BACKGROUND: Frailty is the pre-eminent exigency of aging. Although frailty-related impairments are preventable, and multidomain interventions appear more effective than unimodal ones, the optimal components remain uncertain. METHODS: We devised multidomain interventions against physical and cognitive decline among prefrail/frail community-dwelling >= 65-year-olds and evaluated these in complementary cluster-randomized trials of efficacy and participant empowerment. The efficacy study compared approximately 3-monthly telephone consultations versus 16, 2 h sessions/year comprising communally partaken physical and cognitive training plus nutrition and disease education; the empowerment study compared the standard efficacy study multidomain intervention (sessions 1 to 10) versus an enhanced version redesigned to empower and motivate individual participants. Changes from baseline in physical, functional, and cognitive performance were measured after 6 and 12 months in the efficacy study and after 6 months in the empowerment study, with post-intervention follow-up at 9 months. Primary outcomes are as follows: Cardiovascular Health Study frailty score; gait speed; handgrip strength; and Montreal Cognitive Assessment (MoCA). Secondary outcomes are as follows: instrumental activities of daily living; metabolic equivalent of task (MET); depressed mood (Geriatric Depression Scale-5 >= 2); and malnutrition (Mini-Nutritional Assessment short-form <= 11). Intervention effects were analyzed using a generalized linear mixed model. RESULTS: Efficacy study participants (n = 1,082, 40 clusters) were 75.1 +/- 6.3 years old, 68.7% women, and 64.7% prefrail/frail; analytic clusters: 19 intervention (410/549 completed) versus 21 control (375/533 completed). Empowerment study participants (n = 440, 14 clusters) were 75.9 +/- 7.1 years old, 83.6% women, and 56.7% prefrail/frail; analytic clusters: seven intervention (209/230 completed) versus seven control (189/210 completed). The standard and enhanced multidomain interventions both reduced frailty and significantly improved aspects of physical, functional, and cognitive performance, especially among >= 75-year-olds. Standard multidomain intervention decreased depression (odds ratio 0.56, 95% confidence interval (CI) 0.32 to 0.99) and malnutrition (odds ratio 0.45, 95% CI 0.26 to 0.78) by 12 months and improved concentration at Months 6 (0.23, 95% CI 0.04 to 0.42) and 12 (0.46, 95% CI 0.22, 0.70). Participant empowerment augmented activity (4.67 MET/h, 95% CI 1.64 to 7.69) and gait speed (0.06 m/s, 95% CI 0.00 to 0.11) at 6 months, with sustained improvements in delayed recall (0.63, 95% CI 0.20 to 1.06) and MoCA performance (1.29, 95% CI 0.54 to 2.03), and less prevalent malnutrition (odds ratio 0.39, 95% CI 0.18 to 0.84), 3 months after the intervention ceased. CONCLUSIONS: Pragmatic multidomain intervention can diminish physical frailty, malnutrition, and depression and enhance cognitive performance among community-dwelling elders, especially >= 75-year-olds; this might supplement healthy aging policies, probably more effectively if participants are empowered.

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