Actively Recruiting

Phase Not Applicable
Age: 65Years +
All Genders
Healthy Volunteers
ID07394790

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

Led by Instituto de Investigación Biomédica de Salamanca · Updated on 2026-04-27

210

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a Physical Exercise Prescription Program designed for adults aged 65 years and older who lead a sedentary lifestyle. This randomized controlled trial aims to compare the effects of an individualized exercise plan against standard health advice to walk briskly for at least 30 minutes daily. The study also investigates how polypharmacy relates to muscle function, physical performance, and quality of life in this population. The intervention group participates in a structured 12-week exercise program tailored through a detailed baseline assessment of physical fitness, muscle strength, muscle mass, and physical activity levels. This plan includes aerobic exercise, strength training with elastic bands, respiratory exercises using pressure-based devices, flexibility routines, and balance training. A certified Exercise Technician supervises and adjusts the program. The control group receives routine advice to walk briskly daily without a structured plan. Participants will undergo assessments at the start and after three months, including measurements of muscle strength, aerobic capacity, muscle mass, physical activity level, and quality of life using validated tests and questionnaires. Data will be managed anonymously, and the effects of the intervention on physical fitness and quality of life, including sex-specific differences, will be analyzed. Total participation spans the 12-week intervention with follow-up evaluation at three months.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 65Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 65 years or older
  • Motivated to participate and able to provide informed consent
  • Able to attend baseline assessment and follow-up visits
  • Clinically stable and able to participate in exercise evaluation
Not Eligible

You will not qualify if you...

  • 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 impairing exercise capacity (e.g., infection, thyrotoxicosis, acute renal failure)
  • Mental disorder preventing adequate cooperation

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 12 weeks

Participants either follow a personalized 12-week physical exercise program supervised by an Exercise Technician or receive general health advice for physical activity.

1 baseline visit and 1 follow-up visit after 3 months

Trial Site Locations

Total: 1 location

1

Centro de Salud de Villoria

Villoría, Salamanca, Spain, 37339

Actively Recruiting

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Research Team

V

Víctor Manuel González Rodríguez, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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