Effect of a Multicomponent Therapeutic Exercise Program in Primary Care on Frailty and Sarcopenia in Older Adults (FRACTEP-65)

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Status: Not yet enrolling

Conditions: Aging; Exercises Therapy; Frailty; Sarcopenia

Treatments: Behavioral: 12-week multicomponent therapeutic exercise program including supervised and home-based sessions focused on strength, balance, mobility, and aerobic capacity; Behavioral: Placebo Pre-Treat

Study type: Interventional

Funder types: Other

Identifiers

NCT07132632

IDIAP-FRAIL65

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

60 participants in 2 patient groups, including a placebo group

Arm 1

Experimental group

Description:

Multicomponent Exercise Intervention

Treatment:

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

Control Arm

Placebo Comparator group

Treatment:

Behavioral: Placebo Pre-Treat