Objectives To investigate the effects of a 12-month home-based exercise program on functioning and falls among persons with signs of frailty.

Design A randomized controlled trial with a 1:1 allocation

Setting Home-based

Participants Home-dwelling persons aged ≥65 years meeting at least one frailty phenotype criteria (n=300).

Intervention 12-month, individually tailored, progressive and physiotherapist-supervised, physical exercise twice a week (n=150) vs. usual care (n=149).

Main outcome Measures Functional Independence Measure (FIM), Short Physical Performance Battery (SPPB), handgrip strength, instrumental activities of daily living (IADL), and self-reported falls and physical activity (other than intervention). Assessed four times at home over 12 months.

Results The mean age of the participants was 82.2 (SD 6.3), 75% were women, 61% met 1–2 frailty criteria and 39% ≥3 criteria. FIM deteriorated in both groups over 12 months, -4.1 points (95% CI: -5.6 to -2.5) in the exercise group and -6.9 (-8.4 to -2.3) in the usual care group (group p=0.014, time p<0.001, interaction p=0.56). The mean improvement in SPPB was significantly greater in the exercise group [1.6 (1.3 to 2.0)] than in the usual care group [0.01 (-0.3 to 0.3)] (group p<0.001, time p=0.11, interaction p=0.027). The exercise group reported significantly fewer falls per person-year compared to the usual care group (incidence rate ratio, IRR 0.47 [95% CI 0.40 to 0.55]; p<0.001). There was no significant difference between the groups over 12 months in terms of handgrip strength, IADL function or self-reported physical activity.

Conclusions One year of physical exercise improved physical performance and decreased the number of falls among people with signs of frailty. FIM differed between the groups at 12 months, but exercise did not prevent deterioration of FIM, IADL or handgrip strength.