About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Recent myocardial infarction
Unstable angina
Uncontrolled arrhythmias (symptomatic or hemodynamically compromising)
Syncope
Trial design
Parallel
Treatments tested in this trial
Physical Exercise Prescription Program
BehavioralParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
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).
Secondary outcomes
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.
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.
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).
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.
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