A pilot randomised clinical trial of a novel approach to reduce sedentary behaviour in care home residents: Feasibility and preliminary effects of the GET READY study

Care-home residents are among the most sedentary and least active of the population. We aimed to assess the feasibility, acceptability, safety, and preliminary effects of an intervention to reduce sedentary behaviour (SB) co-created with care home residents, staff, family members, and policymakers within a pilot two-armed pragmatic cluster randomized clinical trial (RCT). Four care homes from two European countries participated, and were randomly assigned to control (usual care, CG) or the Get Ready intervention (GR), delivered by a staff champion one-toone with the care home resident and a family member. A total of thirty-one residents participated (51.6% female, 82.9 (13.6) years old). GR involves six face to face sessions over a 12-week period with goal-oriented prompts for movement throughout. The feasibility and acceptability of the intervention were assessed and adverse events (AEs) were collected. The preliminary effects of the GR on SB, quality of life, fear of falling, and physical function were assessed. Means and standard deviations are presented, with the mean change from baseline to post-intervention calculated along with 95% confidence intervals. The CG smoked more, sat more, and had more functional movement difficulties than the GR at baseline. The GR intervention was feasible and acceptable to residents and staff. No AEs occurred during the intervention. GR participants showed a decrease in daily hours spent sitting/lying (Cohen’s d = 0.36) and an increase in daily hours stepping, and improvements in health-related quality of life, fear of falling, and habitual gait speed compared to usual care, but these effects need confirmation in a definitive RCT. The co-created GR was shown to be feasible and acceptable, with no AEs.