Personalized exercise prescription for adults 65 and older
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 project will try a personalized exercise prescription delivered in primary care to see if it helps sedentary adults aged 65 and older improve fitness, muscle strength, and quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 210 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Instituto de Investigación Biomédica de Salamanca Academic / other |
| Locations | 1 site (Villoría, Salamanca) |
| Trial ID | NCT07394790 on ClinicalTrials.gov |
What this trial studies
This randomized controlled study will enroll 210 adults aged 65 and older from a rural primary care center and perform baseline measures of strength, aerobic capacity, muscle mass, physical activity, and quality of life. After randomization, the intervention group receives a tailored exercise prescription generated through the MEDORA Primary Care electronic system and supervised by a qualified Exercise Technician, while the control group receives routine advice to walk briskly for at least 30 minutes daily. Participants are reassessed after three months with the same measures and outcomes include changes in physical fitness, activity level, muscle mass and function, and SF-36 quality of life, with subgroup analyses by sex and polypharmacy. Data are partially masked and managed in REDCap with anonymization.
Who should consider this trial
Good fit: Ideal candidates are adults aged 65 or older who are sedentary, motivated, clinically stable, able to consent, and can attend baseline and 3-month follow-up visits at the participating primary care center.
Not a fit: Patients with unstable cardiovascular or severe pulmonary conditions, acute illnesses that limit exercise, recent major cardiac events, or mental disorders preventing cooperation are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could increase physical activity and improve strength, mobility, and quality of life for older adults at risk of sarcopenia and reduced fitness.
How similar studies have performed: Prior research shows that tailored and supervised exercise programs generally improve strength, walking capacity, and quality of life in older adults, though primary care prescription programs have produced mixed results.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Villoría, Salamanca
- Centro de Salud de Villoria — Villoría, Salamanca, Spain (Recruiting)
Study contacts
- Study coordinator: Víctor Manuel González Rodríguez, MD
- Email: vmgonzalez@saludcastillayleon.es
- Phone: +34923 356 677
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.