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

Universitat de Lleida

Status: Not yet enrolling

Conditions: Exercise Training; Dual Task Exercises in Elderly People; Frailty; Frail Elderly

Treatments: Behavioral: Otago exercise; Behavioral: Dual task exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT07205016

FreeFrail Project

Details and patient eligibility

About

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.

Enrollment: 220 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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220 participants in 2 patient groups

Experimental

Experimental group

Description:

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

Treatment:

Behavioral: Dual task exercise

Control

Active Comparator group

Description:

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

Treatment:

Behavioral: Otago exercise