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

Sponsor
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05437978
Collaborator
(none)
158
1
1
29
5.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: "Cap Sport Santé 83" program
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
158 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
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
Anticipated Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Sep 1, 2024
Anticipated Study Completion Date :
Mar 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Adapted Physical Activity (APA) program called "Cap Sport Santé 83"

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.

Outcome Measures

Primary Outcome Measures

  1. To evaluate of impact on quality of life by the physical component of SF-36 questionnaire [6 months]

    A high score corresponds to better health/quality of life.

Secondary Outcome Measures

  1. To evaluate impact on quality of life by the mental health and physical components of the SF-36 questionnaire [Up to 12 months]

    A high score corresponds to better health/quality of life.

  2. To evaluate physical activity by 6-minute walk test [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.

  3. To evaluate physical activity by 30-Second Sit to Stand Test [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.

  4. Physical activity and sedentary behaviour measured by the Global Physical Activity Questionnaire (GPAQ) [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.

  5. Body composition measured by ultrasound and waist measurement. [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.

  6. Heart rate and heart rate variability measured with a heart rate monitor [Up to 12 months]

    Heart rate will be recorded

  7. Perceived enjoyment of physical activity measured by the Physical Activity Enjoyment Scale (PACES) [Up to 12 months]

    Total score ranges from 10 to 70. The higher the total score, the greater the perceived pleasure.

  8. Quality of motivation to physical activity measured by the Motivation to Engage in Physical Activity in the Health Context Scale (EMAPS) [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.

  9. To measure Body Mass Index (BMI) [Up to 12 months]

    Weight and height will be recorded.

  10. To measure Blood pressure by tensiometer [Up to 12 months]

    Blood pressure will be recorded.

  11. Physical activity and sedentary behaviour measured by accelerometry [Up to 12 months]

    Accelerometry evaluate a subject's physical activity using sensors (accelerometers) that measure the body's accelerations and decelerations

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Maison Sport Santé 83 Toulon Var France 83000

Sponsors and Collaborators

  • Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Investigators

  • Study Director: Jean-Marie LAMOULERE, MD, Maison Sport Santé 83

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
ClinicalTrials.gov Identifier:
NCT05437978
Other Study ID Numbers:
  • 2022-CHITS-001
  • 2022-A00712-41
First Posted:
Jun 29, 2022
Last Update Posted:
Jun 29, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 29, 2022