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

Official title

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

Overview

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.

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.

Interventions

• 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 syste

Primary outcome measures

• Change in Quality of Life [Time frame: Baseline to 3 months.]

Secondary outcome measures (11)

• Physical Activity Level (GPAQ) [Time frame: Baseline to 3 months.]
• Aerobic Capacity (6-Minute Walk Test) [Time frame: Baseline to 3 months.]
• Muscle Strength - Handgrip Dynamometry [Time frame: Baseline to 3 months.]
• Muscle Strength - Chair Stand Test [Time frame: Baseline to 3 months.]
• Muscle Mass - Calf Circumference [Time frame: Baseline to 3 months.]
• Muscle Mass - Ultrasound of Rectus Femoris [Time frame: Baseline to 3 months.]
• Sex Differences in Response to the Exercise Prescription Program (Standardized Change Score) [Time frame: Baseline to 3 months.]
• Correlation Between Polypharmacy and Change in Handgrip Strength [Time frame: Baseline to 3 months]
• Correlation Between Polypharmacy and Change in Appendicular Skeletal Muscle Mass [Time frame: Baseline to 3 months]
• Correlation Between Polypharmacy and Change in Physical Performance [Time frame: Baseline to 3 months]
• Correlation Between Polypharmacy and Change in Quality of Life [Time frame: Baseline to 3 months]

Eligibility criteria

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.

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

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

Spain · 1 center

• Centro de Salud de Villoria — Villoría

Identifiers

NCT: NCT07394790 · PREFIS-AP

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗