Title: Frame Fit. A randomised controlled trial to determine the acceptability, safety and efficacy of a falls prevention exercise programme for walking frame users.
Funder: Health Education England

Abstract: Background Older people often start to use a walking aid as mobility, strength and functional ability declines. This may be related to a specific pathology or to more generalised frailty13. There is evidence that using a walking frame increases the risk of falling more than can be explained by the balance deficits which initiate frame use11. Exercise which include highly challenging balance training for at least 6 months, effectively prevent falls14. However, despite the increased risk associated with frame use, no trials have targeted frame users with a fall prevention exercise intervention addressing the unique challenges facing walking frame users. The frame fit study is a randomised controlled trial investigating the safety, acceptability and efficacy of a home based exercise programme for frame users. The primary outcome measure will be falls in the following year. Method Two hundred and forty participants will be recruited from King's College hospital and local GP practices if they are regular walking frame users, aged over 65 and able to complete the falls dairy and home exercise programme satisfactorily. Baseline demographics, functional ability (Barthel index15) and cognition (Addenbrooke's Cognitive Examination [ACE-R]16) will be measured and assessment of balance (standing balance rating scale 17), strength (grip strength and sit to stand 17), gait (6m walk and timed up and go18), physical activity (IPEC questionnaire19), frailty (frailty index20), fear of falling (iconographical FES-I21) and quality of life (EQ5D22) will be undertaken at baseline and 6-month follow up. In addition to this, participants will keep a diary for 1 year recording any falls and fall related injuries they sustain in that period.Participants will be randomised to either receive the intervention or usual care. The intervention involves a physiotherapist visiting the participant for 7 sessions over a 3 month period with telephone follow up and a final visit at 6 months. The physiotherapist will teach, monitor and progress a programme of home exercises designed to address challenges that frame users experience. Exercises will involve practice manoeuvring the frame, work on safe transfers using the frame and addressing dynamic balance required when it is necessary to let go of the frame. Exercises will be individually tailored and progressive aiming for the participant to carry out the programme 3 times each week. Data analysis After 6-month follow up, differences in the measures of balance, walking, fear of falling, quality of life, physical activity and frailty from baseline to follow up will be compared between the intervention and usual care group using univariate analyses paired t-tests and Chi square tests for contingency tables. An intention-to-treat approach will be used for all analyses. Significance will be set at P Following completion of the 1 year follow up for falls and injuries, data will be analysed using negative binomial regression analysis to determine differences in fall rates between the intervention and control groups. Health care costs resulting from falls in both groups and costs of delivering the intervention will be collected to conduct economic analysis at a later date. Outputs Findings will be disseminated using academic journals and conference presentations. If the intervention is effective the programme resources will be made available to physiotherapists to enable it to be widely used as part of a tailored approach to falls prevention within the general population.

Lay abstract: Falls are common among people with walking and balance difficulties, particularly those who have to use a walking frame to get around. Exercise programmes to improve balance effectively prevent falls. However, no programme has been designed to include the frame in the exercise or provided exercises to address the unique challenges to mobility and balance experienced by frame users. This project will test a fall prevention exercise programme developed specifically for frame users. Frame users will be randomly assigned to receive either this exercise or usual care. Balance, mobility and falls will then be compared between these two groups.

Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING
Health categories: INJURIES AND ACCIDENTS