"Sport on Prescription" in Primary Care for Patients With Long-term Illnesses

Chronic Illness Clinical Trial

— PRIMAPA-VAR  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05437978
• Other study ID #: 2022-CHITS-001
• Secondary ID: 2022-A00712-41
• Status: Recruiting
• Phase: N/A
• Start date: October 19, 2022
• Est. completion date: December 2026

Study information

• Verified date: March 2024
• Source: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
• Contact: Sophie Lafond
• Phone: 04 83 77 20 62
• Email: sophie.lafond[@]ch-toulon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 158
• Est. completion date: December 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Illness

Intervention

Other:
• "Cap Sport Santé 83" program
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.

Locations

Country	Name	City	State
France	Maison Sport Santé 83	Toulon	Var

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months
Secondary	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.	Up to 12 months
Secondary	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.	Up to 12 months
Secondary	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.	Up to 12 months
Secondary	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.	Up to 12 months
Secondary	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.	Up to 12 months
Secondary	Heart rate and heart rate variability measured with a heart rate monitor	Heart rate will be recorded	Up to 12 months
Secondary	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.	Up to 12 months
Secondary	To measure Body Mass Index (BMI)	Weight and height will be recorded.	Up to 12 months
Secondary	To measure Blood pressure by tensiometer	Blood pressure will be recorded.	Up to 12 months
Secondary	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	Up to 6 months
Secondary	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.	Up to 12 months
Secondary	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.	Up to 12 months
Secondary	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.	Up to 12 months