Chronic IllnessPRIMAPA-VARNCT05437978
"Sport on Prescription" in Primary Care for Patients With Long-term Illnesses
A study testing "Cap Sport Santé 83" program in people with Chronic Illness, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 1 site in France.
Trial summary
Adapted Physical Activity (APA) helps to prevent chronic diseases identified as major causes of mortality, particularly cardiovascular diseases and some cancers, according to the World Health Organization (WHO). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Illness
- What is being tested?
- "Cap Sport Santé 83" program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 siteFrance
- Study dates
- 19 Oct 2022to 6 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with a long-term illness of any type, or a chronic illness, or risk factors (such as hypertension or obesity), or persons with decreasing independance and a stabilised clinical condition
- Aged 18 years old or over
- Able to express his/her consent prior to participation in the study
- Understanding french language
- Affiliated to or beneficiary of a social security regimen
Who cannot join
- Patient with a contraindication to physical activity
- Pregnant women
- Patient under judicial protection (guardianship, curatorship...) or safeguard of justice
- Any other reason that, in the opinion of the investigator, might interfere with the evaluation of the study objectives
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Sport on Prescription" in Primary Care for Patients With Long-term Illnesses: From General Practitioners' Prescriptions to the "Maison Sport Santé" System for Adapted Physical Activity
Adapted Physical Activity (APA) helps to prevent chronic diseases identified as major causes of mortality, particularly cardiovascular diseases and some cancers, according to the World Health Organization (WHO). However, in general population, physical activity levels are below recommendations for nearly 40% of french adults. In France, general practitioners are now authorised and encouraged to prescribe APA to long-term illness patients.
In Var department in France, the " Maison Sport-Santé 83 " has set up a program called "Cap Sport Santé 83" to support patients who received a prescription to practice APA on a regular basis. This program helps long-term illness patients to restart physical activity by considering their pathology.
The aim of this study is to evaluate " Maison Sport-Santé 83 " APA program effectiveness using a rigorous scientific methodology.
- Conditions
- Chronic Illness
- Being tested
- "Cap Sport Santé 83" program
- Keywords
- Chronic disease, Adapted Physical Activity, Prescription, Quality of life
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Cap Sport Santé 83" programOther
In Var department (France), the " Maison Sport-Santé 83 " has set up a program called "Cap Sport Santé 83" to support patients who received a prescription to practice APA regularly. This program helps long-term illnesses patients to restart physical activity by considering their pathology. The "Cap Sport Santé 83" program is composed of 5 stages which aim to encourage adherence to APA practice by relying on the medical prescription system. Throughout the process, the patient is supervised and supported by the program's coordinator.
| Study group | Role | What they receive |
|---|---|---|
| Adapted Physical Activity (APA) program called "Cap Sport Santé 83" | Experimental | Not described Receives: Other: "Cap Sport Santé 83" program |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the program impact on quality of life by the physical component of SF-36 questionnaire
A high score corresponds to better health/quality of life.
Measured: 6 months
Secondary outcomes (13)
To evaluate the program impact on quality of life by the mental health and physical components of SF-36 questionnaire
A high score corresponds to better health/quality of life.
Measured: Up to 12 months
To evaluate physical activity by 6-minute walk test
The 6-minute walk test allows to classify patients according to their functional capacity degree (4 categories: no limitation, minimal limitation, moderate limitation, severe limitation) by measuring the distance covered by patients in 6 minutes.
Measured: Up to 12 months
To evaluate physical activity by 30-Second Sit to Stand Test
Patients will be asked to sit down and stand up without using arms, as many times as possible in 30 seconds. Number of completed repetitions will be recorded.
The more repetitions the patient does, the greater the muscle power of the lower limbs.
Measured: Up to 12 months
Physical activity and sedentary behaviour measured by the Global Physical Activity Questionnaire (GPAQ)
The GPAQ is an instrument to evaluate duration of vigorous and moderate physical activities covering 3 domains: activities at work, recreational domains and transport domains. Activity is calculated in MET value and classify patients according to 3 levels of physical activity defined as highly active, moderate and low.
Measured: Up to 12 months
Body composition measured by ultrasound and waist measurement.
Total mass, percentage of fat mass, percentage of lean mass will be measured by ultrasound and recorded as well as waist measurement.
Measured: Up to 12 months
Heart rate and heart rate variability measured with a heart rate monitor
Heart rate will be recorded
Measured: Up to 12 months
Quality of motivation to physical activity measured by the Motivation to Engage in Physical Activity in the Health Context Scale (EMAPS)
The EMAPS is a motivation scale toward health-oriented physical activity in French which includes 6 components of motivation underlined by self-determination theory. The higher the component scores, the higher the form of motivation associated with that component.
Measured: Up to 12 months
To measure Body Mass Index (BMI)
Weight and height will be recorded.
Measured: Up to 12 months
To measure Blood pressure by tensiometer
Blood pressure will be recorded.
Measured: Up to 12 months
Physical activity and sedentary behaviour measured by accelerometry
Accelerometry evaluate a subject's physical activity using sensors (accelerometers) that measure the body's accelerations and decelerations
Measured: Up to 6 months
Balance function
Patient's balance will be assessed thanks to an equilibrium test on one foot. Time before equilibrium loss will be measured by means of a chronometer.
Measured: Up to 12 months
Hand muscle strength
Hand muscle strength will be evaluated thank to a dynamometer which will have to be clutched as much as possible by the patient.
Measured: Up to 12 months
Trunk flexibility
Trunk flexibility will be assessed through a forward bend test. Once the patient has reached his maximal position, the distance between ground and his fingertips will be measured.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start19 Oct 2022
- Primary completion6 Feb 2025
- Study completion6 Feb 2025
Why it stopped: Too many missing data for primary outcome linked to patients stopping the program before the required visit
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic IllnessStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Marie LAMOULERE, MD, Study director, Maison Sport Santé 83
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05437978
- Sponsor's protocol ID
- 2022-CHITS-001
- Other IDs
- 2022-A00712-41
- Acronym
- PRIMAPA-VAR
- Status last verified
- Aug 2025
- First submitted
- 24 Jun 2022
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Sport on Prescription" in Primary Care for Patients With Long-term Illnesses: From General Practitioners' Prescriptions to the "Maison Sport Santé" System for Adapted Physical Activity
- ClinicalTrials.gov ID
- NCT05437978
- Acronym / sponsor ID
- PRIMAPA-VAR / 2022-CHITS-001
- Conditions
- Chronic Illness
- Keywords
- Chronic disease, Adapted Physical Activity, Prescription, Quality of life
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Too many missing data for primary outcome linked to patients stopping the program before the required visit
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur MerUniversity, hospital or other
- Study start
- 19 Oct 2022 (actual)
- Primary completion
- 6 Feb 2025 (actual)
- Study completion
- 6 Feb 2025 (actual)
- First posted
- 29 Jun 2022 (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.
Adapted Physical Activity (APA) helps to prevent chronic diseases identified as major causes of mortality, particularly cardiovascular diseases and some cancers, according to the World Health Organization (WHO). However, in general population, physical activity levels are below recommendations for nearly 40% of french adults. In France, general practitioners are now authorised and encouraged to prescribe APA to long-term illness patients.
In Var department in France, the " Maison Sport-Santé 83 " has set up a program called "Cap Sport Santé 83" to support patients who received a prescription to practice APA on a regular basis. This program helps long-term illness patients to restart physical activity by considering their pathology.
The aim of this study is to evaluate " Maison Sport-Santé 83 " APA program effectiveness using a rigorous scientific methodology.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adapted Physical Activity (APA) program called "Cap Sport Santé 83" | Experimental | Other: "Cap Sport Santé 83" program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient with a long-term illness of any type, or a chronic illness, or risk factors (such as hypertension or obesity), or persons with decreasing independance and a stabilised clinical condition
- Aged 18 years old or over
- Able to express his/her consent prior to participation in the study
- Understanding french language
- Affiliated to or beneficiary of a social security regimen
Key exclusion criteria (4 listed)
- Patient with a contraindication to physical activity
- Pregnant women
- Patient under judicial protection (guardianship, curatorship...) or safeguard of justice
- Any other reason that, in the opinion of the investigator, might interfere with the evaluation of the study objectives
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 |
|---|---|---|
| "Cap Sport Santé 83" programIn Var department (France), the " Maison Sport-Santé 83 " has set up a program called "Cap Sport Santé 83" to support patients who received a prescription to practice APA regularly. This program helps long-term illnesses patients to restart physical activity by considering their pathology. The "Cap Sport Santé 83" program is composed of 5 stages which aim to encourage adherence to APA practice by relying on the medical prescription system. Throughout the process, the patient is supervised and supported by the program's coordinator. | Other | Adapted Physical Activity (APA) program called "Cap Sport Santé 83" |
Primary outcome
To evaluate the program impact on quality of life by the physical component of SF-36 questionnaire
Time frame: 6 months
A high score corresponds to better health/quality of life.
13 secondary outcomes
To evaluate the program impact on quality of life by the mental health and physical components of SF-36 questionnaire
Time frame: Up to 12 months
To evaluate physical activity by 6-minute walk test
Time frame: Up to 12 months
To evaluate physical activity by 30-Second Sit to Stand Test
Time frame: Up to 12 months
Physical activity and sedentary behaviour measured by the Global Physical Activity Questionnaire (GPAQ)
Time frame: Up to 12 months
Body composition measured by ultrasound and waist measurement.
Time frame: Up to 12 months
Heart rate and heart rate variability measured with a heart rate monitor
Time frame: Up to 12 months
Quality of motivation to physical activity measured by the Motivation to Engage in Physical Activity in the Health Context Scale (EMAPS)
Time frame: Up to 12 months
To measure Body Mass Index (BMI)
Time frame: Up to 12 months
To measure Blood pressure by tensiometer
Time frame: Up to 12 months
Physical activity and sedentary behaviour measured by accelerometry
Time frame: Up to 6 months
Balance function
Time frame: Up to 12 months
Hand muscle strength
Time frame: Up to 12 months
Trunk flexibility
Time frame: Up to 12 months
Results and safety
The study was stopped early (reason given: Too many missing data for primary outcome linked to patients stopping the program before the required visit). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Jean-Marie LAMOULERE, MD study director
Maison Sport Santé 83
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Cap Sport Santé 83" program in people with Chronic Illness, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 1 site in France.
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 5 inclusion and 4 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: stopped early, as of the sponsor's last update on 7 Aug 2025. 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 France. 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?
The study was stopped early (reason given: Too many missing data for primary outcome linked to patients stopping the program before the required visit). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the program impact on quality of life by the physical component of SF-36 questionnaire (time frame: 6 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 7 Aug 2025.