Effectiveness of a Physical Exercise Prescription Program in Primary Care for Adults Aged 65 and Older: PREFIS-AP

NCT07394790 | Recruiting

• 1 other identifier: PREFIS-AP
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial aims to evaluate the effectiveness of an individualized Physical Exercise Prescription Program delivered in Primary Care for adults aged 65 years and older. The intervention includes a structured assessment of physical fitness, muscle function and mass, physical activity level, and quality of life, followed by a tailored exercise plan encompassing aerobic, strength, respiratory, flexibility, and balance training. Outcomes will be compared with a control group receiving standard health advice to walk briskly for at least 30 minutes daily. The study also explores associations between polypharmacy, muscle function, physical performance, and quality of life.

Conditions

Sedentary Lifestyle

Keywords

aging; sarcopenia; Reduced physical fitness

Outcome Measures

Primary Outcomes (1)

• Change in Quality of Life

  Quality of Life will be measured by the SF-36 questionnaire. The SF-36 questionnaire is a widely used, patient-reported questionnaire measuring health-related quality of life. It uses points to assess health, with responses on Likert scales (e.g., 0 to 100) transformed into scores for 8 health domains: physical functioning, role limitations (physical/emotional), bodily pain, general health, vitality, social functioning, and mental health, where higher scores mean better health, ranging from 0 (maximum disability) to 100 (no disability).

  Baseline to 3 months.

Secondary Outcomes (11)

• Physical Activity Level (GPAQ)

  Baseline to 3 months.

• Aerobic Capacity (6-Minute Walk Test)

  Baseline to 3 months.

• Muscle Strength - Handgrip Dynamometry

  Baseline to 3 months.

• Muscle Strength - Chair Stand Test

  Baseline to 3 months.

• Muscle Mass - Calf Circumference

  Baseline to 3 months.

Study Arms (2)

Physical Exercise Prescription Program

EXPERIMENTAL

Participants undergo a structured, individualized 12-week Physical Exercise Prescription Program developed after a comprehensive baseline assessment of physical fitness, muscle strength, muscle mass, and physical activity levels. The prescription is generated through the MEDORA Primary Care electronic system and includes five exercise components.

Behavioral: Physical Exercise Prescription Program

Standard Health Advice

NO INTERVENTION

Participants receive general advice to engage in brisk walking on flat terrain for at least 30 minutes daily, consistent with typical Primary Care counseling. No structured exercise plan is provided.

Interventions

Physical Exercise Prescription Program BEHAVIORAL

Participants receive a structured and individualized 12-week program including: Aerobic exercise (continuous and interval training, intensity guided by Borg scale) Strength training using elastic bands (progressively increasing repetitions, series, and load) Respiratory exercises with pressure-based devices Flexibility exercises (static stretching routines) Balance training (single-leg stance, heel-toe walking, eyes-closed tasks) The program is generated through the MEDORA electronic system after baseline evaluation. A certified Exercise Technician provides instruction, supervision, and progression adjustments.

Physical Exercise Prescription Program

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥ 65 years
• Motivated to participate and able to provide informed consent
• Able to attend baseline assessment and follow-up
• Clinical stability allowing participation in exercise evaluation

You may not qualify if:

• Recent myocardial infarction
• Unstable angina
• Uncontrolled arrhythmias (symptomatic or hemodynamically compromising)
• Syncope
• Acute endocarditis, myocarditis, or pericarditis
• Severe or symptomatic aortic stenosis
• Uncontrolled heart failure
• Recent pulmonary thromboembolism or pulmonary infarction
• Lower-limb thrombosis
• Severe aortic stenosis or suspected dissecting aortic aneurysm
• Uncontrolled asthma
• Pulmonary edema
• Acute respiratory failure
• Acute non-cardiopulmonary illness that impairs exercise capacity (e.g., infection, thyrotoxicosis, acute renal failure)
• Mental disorder that prevents adequate cooperation.

Sponsors & Collaborators

• Instituto de Investigación Biomédica de Salamanca: lead

Study Sites (1)

Centro de Salud de Villoria

Villoría, Salamanca, 37339, Spain

RECRUITING

MeSH Terms

Conditions

Sedentary Behavior; Sarcopenia

Condition Hierarchy (Ancestors)

Behavior; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Central Study Contacts

Víctor Manuel González Rodríguez, MD

CONTACT

+34923 356 677; vmgonzalez@saludcastillayleon.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned (1:1) to either an individualized exercise prescription program or standard lifestyle advice. Assessors and data analysts will remain blinded to group allocation.

Study Record Dates

• First Submitted: December 12, 2025
• First Posted: February 6, 2026
• Study Start: February 9, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Data will be available starting 12 months after publication of primary results and for a minimum of 5 years thereafter.
• Access Criteria: Qualified researchers with a methodologically sound proposal, as determined by the study steering committee, will be able to access the data. Requests should be directed to the study PI. A data access agreement will be required.

Locations

ES (1)