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

Overview

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.

Interventions

• Behavioral 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 FI
• 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.

Primary outcome measures

• Change from Baseline in Clinical Frailty Scale (CFS) Score at 6 Months [Time frame: Baseline (Month 0) to Month 6]

Secondary outcome measures (12)

• Baseline (Month 0) to Month 6 [Time frame: Baseline (Month 0) to Month 6]
• Change from Baseline in Short Physical Performance Battery (SPPB) Score at 6 Months [Time frame: Baseline (Month 0) to Month 6]
• Change from Baseline in Gait Speed (4-Meter Walk Test) at 6 Months [Time frame: Baseline (Month 0) to Month 6]
• Change from Baseline in Timed Up and Go (TUG) Test Performance at 6 Months [Time frame: Baseline (Month 0) to Month 6]
• Change from Baseline in Estimated Skeletal Muscle Mass Index at 6 Months [Time frame: Baseline (Month 0) to Month 6]
• Change in Rectus Femoris and Vastus Lateralis Muscle Thickness at 6 Months [Time frame: Baseline (Month 0) to Month 6]
• Change from Baseline in Mini Nutritional Assessment-Short Form (MNA-SF) Score at 6 Months [Time frame: Baseline (Month 0) to Month 6]
• Change from Baseline in Mini-Mental State Examination (MMSE) Score at 6 Months [Time frame: Baseline (Month 0) to Month 6]
• Number of Participants with Hospital Admissions During the Study Period [Time frame: Baseline (Month 0) to Month 6]
• Number of Participants Reporting Falls During the Study Period [Time frame: Baseline (Month 0) to Month 6]
• Adherence to Home-Based Exercise Sessions (Self-Reported Completion Rate) [Time frame: Over the 12-week intervention]
• Self-Reported Enjoyment of Physical Activity (Likert Scale) at 6 Months [Time frame: At Month 6]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Crossover

Masking

Single blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07132632 · IDIAP-FRAIL65

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗