Randomized Clinical Trial Evaluating a Spanish Healthcare Ministry-Based Intervention to Reduce Frailty in Older Adults Aged 70 to 100

What this Trial Is About

Researchers are evaluating an intervention based on the Spanish Healthcare Ministrys algorithm to reduce frailty status or improve physical function in community-dwelling older adults aged 70 and above. This multicenter randomized clinical trial includes prefrail or frail participants or those with a gait speed under 0.8 ms, aiming to assess the interventions effectiveness at the primary care level. Secondary goals include evaluating cost-effectiveness and impacts on hospitalizations, emergency visits, disability, falls, institutionalization, mortality, primary care visits, drug use, and quality of life. The study compares two groups one receiving a group multicomponent physical exercise program, nutritional intervention, and frailty training delivered by trained experts in groups of six, and a control group receiving usual care with healthy lifestyle advice. The exercise program includes balance, flexibility, strength, and power exercises, performed twice weekly for 45 minutes over two 12-week periods separated by a two-month break. Nutritional guidance is provided based on assessments, with referrals to geriatrics when needed. Participants undergo baseline assessments including Barthel index, frailty phenotype, and gait speed measurements, with follow-up visits at 3, 5, and 8 months to monitor changes. Data collection uses electronic tools ensuring secure and anonymized storage. The main outcome is the change in frailty status or physical function after 8 months, with secondary outcomes including hospitalizations, emergency visits, and mortality over one year. Adverse events are monitored throughout the trial, which is planned to conclude by March 2025.

RCT to Analyze the Efficacy of a Spanish Healthcare ministRy Based In InTervention to Reduce Frailty Status in Prefrail Older Adults