Sedentary LifestyleNCT07394790
Effectiveness of a Physical Exercise Prescription Program in Primary Care for Adults Aged 65 and Older: PREFIS-AP
A study testing Physical Exercise Prescription Program in people with Sedentary Lifestyle, run by Instituto de Investigación Biomédica de Salamanca at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sedentary Lifestyle
- What is being tested?
- Physical Exercise Prescription Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteSpain
- Study dates
- 9 Feb 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- Recent myocardial infarction
- Unstable angina
- Uncontrolled arrhythmias (symptomatic or hemodynamically compromising)
- Syncope
- Acute endocarditis, myocarditis, or pericarditis
- Severe or symptomatic aortic stenosis
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Víctor Manuel González Rodríguez, MD contact
Spain1 site, 1 recruiting
- Recruiting
Centro de Salud de Villoria
Villoría, Salamanca, 37339
Víctor Manuel González Rodríguez, MD, 34 923 356 677 ext. 54196, vmgonzalez@saludcastillayleon.es
About this study
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
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.
Read the 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.
- Conditions
- Sedentary Lifestyle
- Being tested
- Physical Exercise Prescription Program
- Keywords
- aging, sarcopenia, Reduced physical fitness
- Medical subject headings
- Sedentary Behavior, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Exercise Prescription ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Physical Exercise Prescription Program | Experimental | Participants undergo a structured, individualized 12-week Physical Exercise Prescription Program developed after a comprehensive baseline assessment of physical fitness, muscle strength, muscle mass, and physical activity levels. The prescription is generated through the MEDORA Primary Care electronic system and includes five exercise components. Receives: Behavioral: Physical Exercise Prescription Program |
| Standard Health Advice | No intervention | Participants receive general advice to engage in brisk walking on flat terrain for at least 30 minutes daily, consistent with typical Primary Care counseling. No structured exercise plan is provided. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline to 3 months.
Secondary outcomes (11)
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.
Measured: Baseline to 3 months.
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.
Measured: Baseline to 3 months.
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).
Measured: Baseline to 3 months.
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.
Measured: Baseline to 3 months.
Muscle Mass - Calf Circumference
Change in muscle mass estimated by calf circumference (cm), measured at the widest point of the calf using a flexible tape. A value <31 cm will be considered indicative of potential muscle mass deficit.
Measured: Baseline to 3 months.
Muscle Mass - Ultrasound of Rectus Femoris
Change in quantitative and qualitative muscle parameters assessed by ultrasound of the rectus femoris (muscle thickness, cross-sectional area, and echogenicity), following validated measurement criteria for sarcopenia assessment.
Measured: Baseline to 3 months.
Sex Differences in Response to the Exercise Prescription Program (Standardized Change Score)
This outcome will assess whether biological sex modifies the effect of the intervention on functional and health-related outcomes. Sex-specific differences will be evaluated using standardized change scores (z-scores).
The standardized composite score will be derived from the following previously defined outcome measures:
Muscle strength (handgrip dynamometry (kg) and the 30-second chair stand test) Aerobic capacity (6-minute walk test) Muscle mass, assessed by calf circumference (cm) and ultrasound measurements of rectus femoris muscle thickness Physical activity level, (Global Physical Activity Questionnaire (GPAQ) Health-related quality of life (SF-36 questionnaire) Each variable will be standardized before aggregation to ensure comparability across different units of measurement. The resulting composite score will be compared between men and women to determine if sex influences the magnitude of response to the exercise prescription program.
Measured: Baseline to 3 months.
Correlation Between Polypharmacy and Change in Handgrip Strength
This outcome will assess the correlation between baseline medication burden and change in muscle strength in older adults from baseline to 3 months.
Medication burden will be defined as the total number of chronic medications taken at baseline (unit: number of medications).
Muscle strength will be assessed by handgrip strength, measured in kilograms (kg) using a calibrated hand dynamometer. Change in handgrip strength will be calculated as the difference between baseline and 3-month values.
Measured: Baseline to 3 months
Correlation Between Polypharmacy and Change in Appendicular Skeletal Muscle Mass
This outcome will assess the correlation between baseline medication burden and change in muscle mass in older adults from baseline to 3 months.
Medication burden will be defined as the total number of chronic medications taken at baseline (unit: number of medications).
Muscle mass will be assessed as appendicular skeletal muscle mass, measured in kilograms (kg) using dual-energy X-ray absorptiometry (DXA). Change in muscle mass will be calculated as the difference between baseline and 3-month values.
Measured: Baseline to 3 months
Correlation Between Polypharmacy and Change in Physical Performance
This outcome will assess the correlation between baseline medication burden and change in physical performance in older adults from baseline to 3 months.
Medication burden will be defined as the total number of chronic medications taken at baseline (unit: number of medications).
Physical performance will be assessed using the Short Physical Performance Battery (SPPB), reported as a total score (points on a standardized scale). Change in SPPB score will be calculated as the difference between baseline and 3-month values.
Measured: Baseline to 3 months
Correlation Between Polypharmacy and Change in Quality of Life
This outcome will assess the correlation between baseline medication burden and change in quality of life in older adults from baseline to 3 months.
Medication burden will be defined as the total number of chronic medications taken at baseline (unit: number of medications).
Quality of life will be assessed using the EuroQol-5 Dimension (EQ-5D) questionnaire, reported as a standardized index score. Change in EQ-5D score will be calculated as the difference between baseline and 3-month values.
Measured: Baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start9 Feb 2026
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary LifestyleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned (1:1) to either an individualized exercise prescription program or standard lifestyle advice. Assessors and data analysts will remain blinded to group allocation.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Biomédica de Salamanca
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07394790
- Sponsor's protocol ID
- PREFIS-AP
- Status last verified
- Apr 2026
- First submitted
- 12 Dec 2025
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized datasets and analytic code will be available upon reasonable request, following approval by the Ethics Committee and IBSAL data governance board.
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07394790
- Acronym / sponsor ID
- PREFIS-AP
- Conditions
- Sedentary Lifestyle
- Keywords
- aging, sarcopenia, Reduced physical fitness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Instituto de Investigación Biomédica de SalamancaUniversity, hospital or other
- Study start
- 9 Feb 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 6 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned (1:1) to either an individualized exercise prescription program or standard lifestyle advice. Assessors and data analysts will remain blinded to group allocation.
| Arm | Type | Receives |
|---|---|---|
| Physical Exercise Prescription Program | Experimental | Behavioral: Physical Exercise Prescription ProgramParticipants undergo a structured, individualized 12-week Physical Exercise Prescription Program developed after a comprehensive baseline assessment of physical fitness, muscle strength, muscle mass, and physical activity levels. The prescription is generated through the MEDORA Primary Care electronic system and includes five exercise components. |
| Standard Health Advice | No intervention | –Participants receive general advice to engage in brisk walking on flat terrain for at least 30 minutes daily, consistent with typical Primary Care counseling. No structured exercise plan is provided. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- Recent myocardial infarction
- Unstable angina
- Uncontrolled arrhythmias (symptomatic or hemodynamically compromising)
- Syncope
- Acute endocarditis, myocarditis, or pericarditis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical Exercise Prescription ProgramParticipants 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. | Behavioural | Physical Exercise Prescription Program |
Primary outcome
Change in Quality of Life
Time frame: Baseline to 3 months.
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).
11 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: Yes. Anonymized datasets and analytic code will be available upon reasonable request, following approval by the Ethics Committee and IBSAL data governance board.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Víctor Manuel González Rodríguez, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Exercise Prescription Program in people with Sedentary Lifestyle, run by Instituto de Investigación Biomédica de Salamanca at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Víctor Manuel González Rodríguez, MD (+34923 356 677 ext. 54196, vmgonzalez@saludcastillayleon.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quality of Life (time frame: Baseline to 3 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.