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"Sport on Prescription" in Primary Care for Patients With Long-term Illnesses (PRIMAPA-VAR)

Primary Purpose

Chronic Illness

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
"Cap Sport Santé 83" program
Sponsored by
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Illness focused on measuring Chronic disease, Adapted Physical Activity, Prescription, Quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient with a long-term illness (as set out by the french social security code) and a stabilised clinical condition
  • Aged 18 years old or over
  • Able to express his/her consent prior to participation in the study
  • 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

Sites / Locations

  • Maison Sport Santé 83Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Adapted Physical Activity (APA) program called "Cap Sport Santé 83"

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
Heart rate and heart rate variability measured with a heart rate monitor
Heart rate will be recorded
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.
To measure Body Mass Index (BMI)
Weight and height will be recorded.
To measure Blood pressure by tensiometer
Blood pressure will be recorded.
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
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.
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.
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.

Full Information

First Posted
June 24, 2022
Last Updated
October 23, 2023
Sponsor
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
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1. Study Identification

Unique Protocol Identification Number
NCT05437978
Brief Title
"Sport on Prescription" in Primary Care for Patients With Long-term Illnesses
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 19, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Illness
Keywords
Chronic disease, Adapted Physical Activity, Prescription, Quality of life

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
158 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adapted Physical Activity (APA) program called "Cap Sport Santé 83"
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
"Cap Sport Santé 83" program
Intervention Description
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.
Primary Outcome Measure Information:
Title
To evaluate the program impact on quality of life by the physical component of SF-36 questionnaire
Description
A high score corresponds to better health/quality of life.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
To evaluate the program impact on quality of life by the mental health and physical components of SF-36 questionnaire
Description
A high score corresponds to better health/quality of life.
Time Frame
Up to 12 months
Title
To evaluate physical activity by 6-minute walk test
Description
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.
Time Frame
Up to 12 months
Title
To evaluate physical activity by 30-Second Sit to Stand Test
Description
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.
Time Frame
Up to 12 months
Title
Physical activity and sedentary behaviour measured by the Global Physical Activity Questionnaire (GPAQ)
Description
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.
Time Frame
Up to 12 months
Title
Body composition measured by ultrasound and waist measurement.
Description
Total mass, percentage of fat mass, percentage of lean mass will be measured by ultrasound and recorded as well as waist measurement.
Time Frame
Up to 12 months
Title
Heart rate and heart rate variability measured with a heart rate monitor
Description
Heart rate will be recorded
Time Frame
Up to 12 months
Title
Quality of motivation to physical activity measured by the Motivation to Engage in Physical Activity in the Health Context Scale (EMAPS)
Description
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.
Time Frame
Up to 12 months
Title
To measure Body Mass Index (BMI)
Description
Weight and height will be recorded.
Time Frame
Up to 12 months
Title
To measure Blood pressure by tensiometer
Description
Blood pressure will be recorded.
Time Frame
Up to 12 months
Title
Physical activity and sedentary behaviour measured by accelerometry
Description
Accelerometry evaluate a subject's physical activity using sensors (accelerometers) that measure the body's accelerations and decelerations
Time Frame
Up to 6 months
Title
Balance function
Description
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.
Time Frame
Up to 12 months
Title
Hand muscle strength
Description
Hand muscle strength will be evaluated thank to a dynamometer which will have to be clutched as much as possible by the patient.
Time Frame
Up to 12 months
Title
Trunk flexibility
Description
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.
Time Frame
Up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sophie Lafond
Phone
04 83 77 20 62
Ext
+33
Email
sophie.lafond@ch-toulon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Magali Cesana
Phone
04 83 77 20 60
Ext
+33
Email
magali.cesana@ch-toulon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Marie LAMOULERE, MD
Organizational Affiliation
Maison Sport Santé 83
Official's Role
Study Director
Facility Information:
Facility Name
Maison Sport Santé 83
City
Toulon
State/Province
Var
ZIP/Postal Code
83000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Marie LAMOULERE, MD
Phone
04 94 46 01 92
Ext
+33
Email
jmlnad@yahoo.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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