Effectiveness of an intervention to prevent frailty in pre-frail community-dwelling older people consulting in primary care: a randomised controlled trial.

Background: evidence on the effectiveness of interventions to prevent frailty is scarce. Objective: to assess the effect of an intervention in preventing frailty progression in pre-frail older people. Study design: a randomised, open label, controlled trial with two parallel arms. Population: community-dwelling pre-frail older people (≥70 years) consulting in primary care. Intervention: nutritional assessment (and derivation to a Nutritional Unit for usual care in the event of nutritional risk) and a physical activity programme including aerobic exercise and a set of mixed strengthening, balance and coordination exercises. Control group: patients receiving the usual care. Main outcome measure: prevalence of frailty (Fried criteria) at 12 months. Secondary outcomes measures: functional capacity (Barthel index), falls and nutritional status (Short-Form Mini Nutritional Assessment) on follow-up at 12 months.
Results: one hundred and seventy-two participants were recruited and randomised (mean age: 78.3 years; mean number of Fried criteria: 1.45). Thirty-nine participants (22.6%) were dropped out during the study. At follow-up, 4.9% of the intervention group and 15.3% of the control group had evolved to frailty, for a crude odds ratio (OR) of 0.29 (95% confidence interval [CI]: 0.08-1.08; P = 0.052) and an adjusted (by age, gender and number of co-morbidities) OR of 0.19 (95% CI: 0.04-0.95; P = 0.044). Intervention group showed a higher outdoors walking hour per day (0.97 versus 0.73; P = 0.019) but no difference was observed in muscle strength, gait speed or other functional indicators.
Conclusion: an intervention focused on physical exercise and maintaining good nutritional status may be effective in preventing frailty in community-dwelling pre-frail older individuals. ClinicalTrials.gov identifier: NCT02138968.

RCT Entities:   Population Interventions Outcomes