Frame fit: safety, acceptability and effectiveness of a community-based fall prevention exercise intervention for walking frame users, a randomised controlled trial

Walking frame users are at increased risk of falls due to gait and balance impairments and restrictions caused by the frame itself. While exercise is an effective fall prevention intervention in the general population, there are no programmes specific to walking frame users. Adaptations may be required for walking frame users to achieve an appropriate intensity and dose of fall prevention exercise without increasing the propensity to fall while exercising. The Frame Fit intervention is a home exercise programme adapted for the needs of frame users. The aim of this study was to evaluate safety, acceptability and effectiveness of the Frame Fit intervention. Community dwelling older people (aged ≥ 65) who use a walking frame were recruited to the randomised controlled trial and allocated to the 6-month Frame Fit intervention, a programme of home exercises prescribed and progressed by a physiotherapist, or to usual care. Falls (primary outcome) were recorded using diaries for 12 months from randomisation. Physical performance (grip strength, balance, gait speed and sit-to-stand), timed up and go, physical activity, fear of falling and health-related quality of life was measured at baseline and after six months. Secondary healthcare use and mortality was collected from electronic records for 12 months from randomisation. Of 117 participants randomised, (59 to intervention, 58 to usual care), 86 were followed up at six months and 83 provided 12 month falls data. There were two intervention-related adverse events. There were more falls reported by the intervention group than control group at six months (adj, IRR: 2.10, 95%CI 1.06–3.98) but no difference in falls at 12 months (adj.IRR:1.76, 95%CI 0.93–3.33). Adherence was satisfactory but there was low uptake to the trial. There were no differences found in the secondary outcome measures. Frame Fit intervention offered a satisfactory safety profile, was acceptable to those who participated and feasible. Due to low recruitment rates, the study was underpowered to detect a difference in falls or other outcomes. Further research is needed to optimally tailor fall prevention interventions to walking frame users. The protocol was prospectively registered as a clinical trial with the ISRCTN (clinical trial number: 57645734) on 11/09/2014.