Health-Enhancing Adapted Physical Activity Program at "Mon Stade"

NCT04716322 | Recruiting

• 1 other identifier: 2020-A00254-35
• Study Type: interventional
• Target: 2,024
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Regular practice of exercise or physical activity (PA) is a recognized intervention as a determinant of good health acquisition, maintenance, or recovery for a large number of chronic pathologies. Nevertheless, few studies have evaluated adherence to an initial health-adapted PA (APA) program, and persistence of active behavior over the time in individuals with a chronic disease. The aim of the study is to determine the brakes and levers associated with motivation and long-term compliance. In addition, the investigators aim to evaluate the cost-effectiveness of such program in term of care consumption. Finally, the investigators complete their interest for APA prescription from practitioners agreeing to enroll their patients in the present study. Method: The investigators perform a prospective monocentric cohort, of 2024 patients affected of a chronic disease or long-term illness (LTI), enrolled from 2021 to 2024 (4 years, 506 per year), for a 16-week APA program, and followed 5 years with an annual fitness and habits of life and care consumption evaluation.

Conditions

Exercise Therapy; Behavior and Behavior Mechanisms; Adherence, Patient; Lifestyle, Sedentary; Life Style; Life Style, Healthy; Cost-Benefit Analysis; Prescriptions; Physical Activity; Adapted Physical Activity

Keywords

Adapted Physical Activity; Active Live Habits; Adherence; Aerobic Capacity; Behavior; Body Composition; Budget Impact Analysis; Cardiorespiratory Fitness; Care Consumption; Chronic Disease; DEXA scan; Exercise; Health-Adapted Physical Activity; Health-Enhancing; Life-Style; Long-Term Illness; Medico-Economic; Motivation; Perceived Barriers; Physical Activity; Physical Fitness; Prescription; Prevention; Psycho-social; Quality Of Life; Questionnaire; VO 2 measurement

Outcome Measures

Primary Outcomes (1)

• 5-year persistence of a positive trajectory of active behavior

  Study of the brakes and levers associated with the persistence at 5 years of an initial 16-week APA program, of a positive trajectory of the percentages of "moderate to vigorous" AP practice collected by wearing for 7 days a wGT3X-BT type accelerometer (Actigraph, Pensacola, FL, USA), illustrating the persistence of the favorable change in behavior eventually induced

  5 years

Secondary Outcomes (22)

• Behavioral analysis: Lifestyle habits: Accelerometer: Daily sedentary time

  End of the APA program (between 4 and 9 months), 1 year, 2 years, 3 years, 4 years, 5 years

• Behavioral analysis: Lifestyle habits: Accelerometer: Time in sitting, standing or lying down

  End of the APA program (between 4 and 9 months), 1 year, 2 years, 3 years, 4 years, 5 years

• Behavioral analysis: Lifestyle habits: Accelerometer: Number of steps

  End of the APA program (between 4 and 9 months), 1 year, 2 years, 3 years, 4 years, 5 years

• Behavioral analysis: Lifestyle habits: Accelerometer: Average daily energy expenditure (KCal)

  End of the APA program (between 4 and 9 months), 1 year, 2 years, 3 years, 4 years, 5 years

• Behavioral analysis: Lifestyle habits: Global Physical Activity Questionnaire "GPAQ"

  End of the APA program (between 4 and 9 months), 1 year, 2 years, 3 years, 4 years, 5 years

Other Outcomes (26)

• Effects on physical fitness: General measures: Weight

  End of the APA program (between 4 and 9 months), 1 year, 2 years, 3 years, 4 years, 5 years

• Effects on physical fitness: General measures: Body mass index "BMI"

  End of the APA program (between 4 and 9 months), 1 year, 2 years, 3 years, 4 years, 5 years

• Effects on physical fitness: General measures: Waist circumference

  End of the APA program (between 4 and 9 months), 1 year, 2 years, 3 years, 4 years, 5 years

Study Arms (1)

Adapted Physical Activity

OTHER

A 16-week health-adapted physical activity program and 5-year follow-up

Behavioral: Adapted Physical Activity

Interventions

Adapted Physical Activity BEHAVIORAL

A 16-week health-adapted physical activity program, individualized from baseline evaluation of participants including the specificities of their pathologies

Adapted Physical Activity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female
• years of age or older
• Speaking and understanding French
• Affected by a chronic pathology according to a predefined list (LTI, obesity, HTA, COPD, COVID-19 with persistent symptoms)
• Carrier of a writing APA prescription
• Able to come to "Mon Stade" twice a week for their APA sessions following the 16-week health-adapted PA program;
• Signature of the information and consent form.

You may not qualify if:

• \- Women whose pregnancy is known

Sponsors & Collaborators

• Mon Stade Sports Medicine Centre: lead
• Laboratory MOVE, Faculty of Sport Sciences, University of Poitiers, France: collaborator
• Public Health Foundation of MGEN, France: collaborator
• General Mutual Insurance of National Education, France: collaborator

Study Sites (1)

Mon Stade Sports Medicine Center

Paris, F-75013, France

RECRUITING

MeSH Terms

Conditions

Behavior; Patient Compliance; Sedentary Behavior; Motor Activity; Chronic Disease

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Philippe Sosner, MD, PhD

  Mon Stade Sports Medicine Center, Paris, France

  STUDY DIRECTOR

Central Study Contacts

Philippe Sosner, MD, PhD

CONTACT

+33144233004; psosner@monstade.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective monocentric cohort with consecutive inclusions of participants with chronic disease, and followed for 5 years after an initial 16-week physical activity program intervention

Study Record Dates

• First Submitted: December 23, 2020
• First Posted: January 20, 2021
• Study Start: January 28, 2021
• Primary Completion: January 31, 2025
• Study Completion (Estimated): December 31, 2030
• Last Updated: April 7, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)