J Am Geriatr Soc. 2025 Dec 28. doi: 10.1111/jgs.70266. Online ahead of print.
ABSTRACT
OBJECTIVES: Frailty is a common condition in community-dwelling older adults with high health and socioeconomic implications. However, primary care-led randomized trials have been scarcely tested.
DESIGN: Multicenter cluster randomized clinical trial.
SETTING AND PARTICIPANTS: Two hundred and seventy-three community-dwelling older adults recruited from 12 Spanish primary care centers.
INCLUSION CRITERIA: independence in basic activities of daily living and either prefrailty/frailty using the frailty phenotype or gait speed < 0.8 m/s.
METHODS: Participants were randomized 1:1 by clusters to the intervention or the control group, each cluster being a different primary care center.
INTERVENTION: Physical exercise program, nutritional recommendations, and frailty training to primary care professionals. Interventions were conducted based on the guidelines of the “Consensus document on the prevention of frailty in older adults,” updated in 2022, from the Spanish Health Ministry.
CONTROL: Usual care.
MAIN OUTCOME: Improvement in one category of the frailty phenotype or one point in the Short Physical Performance Battery (SPPB) at 12 and 32 weeks. under Intention-to-treat analysis was conducted.
RESULTS: Mean age 78.1 years, 68.4% female. 25.7% were frail and 74.3% prefrail or with a gait speed lower than 0.8 m/s. The percentage of participants improving the main outcome at week 12 for the intervention and control groups were 70.4% and 49.5%, respectively, absolute risk reduction (ARR) 20.9% (95% confidence interval [CI] 7.3%-34.5%; p < 0.01; n = 191), number needed to treat (NNT) 4.8 (95% CI 2.9-13.6). At 32 weeks of follow-up 81.7% and 51.9% of the intervention and control group improved, respectively, ARR 29.8% (95% CI 13.8%-45.7%; p < 0.001; n = 134), NNT 3.4 (95% CI 2.2-7.2).
CONCLUSIONS AND IMPLICATIONS: A primary care-led intervention consisting of a physical exercise program, nutritional recommendations, and training in frailty was feasible and effective for improving frailty status or physical function in community-dwelling older adults with prefrailty or frailty.
TRIAL REGISTRATION: clinicaltrial.gov: NCT05002439 (18/JUN/2021).
PMID:41456342 | DOI:10.1111/jgs.70266
