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

Sponsor
Universitat de Lleida
Study ID
NCT07205016
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dual task exercise — BEHAVIORAL
    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.
  • Otago exercise — BEHAVIORAL
    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.

Study Details

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.

Key Dates

First listed
Oct 3, 2025
Start date
Jan 31, 2026
Status verified
Sep 2025
Primary completion
Jul 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
220 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental
    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
  • Active Comparator: Control
    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. The three components are delivered in a coordinated manner by a multidisciplinary team at ICS. Intervention fidelity is ensured through standardized protocols, training of professionals, and monitoring of adherence. The therapeutic physical activity program will be structured across three progressive levels-beginner, intermediate, and advanced-to accommodate varying functional capacities. Strength training will advance through incremental increases in repetitions and resistance, while balance exercises will become more challenging by reducing external support. The material for the session will be in the same room where the group is held and will include the use of weights or dumbbells, elastic bands, balls, and pikes

Primary Outcome Measure

Physical performance and functional status [ Time Frame: From enrollment to the end of treatment at 12 weeks ]

Central Contacts

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