NCT07643064 Clinical Efficacy of a Multicomponent Exercise and Comprehensive Geriatric Assessment Program (FRAIL+AP) in Frail Older Adults Within Primary Care: A Randomized Controlled Trial

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This trial targets 200 participants in total. It began in 2026-05-28 with a primary completion date of 2026-12-31.

Brief Summary

Frailty is a multidimensional clinical syndrome associated with increased vulnerability to adverse health outcomes in older adults. Despite strong evidence supporting multicomponent exercise interventions, their implementation in primary care settings remains limited. This randomized controlled trial aims to evaluate the efficacy of the FRAIL+AP program, which integrates Comprehensive Geriatric Assessment (CGA) with a 12-week multicomponent exercise intervention, including visual-spatial gait retraining using the Tapiz Fisior system. The study will assess whether this intervention improves frailty status, physical performance, and functional independence, while reducing falls among community-dwelling older adults compared to standard care.

Eligibility Criteria

Inclusion Criteria: * Community-dwelling adults aged 70 years or older. * Ability and willingness to provide written informed consent. * Medical clearance to participate in low-to-moderate intensity physical exercise. * Presence of frailty or pre-frailty defined by meeting at least two of the following criteria: * Functional independence sufficient to participate in the intervention (Barthel Index \>80. * FRAIL Scale score ≥ 1. * Short Physical Performance Battery (SPPB) score \< 10. * Gait speed \< 0.8 m/s. * Timed Up and Go (TUG) test \> 12 seconds. * Registered at one of the participating primary care centers. Exclusion Criteria: * Absolute contraindications to physical exercise, including recent acute myocardial infarction, unstable angina, severe uncontrolled cardiovascular disease, or severe uncorrected aortic stenosis. * Severe cognitive impairment preventing comprehension of study procedures or exercise instructions. * Severe psychiatric disorders interfering with participation. * Absence of a legally authorized representative when required. * Severe uncontrolled behavioral disturbances. * Any acute or chronic medical condition considered by the investigators to make participation unsafe. Discontinuation Criteria: * Failure to attend the initial mandatory health education workshop. * Attendance at fewer than 6 of the 12 scheduled supervised exercise sessions. * Development of an acute medical condition that results in a temporary or permanent contraindication to physical activity. * Participant withdrawal of informed consent.

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