BACKGROUND: Physical exercise is an effective strategy for preserving functional capacity and improving the symptoms of frailty in older adults. In addition to functional gains, exercise is considered to be a cornerstone for enhancing cognitive function in frail older adults with cognitive impairment and dementia. We assessed the effects of the Vivifrail exercise intervention for functional capacity, cognition, and well-being status in community-dwelling older adults. METHODS: In a multicentre randomized controlled trial conducted in three tertiary hospitals in Spain, a total of 188 older patients with mild cognitive impairment or mild dementia (aged > 75 years) were randomly assigned to an exercise intervention (n = 88) or a usual-care, control (n = 100) group. The intervention was based on the Vivifrail tailored multicomponent exercise programme, which included resistance, balance, flexibility (3 days/week), and gait-retraining exercises (5 days/week) and was performed for three consecutive months (http://vivifrail.com). The usual-care group received habitual outpatient care. The main endpoint was change in functional capacity from baseline to 1 and 3 months, assessed with the Short Physical Performance Battery (SPPB). Secondary endpoints were changes in cognitive function and handgrip strength after 1 and 3 months, and well-being status, falls, hospital admission rate, visits to the emergency department, and mortality after 3 months. RESULTS: The Vivifrail exercise programme provided significant benefits in functional capacity over usual-care. The mean adherence to the exercise sessions was 79% in the first month and 68% in the following 2 months. The intervention group showed a mean increase (over the control group) of 0.86 points on the SPPB scale (95% confidence interval (CI) 0.32 to 1.41 points; p < 0.01) after 1 month of intervention and 1.40 points (95% CI 0.82 to 1.98 points; p < 0.001) after 3 months. Participants in the usual-care group showed no significant benefit in functional capacity (mean change of -0.17 points (95% CI -0.54 to 0.19 points) after 1 month and -0.33 points (95% CI -0.70 to 0.04 points) after 3 months), whereas the exercise intervention reversed this trend (0.69 points (95% CI 0.29 to 1.09 points) after 1 month and 1.07 points (95% CI 0.63 to 1.51 points) after 3 months). Exercise group also obtained significant benefits in cognitive function, muscle function, and depression after 3 months over control group (p < 0.05). No between-group differences were obtained in other secondary endpoints (p > 0.05). CONCLUSIONS: The Vivifrail exercise training programme is an effective and safe therapy for improving functional capacity in community-dwelling frail/prefrail older patients with mild cognitive impairment or mild dementia and also seems to have beneficial effect on cognition, muscle function, and mood status.

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