NCT07205016

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: Universitat de Lleida · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Frail Elderly
• Dual Task Exercises in Elderly People
• Exercise Training
• Frailty

Interventions

Type	Name	Description
BEHAVIORAL	Dual task exercise	The intervention group will conduct the same multicomponent intervention than the control group, but adding the dual cognitive task while performing the therapeutic physical activity, which may include counting numbers backwards, in 2s, mentioning names of animals, food, countries and others. The objective of this additional condition is to stimulate cognitive and functional capacity simultaneously, increasing the complexity of the activity and the transfer to daily life activities.
BEHAVIORAL	Otago exercise	The proposed intervention is a multicomponent program designed to address frailty in community-dwelling older adults. It integrates three evidence-based domains: therapeutic physical activity, cognitive psychological intervention, and nutritional support.

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-07-01
• Completion: 2026-10-01
• First posted: 2025-10-03
• Last updated: 2025-10-03