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NCT Number: NCT07132632

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

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.

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Key information

Conditions

Frailty Aging Atrophy Exercises Therapy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

Placebo Pre-Treat

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.

Primary outcomes

  1. Change from Baseline in Clinical Frailty Scale (CFS) Score at 6 Months

    Time frame: Baseline (Month 0) to Month 6

    Clinical Frailty Scale (CFS) is a 9-point ordinal scale assessing functional and clinical status in older adults. A change of ≥0.5 points is considered clinically significant.

Secondary outcomes

  1. Baseline (Month 0) to Month 6

    Time frame: Baseline (Month 0) to Month 6

    Handgrip strength measured using a Jamar® dynamometer. The average of three trials per hand will be used. A decrease indicates lower muscle strength, a key sarcopenia marker.

  2. Change from Baseline in Short Physical Performance Battery (SPPB) Score at 6 Months

    Time frame: Baseline (Month 0) to Month 6

    Composite score from balance tests, 4-meter gait speed, and chair rise test. Score ranges from 0 to 12, with ≤8 indicating poor physical performance.

  3. Change from Baseline in Gait Speed (4-Meter Walk Test) at 6 Months

    Time frame: Baseline (Month 0) to Month 6

    Average walking speed over 4 meters. Lower speeds (<0.8 m/s) are associated with higher frailty and fall risk.

  4. Change from Baseline in Timed Up and Go (TUG) Test Performance at 6 Months

    Time frame: Baseline (Month 0) to Month 6

    Time to rise from a chair, walk 3 meters, turn, return, and sit. Times ≥13.5 seconds indicate increased fall risk.

  5. Change from Baseline in Estimated Skeletal Muscle Mass Index at 6 Months

    Time frame: Baseline (Month 0) to Month 6

    Calculated using anthropometric data via Lee et al.'s validated formula.

  6. Change in Rectus Femoris and Vastus Lateralis Muscle Thickness at 6 Months

    Time frame: Baseline (Month 0) to Month 6

    Ultrasound-based assessment of muscle thickness and adipose tissue content in the dominant lower limb.

  7. Change from Baseline in Mini Nutritional Assessment-Short Form (MNA-SF) Score at 6 Months

    Time frame: Baseline (Month 0) to Month 6

    Nutrition screening tool (score 0-14). Categories: well-nourished (>11), at risk (8-11), malnourished (<8).

  8. Change from Baseline in Mini-Mental State Examination (MMSE) Score at 6 Months

    Time frame: Baseline (Month 0) to Month 6

    Cognitive status measured with MMSE (score 0-30). Scores <26 suggest cognitive impairment.

  9. Number of Participants with Hospital Admissions During the Study Period

    Time frame: Baseline (Month 0) to Month 6

    Self-reported or caregiver-reported data on hospitalizations.

  10. Number of Participants Reporting Falls During the Study Period

    Time frame: Baseline (Month 0) to Month 6

    Number of self-reported falls tracked throughout the study.

  11. Adherence to Home-Based Exercise Sessions (Self-Reported Completion Rate)

    Time frame: Over the 12-week intervention

    Percentage of home-based sessions completed, based on self-records and phone follow-up.

  12. Self-Reported Enjoyment of Physical Activity (Likert Scale) at 6 Months

    Time frame: At Month 6

    Degree of enjoyment assessed on a Likert scale from 1 (not enjoyable) to 5 (very enjoyable).

Sponsors and collaborators

Lead sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Other

Registry information

Acronym: FRACTEP-65

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 20, 2025
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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