Randomised controlled trial (RCT) study design for a large-scale municipal fall prevention exercise programme in community-living older women: study protocol for the Kuopio Fall Prevention Study (KFPS)

INTRODUCTION: Falls are a substantial health problem in seniors, causing fractures and being the leading cause of fatal injuries. The benefits of physical activity in fall prevention have been shown in randomised controlled trials (RCTs) in small cohorts (eg, ≤200 persons), but there is a gap between the known health effects of exercise and the large-scale implementation of effective activity in communities. Mental health and subjective well-being (SWB) should also be studied since they are strongly related to healthy ageing. Thus far, the proven efficacy of communal strategies to reduce falls and improve healthy ageing is sparse. METHODS AND ANALYSIS: In 2016, a 2-year RCT was launched in Kuopio, Finland to estimate the efficacy of a large, population-based, fall prevention exercise programme in community-living older women (born 1932–1945). Both the intervention and control group (n=457+457) receive health education. The intervention group is also offered free 6-month supervised training courses (weekly gym training and Taiji sessions), followed by a free 6-month unsupervised use of exercise facilities, as well as unsupervised low-cost exercise is also offered for another 12 months. During the whole 24-month follow-up, controls are free to pursue all their normal physical activities. Both study groups undergo the study measurements three times. Outcome measures include recording of falls, injuries, bone mineral density, changes in health and functional status and cognitive performance, deaths and SWB. Finally, the cost-effectiveness and cost–utility analysis will be conducted from the societal view. The main analyses comparing outcomes between study groups will be conducted using the intention to treat principle. ETHICS AND DISSEMINATION: The study has been reviewed and approved by the Research Ethics Committee of the Hospital District of North Savo. All regulations and measures of ethics and confidentiality are handled in accordance with the Declaration of Helsinki. TRIAL REGISTRATION NUMBER: NCT02665169; Pre-results.