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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorInstituto de Investigación Biomédica de Salamanca

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Physical Exercise Prescription Program

    Behavioral

    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.

Treatment groups

210 Participants
are divided into 2 treatment groups
Group A: Physical Exercise Prescription ProgramExperimental treatment 1 intervention
Group B: Standard Health AdviceNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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).

Time frame
Baseline to 3 months.

Secondary outcomes

1

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.

Time frame
Baseline to 3 months.
2

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.

Time frame
Baseline to 3 months.
3

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).

Time frame
Baseline to 3 months.
4

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.

Time frame
Baseline to 3 months.

Other outcomes

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