Effect of a Multicomponent Therapeutic Exercise Program in Primary Care on Frailty and Sarcopenia in Older Adults

NCT ID: NCT07132632

Last Updated: 2025-08-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-02
• Study Completion Date: 2026-12-31

Brief Summary

Background:

Frailty and sarcopenia are common conditions in older adults that increase the risk of disability, dependence, and hospitalizations. Frailty is characterized by decreased physiological reserve and functional capacity, while sarcopenia refers to the loss of muscle mass, strength, and performance. Both conditions are prevalent among older adults and represent a growing public health challenge as the population ages.

Objective:

This study aims to evaluate the effectiveness of a multicomponent therapeutic exercise program in reducing frailty and improving clinical parameters related to sarcopenia in community-dwelling older adults aged 65 years or older who attend primary care centers.

Study Design:

This is a quasi-experimental, multicenter, single-group pre-post clinical trial. The study includes two phases: a control phase (pre-intervention observation) and an experimental phase (intervention). Each participant will act as their own control.

Participants:

60 older adults aged 65 or older will be recruited from primary care centers in the Baix Llobregat region (Catalonia, Spain). Eligibility criteria include mild to moderate frailty (Clinical Frailty Scale 4-6), ability to walk independently (with or without a walking aid), cognitive ability to follow instructions (MMSE ≥ 20), and clinical stability. Exclusion criteria include severe frailty, major cognitive impairment, acute illness, or participation in another structured exercise program.

Intervention:

Participants will take part in a 12-week multicomponent exercise program including 8 supervised sessions at the primary care center and 4 home-based sessions. Each session will last 60 minutes and include strength training, balance exercises, aerobic activity, and flexibility. The program follows FITT-VP principles (frequency, intensity, time, type, volume, and progression). Home sessions will be supported with illustrated manuals and biweekly follow-up calls.

Outcomes:

The primary outcome is the change in frailty level measured by the Clinical Frailty Scale (CFS). Secondary outcomes include handgrip strength, SARC-F score, Short Physical Performance Battery (SPPB), 4-meter walk test, Timed Up and Go (TUG), muscle mass index, rectus femoris and vastus lateralis ultrasound, cognitive status (MMSE), nutritional status (MNA-SF), falls, and hospitalizations. Assessments will be conducted at baseline (month 0), after the control phase (month 3), and after the intervention (month 6).

Significance:

This study will provide evidence on the medium-term effectiveness of a short, structured, and feasible intervention implemented in real-life primary care settings. If effective, this program could be integrated into preventive strategies to reduce frailty and sarcopenia, promote autonomy, and improve the quality of life among older adults. Results will inform clinical guidelines and contribute to the development of scalable interventions for aging populations.

Conditions

Frailty; Sarcopenia; Aging; Exercises Therapy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Arm 1

Multicomponent Exercise Intervention

Group Type: EXPERIMENTAL

12-week multicomponent therapeutic exercise program including supervised and home-based sessions focused on strength, balance, mobility, and aerobic capacity

Intervention Type: BEHAVIORAL

This intervention consists of a 12-week multicomponent therapeutic exercise program for older adults with mild to moderate frailty. Participants will complete 12 sessions (8 supervised in primary care and 4 home-based), each lasting approximately 60 minutes. Sessions include warm-up, strength exercises (using body weight or elastic bands), moderate aerobic activity (e.g., walking or pedaling), balance and coordination training (including dual tasks), and a cool-down phase. The program follows FITT-VP principles and is tailored to functional capacity. Intensity is monitored using the Borg scale (CR10 and RPE), estimated 1RM (20-80%), and 64-76% HRmax. Exercises are progressively adjusted in volume, intensity, and complexity. Home sessions are guided by an illustrated manual and reinforced by biweekly follow-up phone calls to promote adherence and safety. The intervention is aligned with international guidelines and aims to improve physical performance, reduce frailty and sarcopenia.

Control Arm

Group Type: PLACEBO_COMPARATOR

Placebo Pre-Treat

Intervention Type: BEHAVIORAL

The pre-intervention period (Month 0 to Month 3) will serve as the control phase, during which participants will receive no specific exercise program. From Month 3 to Month 6, the intervention phase will begin. Participants act as their own control.

Interventions

12-week multicomponent therapeutic exercise program including supervised and home-based sessions focused on strength, balance, mobility, and aerobic capacity

This intervention consists of a 12-week multicomponent therapeutic exercise program for older adults with mild to moderate frailty. Participants will complete 12 sessions (8 supervised in primary care and 4 home-based), each lasting approximately 60 minutes. Sessions include warm-up, strength exercises (using body weight or elastic bands), moderate aerobic activity (e.g., walking or pedaling), balance and coordination training (including dual tasks), and a cool-down phase. The program follows FITT-VP principles and is tailored to functional capacity. Intensity is monitored using the Borg scale (CR10 and RPE), estimated 1RM (20-80%), and 64-76% HRmax. Exercises are progressively adjusted in volume, intensity, and complexity. Home sessions are guided by an illustrated manual and reinforced by biweekly follow-up phone calls to promote adherence and safety. The intervention is aligned with international guidelines and aims to improve physical performance, reduce frailty and sarcopenia.

Intervention Type: BEHAVIORAL

Placebo Pre-Treat

The pre-intervention period (Month 0 to Month 3) will serve as the control phase, during which participants will receive no specific exercise program. From Month 3 to Month 6, the intervention phase will begin. Participants act as their own control.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Adults aged 65 years or older, receiving care from primary care physiotherapists at participating health centers.
• Clinical Frailty Scale (CFS) score between 4 and 6 (indicating vulnerable, mild, or moderate frailty).
• Ability to walk independently, with or without assistive devices (excluding habitual wheelchair use).
• Clinically stable, defined as the absence of acute events or clinical decompensation in the previous 4 weeks.
• Sufficient cognitive ability to understand and follow basic instructions, or the availability of an actively involved caregiver (MMSE ≥ 20 or equivalent).
• Signed informed consent from the participant or their legal representative.

Exclusion Criteria

• Diagnosis of severe frailty or advanced dependence (CFS ≥ 7).
• Severe neurological or musculoskeletal disorders that limit safe exercise participation (e.g., Parkinson's disease, stroke with major sequelae, disabling arthropathies).
• Uncontrolled cardiac, respiratory, or other medical conditions that contraindicate physical activity.
• Moderate to severe cognitive impairment, defined by MMSE < 20 or a clinical diagnosis of dementia with significant functional limitations.
• Simultaneous participation in other structured physical intervention programs.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

OTHER

Sponsor Role: lead

Responsible Party

Yaiza Casas

Principal Investigator and Physiotherapist, Primary Care - Institut Català de la Salut (ICS)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

IDIAP-FRAIL65

Identifier Type: -

Identifier Source: org_study_id