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

NCT07205016 | Not Yet Recruiting

• 1 other identifier: FreeFrail Project
• Study Type: interventional
• Target: 220
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

primary care Health [MeSH]; multicomponent intervention; exercise therapy [MeSH]; cognitive-motor dual-task; frail elderly [MeSH]; frailty [MeSH]

Outcome Measures

Primary Outcomes (3)

• Physical performance and functional status

  The Short Physical Performance Battery (SPPB) is an ordinal quantitative scale ranging from 0 to 12. This validated tool assesses three functional domains: lower-limb muscle strength, by timing the repeated chair-stand test; gait speed, through the 4-meter walking test; and static balance, evaluated with three progressively difficult positions (feet together, semi-tandem, tandem). A composite score is calculated, with lower values reflecting poorer performance. A score of 9 or less has been widely adopted as a cut-off point for identifying frailty and pre-frailty in older adults, making this instrument particularly suitable for evaluating the effectiveness of interventions on physical function

  From enrollment to the end of treatment at 12 weeks

• Cognitive function

  The Mini-Mental State Examination (MMSE) is a continuous quantitative widely used 30-point screening tool validated for older adults to assess global cognitive function. It evaluates orientation, memory, attention, language, and praxis, providing a standardized quantitative measure of cognitive status. Although limited in sensitivity for mild or executive deficits, the MMSE remains a practical first-line assessment in frailty research and clinical protocols, and its integration alongside multidimensional frailty measures allows for a more comprehensive characterization of cognitive vulnerability in aging. A culturally adapted and validated version is available in Spanish, enabling its use in Hispanic populations.

  From enrollment to the end of treatment at 12 weeks

• Frailty status

  The Frailty-VIG is an ordinal quantitative measure specifically validated for older adults in the community. This multidimensional tool comprises 22 dichotomous items spanning activities of daily living, nutrition, cognition, emotional health, social context, geriatric syndromes, and chronic diseases. By incorporating multimorbidity and psychosocial domains alongside physical aspects, the Frailty-VIG provides a comprehensive assessment of frailty, overcoming the limitations of purely physical indices

  From enrollment to the end of treatment at 12 weeks

Secondary Outcomes (5)

• Quality of life / Anxiety and Depression / Pain severity

  From enrollment to the end of treatment at 12 weeks

• Sleep performance

  From enrollment to the end of treatment at 12 weeks

• Physical activity

  From enrollment to the end of treatment at 12 weeks

• Handgrip strength

  From enrollment to the end of treatment at 12 weeks

• Inflammatory and mitochondrial function biomarkers

  From enrollment to the end of treatment at 12 weeks

Study Arms (2)

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

Behavioral: Dual task exercise

Control

ACTIVE COMPARATOR

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

Behavioral: Otago exercise

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.

Experimental

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.

Control

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitat de Lleida: lead
• Institut Catala de Salut: collaborator

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Oriol Martínez-Navarro, Doctor

CONTACT

619562618; oriol.martinez@udl.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: A double-blind, randomized, parallel-group controlled trial will be conducted in primary care centers in Lleida

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: October 3, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: October 3, 2025

Record last verified: 2025-09