- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05437978
"Sport on Prescription" in Primary Care for Patients With Long-term Illnesses (PRIMAPA-VAR)
"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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Var
-
Toulon, Var, France, 83000
- Maison Sport Santé 83
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Adapted Physical Activity (APA) program called "Cap Sport Santé 83"
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To evaluate physical activity by 6-minute walk test
Time Frame: Up to 12 months
|
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.
|
Up to 12 months
|
|
To evaluate physical activity by 30-Second Sit to Stand Test
Time Frame: Up to 12 months
|
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. |
Up to 12 months
|
|
Physical activity and sedentary behaviour measured by the Global Physical Activity Questionnaire (GPAQ)
Time Frame: Up to 12 months
|
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.
|
Up to 12 months
|
|
Body composition measured by ultrasound and waist measurement.
Time Frame: Up to 12 months
|
Total mass, percentage of fat mass, percentage of lean mass will be measured by ultrasound and recorded as well as waist measurement.
|
Up to 12 months
|
|
Heart rate and heart rate variability measured with a heart rate monitor
Time Frame: Up to 12 months
|
Heart rate will be recorded
|
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
|
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.
|
Up to 12 months
|
|
To measure Body Mass Index (BMI)
Time Frame: Up to 12 months
|
Weight and height will be recorded.
|
Up to 12 months
|
|
To measure Blood pressure by tensiometer
Time Frame: Up to 12 months
|
Blood pressure will be recorded.
|
Up to 12 months
|
|
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
|
A high score corresponds to better health/quality of life.
|
Up to 12 months
|
|
Physical activity and sedentary behaviour measured by accelerometry
Time Frame: Up to 6 months
|
Accelerometry evaluate a subject's physical activity using sensors (accelerometers) that measure the body's accelerations and decelerations
|
Up to 6 months
|
|
Balance function
Time Frame: Up to 12 months
|
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.
|
Up to 12 months
|
|
Hand muscle strength
Time Frame: Up to 12 months
|
Hand muscle strength will be evaluated thank to a dynamometer which will have to be clutched as much as possible by the patient.
|
Up to 12 months
|
|
Trunk flexibility
Time Frame: Up to 12 months
|
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.
|
Up to 12 months
|
Collaborators and Investigators
Investigators
- Study Director: Jean-Marie LAMOULERE, MD, Maison Sport Santé 83
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-CHITS-001
- 2022-A00712-41 (Other Identifier: ID-RCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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