FreeFrail Project: A Multicomponent Intervention for the Management of Frailty in Primary Care: A Randomized Controlled Trial

The primary aim is to assess the effectiveness of a multicomponent intervention including dual-task exercise in improving functionality and cognitive performance and in reducing frailty among community-dwelling adults aged ≥65 years compared to usual care. Secondary objectives include evaluating its impact on pain, anxiety or depression, sleep quality, quality of life, physical activity, handgrip strength, and polypharmacy. A double-blind, randomized, parallel-group controlled trial will be conducted in primary care centers in Lleida. Frail older adults (≥65 years) will be recruited and randomly allocated to either the intervention group, receiving a structured cognitive-motor dual-task based multicomponent program, or the control group, receiving usual care. Outcomes will be assessed using validated tools at baseline and follow-up.

NCT Number	NCT07205016
Lead Sponsor	Universitat de Lleida Collaborators: Institut Catala de Salut
Conditions	Frail Elderly, Dual Task Exercises in Elderly People, Exercise Training, Frailty
Enrollment	220 participants
Start Date	2026-01
Primary Completion	2026-07 (estimated)
Study Completion	2026-10 (estimated)
Updated on ClinicalTrials.gov	2025-10-03