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

Effectiveness of a Physical Exercise Prescription Program in Primary Care to Improve Physical Fitness and Quality of Life in Adults Aged 65 Years and Older in a Rural Health Area: PREFIS-AP Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Sedentary Lifestyle
• Intervention / Treatment: Behavioral: Physical Exercise Prescription Program

Detailed Description

Sedentary behavior is strongly associated with multiple adverse health outcomes, particularly in older adults. Conventional lifestyle advice alone has shown limited effectiveness in increasing physical activity levels. Exercise prescription delivered through structured evaluation, individualized planning, and scheduled follow-up may lead to clinically significant improvements in physical function and quality of life.

This study will recruit 210 adults aged ≥65 years from a rural Primary Care center. Participants will undergo baseline assessments including sociodemographic variables, anthropometric measures, muscle strength (handgrip dynamometry and chair stand test), aerobic capacity (6-minute walk test), muscle mass (calf circumference and ultrasound of rectus femoris), physical activity level (GPAQ), and quality of life (SF-36). After randomization (1:1), the intervention group will receive a personalized exercise prescription generated through the MEDORA Primary Care electronic system and supervised by a qualified Exercise Technician. The control group will receive routine health advice.

After three months, all participants will be reassessed using the same measures. The study will analyze the effect of the intervention on physical fitness, physical activity, muscle mass and function, and quality of life, including sex-specific differences and the role of polypharmacy. The project incorporates a partial masking strategy and uses REDCap for data management and anonymization.

• Study Type: Interventional
• Enrollment (Estimated): 210
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Víctor Manuel González Rodríguez, MD; Phone Number: 54196 +34923 356 677; Email: vmgonzalez@saludcastillayleon.es

Study Locations

• Spain
  • Salamanca
    • Villoría, Salamanca, Spain, 37339
      • Recruiting
      • Centro de Salud de Villoria
      • Contact: Víctor Manuel González Rodríguez, MD; Phone Number: 54196 34 923 356 677; Email: vmgonzalez@saludcastillayleon.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Physical Exercise Prescription Program; 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; 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.
No Intervention: Standard Health Advice; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Activity Level (GPAQ)	Change in physical activity level as measured by the Global Physical Activity Questionnaire (GPAQ), including time spent in work-related activity, transport-related activity, leisure-time activity, and sedentary behavior. Participants will be classified into WHO categories (high, moderate, or low/inactive) based on standardized scoring procedures.	Baseline to 3 months.
Aerobic Capacity (6-Minute Walk Test)	Change in functional aerobic capacity assessed by the 6-minute walk test (6MWT). The primary variable will be the total distance walked in meters during 6 minutes. Physiological responses (heart rate, oxygen saturation, perceived exertion using Borg scale) will also be recorded.	Baseline to 3 months.
Muscle Strength - Handgrip Dynamometry	Change in maximal isometric handgrip strength measured with a JAMAR dynamometer (kg), using the highest value from standardized bilateral measurements. Cut-off values will follow European sarcopenia consensus criteria (<27 kg for men; <16 kg for women).	Baseline to 3 months.
Muscle Strength - Chair Stand Test	Change in lower-limb functional strength measured by the 30-second chair stand test. The outcome is the total number of complete sit-to-stand repetitions performed within 30 seconds following standardized protocol.	Baseline to 3 months.
Muscle Mass - Calf Circumference	Change in muscle mass estimated by calf circumference (cm), measured at the widest point of the calf using a flexible tape. A value <31 cm will be considered indicative of potential muscle mass deficit.	Baseline to 3 months.
Muscle Mass - Ultrasound of Rectus Femoris	Change in quantitative and qualitative muscle parameters assessed by ultrasound of the rectus femoris (muscle thickness, cross-sectional area, and echogenicity), following validated measurement criteria for sarcopenia assessment.	Baseline to 3 months.
Sex Differences in Response to the Exercise Prescription Program (Standardized Change Score)	This outcome will assess whether biological sex modifies the effect of the intervention on functional and health-related outcomes. Sex-specific differences will be evaluated using standardized change scores (z-scores). The standardized composite score will be derived from the following previously defined outcome measures: Muscle strength (handgrip dynamometry (kg) and the 30-second chair stand test) Aerobic capacity (6-minute walk test) Muscle mass, assessed by calf circumference (cm) and ultrasound measurements of rectus femoris muscle thickness Physical activity level, (Global Physical Activity Questionnaire (GPAQ) Health-related quality of life (SF-36 questionnaire) Each variable will be standardized before aggregation to ensure comparability across different units of measurement. The resulting composite score will be compared between men and women to determine if sex influences the magnitude of response to the exercise prescription program.	Baseline to 3 months.
Correlation Between Polypharmacy and Change in Handgrip Strength	This outcome will assess the correlation between baseline medication burden and change in muscle strength in older adults from baseline to 3 months. Medication burden will be defined as the total number of chronic medications taken at baseline (unit: number of medications). Muscle strength will be assessed by handgrip strength, measured in kilograms (kg) using a calibrated hand dynamometer. Change in handgrip strength will be calculated as the difference between baseline and 3-month values.	Baseline to 3 months
Correlation Between Polypharmacy and Change in Appendicular Skeletal Muscle Mass	This outcome will assess the correlation between baseline medication burden and change in muscle mass in older adults from baseline to 3 months. Medication burden will be defined as the total number of chronic medications taken at baseline (unit: number of medications). Muscle mass will be assessed as appendicular skeletal muscle mass, measured in kilograms (kg) using dual-energy X-ray absorptiometry (DXA). Change in muscle mass will be calculated as the difference between baseline and 3-month values.	Baseline to 3 months
Correlation Between Polypharmacy and Change in Physical Performance	This outcome will assess the correlation between baseline medication burden and change in physical performance in older adults from baseline to 3 months. Medication burden will be defined as the total number of chronic medications taken at baseline (unit: number of medications). Physical performance will be assessed using the Short Physical Performance Battery (SPPB), reported as a total score (points on a standardized scale). Change in SPPB score will be calculated as the difference between baseline and 3-month values.	Baseline to 3 months
Correlation Between Polypharmacy and Change in Quality of Life	This outcome will assess the correlation between baseline medication burden and change in quality of life in older adults from baseline to 3 months. Medication burden will be defined as the total number of chronic medications taken at baseline (unit: number of medications). Quality of life will be assessed using the EuroQol-5 Dimension (EQ-5D) questionnaire, reported as a standardized index score. Change in EQ-5D score will be calculated as the difference between baseline and 3-month values.	Baseline to 3 months

Collaborators and Investigators

• Sponsor: Instituto de Investigación Biomédica de Salamanca

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 12, 2025
• First Submitted That Met QC Criteria: February 5, 2026
• First Posted (Actual): February 6, 2026

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: aging; sarcopenia; Reduced physical fitness
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Sarcopenia; Sedentary Behavior
• Other Study ID Numbers: PREFIS-AP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized datasets and analytic code will be available upon reasonable request, following approval by the Ethics Committee and IBSAL data governance board.
• IPD Sharing Time Frame: Data will be available starting 12 months after publication of primary results and for a minimum of 5 years thereafter.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No