BACKGROUND: Falls have a major impact on individual patients, their relatives, the healthcare system and related costs. Physical exercise programmes that include multiple categories of exercise effectively reduce the rate of falls and risk of falling among older adults. METHODS: This 12-month, assessor-blinded, three-armed multicentre randomised clinical trial was conducted in adults aged >= 65 years identified as at risk of falling. Four hundred and five participants were randomly allocated into 3 groups: experimental group (n = 166) with the Test and Exercise partially supervised programme based on empowerment delivered with a tablet, illustrated manual and cards, reference group (n = 158) with the Otago partially supervised programme prescribed by a physiotherapist delivered with an illustrated manual and control group (n = 81) with the Helsana self-administrated programme delivered with cards. Experimental and reference groups received partially supervised programmes with 8 home sessions over 6 months. Control group received a self-administered program with a unique home session. The 3 groups were requested to train independently 3 times a week for 12 months. Primary outcome was the incidence rate ratio of self-reported falls over 12 months. Secondary outcomes were fear of falling, basic functional mobility and balance, quality of life, and exercise adherence. RESULTS: A total of 141 falls occurred in the experimental group, 199 in the reference group, and 42 in the control group. Incidence rate ratios were 0.74 (95% CI 0.49 to 1.12) for the experimental group and 0.43 (95% CI 0.25 to 0.75) for the control group compared with the reference group. The Short Physical Performance Battery scores improved significantly in the experimental group (95% CI 0.05 to 0.86; p = 0.027) and in the reference group (95% CI 0.06 to 0.86; p = 0.024) compared with the control group. CONCLUSION: The self-administered home-based exercise programme showed the lowest fall incidence rate, but also the highest dropout rate of participants at high risk of falling. Both partially supervised programmes resulted in statistically significant improvements in physical performance compared with the self-administered programme. TRIAL REGISTRATION: NCT02926105. CLINICALTRIALS: gov.

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