alone ( n = 13 per group). CO-OP comprised 24 individual sessions over 8 weeks; the experimental arm added 20–25 min of graded creative dance per session, with total session duration and therapist contact time matched across groups. Outcomes were assessed at baseline, post-intervention (8 weeks), and 3- and 6-month follow-up. The prespecified primary outcome was executive function (Trail Making Test Part B [TMT-B] completion time); secondary outcomes included global cognition (Montreal Cognitive Assessment [MoCA]), visual memory (Rey–Osterrieth Complex Figure Test [RCFT]), dual-task cognitive errors, and depressive symptoms and loneliness. Analyses used linear mixed-effects models and generalised estimating equations, with an intention-to-treat sensitivity analysis. Results Follow-up data were available for 23 participants (88% retention). No intervention-related adverse events occurred; one unrelated serious adverse event (hip fracture from a fall at home) was recorded. For the prespecified primary outcome (executive function, TMT-B), the combined programme showed no between-group advantage. In exploratory secondary analyses, global cognition (MoCA) favoured the combined programme at all post-intervention timepoints in completer analyses (large effect sizes) and after covariate adjustment (baseline score, age and sex) but was attenuated and non-significant under intention-to-treat analysis. Dual-task cognitive errors showed a significant group-by-time interaction, reflecting differing between-group trajectories. These secondary findings are hypothesis-generating. Conclusion This external pilot showed no superiority of CO-OP plus creative dance over CO-OP alone for the prespecified primary outcome (executive function). Preliminary signals for global cognition and dual-task accuracy warrant confirmation in an adequately powered definitive trial with a prespecified, clinically meaningful primary endpoint. Trial registration ClinicalTrials.gov, NCT06644690. Registered on 16 October 2024, prospectively before participant enrolment. ( https://clinicaltrials.gov/study/NCT06644690 ) Clinical trial registration ClinicalTrials.gov, NCT06644690 ( https://clinicaltrials.gov/study/NCT06644690 ).