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

FreeFrail Project: Effectiveness of a Multicomponent Intervention Including Dual-task Exercise to Increase Functionality and Cognitive Performance in Frail and Pre-frail Individuals Over 65 Years Aged in Primary Care Compared to Usual Care: Protocol for 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.

Inclusion Criteria:

• Aged 65 or older
• Frailty according to Fragil-VIG index (>0,20)
• Barthel index > 60
• Able to perform physical exercise
• Able to understand and communicate in Catalan or Spanish

Exclusion Criteria:

• Decompensated / Unstable cardiovascular disease or recent diagnosed
• Upper or lower injury with functional impairment
• Institutionalized patient.
• Terminal or tumoral processes
• People who participated in another clinical trial or exercise programme during last year
• Diagnosis of severe dementia