Physical Activity Clinical Trial
— SESAMEOfficial title:
Study of the Determinants Associated With Sustained Changes in Physical Activity Behaviors, and Their Effects on the Prevention and Treatment of Chronic Diseases, in Individuals Enrolled in an Adapted Physical Activity Program
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.
Status | Recruiting |
Enrollment | 2024 |
Est. completion date | December 31, 2030 |
Est. primary completion date | January 31, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Male or female - 18 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. Exclusion Criteria: - Women whose pregnancy is known |
Country | Name | City | State |
---|---|---|---|
France | Mon Stade Sports Medicine Center | Paris |
Lead Sponsor | Collaborator |
---|---|
Mon Stade Sports Medicine Centre | General Mutual Insurance of National Education, France, Laboratory MOVE, Faculty of Sport Sciences, University of Poitiers, France, Public Health Foundation of MGEN, France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Effects on physical fitness: General measures: Weight | Body mass (Kg) measured on a balance | End of the APA program (between 4 and 9 months), 1 year, 2 years, 3 years, 4 years, 5 years | |
Other | Effects on physical fitness: General measures: Body mass index "BMI" | BMI (Kg/m²) = Weiht/(Height)² | End of the APA program (between 4 and 9 months), 1 year, 2 years, 3 years, 4 years, 5 years | |
Other | Effects on physical fitness: General measures: Waist circumference | Waist circumference (cm) measured in standing position with a tape measure | End of the APA program (between 4 and 9 months), 1 year, 2 years, 3 years, 4 years, 5 years | |
Other | Effects on physical fitness: General measures: Resting blood pressure | Blood pressure (BP) measured after 5 minutes rest in lying position (mm Hg) with an automatic BP device | End of the APA program (between 4 and 9 months), 1 year, 2 years, 3 years, 4 years, 5 years | |
Other | Effects on physical fitness: General measures: Resting heart rate | Heart rate after measured after 5 minutes rest in lying position (mm Hg) with the automatic BP device | End of the APA program (between 4 and 9 months), 1 year, 2 years, 3 years, 4 years, 5 years | |
Other | Body composition: DEXA scan: Fat mass | Total fat mass (g) measured with the DEXA scan | End of the APA program (between 4 and 9 months), 1 year, 2 years, 3 years, 4 years, 5 years | |
Other | Body composition: DEXA scan: Visceral fat mass | Visceral fat mass (cm²) measured with the DEXA scan | End of the APA program (between 4 and 9 months), 1 year, 2 years, 3 years, 4 years, 5 years | |
Other | Body composition: DEXA scan: Lean mass | Total lean mass (g) measured with the DEXA scan | End of the APA program (between 4 and 9 months), 1 year, 2 years, 3 years, 4 years, 5 years | |
Other | Body composition: DEXA scan: Bone mass | Total bone mass (g) measured with the DEXA scan | End of the APA program (between 4 and 9 months), 1 year, 2 years, 3 years, 4 years, 5 years | |
Other | Body composition: Impedance meter: Intracellular water | Volume of total body intracellular water (L) measured with the impedance meter | End of the APA program (between 4 and 9 months), 1 year, 2 years, 3 years, 4 years, 5 years | |
Other | Body composition: Impedance meter: Extracellular water | Volume of total body extracellular water (L) measured with the impedance meter | End of the APA program (between 4 and 9 months), 1 year, 2 years, 3 years, 4 years, 5 years | |
Other | Respiratory capacity (spirometry): Forced vital capacity "FVC" | Forced vital capacity (L) measured by spirometry before the cardiorespiratory exercise test | 5 years | |
Other | Respiratory capacity (spirometry): Forced expiratory volume in 1 second "FEV1" | Forced expiratory volume in 1 second (L) measured by spirometry before the cardiorespiratory exercise test | 5 years | |
Other | Respiratory capacity (spirometry): Peak expiratory flow "PEF" | Peak expiratory flow (L/min) measured by spirometry before the cardiorespiratory exercise test | 5 years | |
Other | Aerobic capacity (exercise stress test): Maximum aerobic power "MAP" if performed on Ergo-cycle | Maximum aerobic power (Watts) measured by a maximum incremental stress test performed on an ergo-cycle | End of the APA program (between 4 and 9 months), 1 year, 2 years, 3 years, 4 years, 5 years | |
Other | Aerobic capacity (exercise stress test): Maximum aerobic speed "MAS" if performed on Treadmill | Maximum aerobic speed (km/h) measured by a maximum incremental stress test performed on a treadmill | End of the APA program (between 4 and 9 months), 1 year, 2 years, 3 years, 4 years, 5 years | |
Other | Aerobic capacity (exercise stress test): METs max | METs max (METs) estimated by a maximum incremental stress test performed either on an ergo-cycle nor on a treadmill | End of the APA program (between 4 and 9 months), 1 year, 2 years, 3 years, 4 years, 5 years | |
Other | Aerobic capacity (exercise stress test): Heart rate max | Heart rate max (beats/min) measured by a maximum incremental stress test performed either on an ergo-cycle nor on a treadmill | End of the APA program (between 4 and 9 months), 1 year, 2 years, 3 years, 4 years, 5 years | |
Other | Aerobic capacity (exercise stress test): V'O2 max | V'O2 max (L/min) measured by a maximum incremental cardiorespiratory stress test performed either on an ergo-cycle nor on a treadmill | End of the APA program (between 4 and 9 months), 5 years | |
Other | Neuromuscular capacity: Maximum strength of lower limbs | Maximum strength of lower limbs (Kg) measured on a leg-press "Keiser® Air 420" | End of the APA program (between 4 and 9 months), 5 years | |
Other | Neuromuscular capacity: Maximum strength of upper limbs | Maximum strength of upper limbs (Kg) measured on a leg-press "Keiser® Air 420" | End of the APA program (between 4 and 9 months), 5 years | |
Other | Neuromuscular capacity: Lumbar muscular endurance | Lumbar muscular endurance using Sorensen Test (sec) | End of the APA program (between 4 and 9 months), 5 years | |
Other | Neuromuscular capacity: Abdominal muscular endurance | Abdominal muscular endurance using Shirado-Ito Test (sec) | End of the APA program (between 4 and 9 months), 5 years | |
Other | Neuromuscular capacity: Handgrip | Static handgrip strength test with a dynamometer (Newton) | End of the APA program (between 4 and 9 months), 5 years | |
Other | Neuromuscular capacity: Balance | One leg balance using Flamingo Balance Test (sec) | End of the APA program (between 4 and 9 months), 5 years | |
Other | Neuromuscular capacity: Flexibility | Trunk flexibility test using Sit-And-Reach Test (cm) | End of the APA program (between 4 and 9 months), 5 years | |
Primary | 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 | Behavioral analysis: Lifestyle habits: Accelerometer: Daily sedentary time | Changes in daily sedentary time (min) measured by wearing on the belt over 7 days an accelerometer "Actigraph wGT3X-BT" | End of the APA program (between 4 and 9 months), 1 year, 2 years, 3 years, 4 years, 5 years | |
Secondary | Behavioral analysis: Lifestyle habits: Accelerometer: Time in sitting, standing or lying down | Changes in Time in sitting, standing or lying down (min) measured by wearing on the belt over 7 days an accelerometer "Actigraph wGT3X-BT" | End of the APA program (between 4 and 9 months), 1 year, 2 years, 3 years, 4 years, 5 years | |
Secondary | Behavioral analysis: Lifestyle habits: Accelerometer: Number of steps | Changes in number of steps (n) measured by wearing on the belt over 7 days an accelerometer "Actigraph wGT3X-BT" | End of the APA program (between 4 and 9 months), 1 year, 2 years, 3 years, 4 years, 5 years | |
Secondary | Behavioral analysis: Lifestyle habits: Accelerometer: Average daily energy expenditure (KCal) | Changes in average daily energy expenditure (MET-min per day) measured by wearing on the belt over 7 days an accelerometer "Actigraph wGT3X-BT" | End of the APA program (between 4 and 9 months), 1 year, 2 years, 3 years, 4 years, 5 years | |
Secondary | Behavioral analysis: Lifestyle habits: Global Physical Activity Questionnaire "GPAQ" | Changes in average daily energy expenditure (MET-min per day) assessed by the Global Physical Activity Questionnaire "GPAQ" version 2 | End of the APA program (between 4 and 9 months), 1 year, 2 years, 3 years, 4 years, 5 years | |
Secondary | Behavioral analysis: Lifestyle habits: "Ricci & Gagnon" | Changes in average score of "Ricci & Gagnon" physical activity questionnaire (6-9: Not active; 10-18: Weakly active; 19-27: Moderately active; 28-36: Active; 37-45: Very active) | End of the APA program (between 4 and 9 months), 1 year, 2 years, 3 years, 4 years, 5 years | |
Secondary | Behavioral analysis: Lifestyle habits: "Ricci & Gagnon" vs. GPAQ | Corelation between average score of "Ricci & Gagnon" questionnaire and average daily energy expenditure (MET-min per day) assessed by the Global Physical Activity Questionnaire "GPAQ" version 2 | End of the APA program (between 4 and 9 months), 1 year, 2 years, 3 years, 4 years, 5 years | |
Secondary | Behavioral analysis: Lifestyle habits: "Ricci & Gagnon" vs. Accelerometer | Corelation between average score of "Ricci & Gagnon" questionnaire and average daily energy expenditure (MET-min per day) measured by wearing on the belt over 7 days an accelerometer "Actigraph wGT3X-BT"Activity Questionnaire "GPAQ" version 2 | End of the APA program (between 4 and 9 months), 1 year, 2 years, 3 years, 4 years, 5 years | |
Secondary | Behavioral analysis: Quality of life, psychological determinants: Eating habits | Changes in quality of eating habits using a dedicated questionnaire | End of the APA program (between 4 and 9 months), 5 years | |
Secondary | Behavioral analysis: Quality of life, psychological determinants: Alcohol consumption | Changes in quantity consumption of alcoholic beverages using a dedicated questionnaire | End of the APA program (between 4 and 9 months), 5 years | |
Secondary | Behavioral analysis: Quality of life, psychological determinants: Sleep | Changes in quality of sleep using a dedicated questionnaire | End of the APA program (between 4 and 9 months), 1 year, 2 years, 3 years, 4 years, 5 years | |
Secondary | Behavioral analysis: Quality of life, psychological determinants: WHOQOL-BREF | Changes in 4-class scores of World Health Organisation Quality of Life "WHOQOL-BREF" questionnaire (1. Physical Health; 2. Psychological Health; 3. Social Relations; 4. Environment) | End of the APA program (between 4 and 9 months), 1 year, 2 years, 3 years, 4 years, 5 years | |
Secondary | Behavioral analysis: Quality of life, psychological determinants: POMS | Changes in 7-class T-scores of Profile of mood states "POMS" questionnaire (1. anxiety; 2. anger; 3. fatigue; 4. Vigor; 5. Depression; 6. Confusion; 7. Interpersonal relationship) | End of the APA program (between 4 and 9 months), 1 year, 2 years, 3 years, 4 years, 5 years | |
Secondary | Behavioral analysis: Quality of life, psychological determinants: EMAPS | Changes in 6-class scores of Health Purpose Physical Activity Motivation Scale "Echelle de Motivation envers l'Activité Physique en contexte de Santé" "EMAPS" including the six forms of motivation underlined by self-determination theory (1. Intrinsic motivation; 2. Extrinsic motivation - integrated; 3. Extrinsic motivation - identified; 4. Extrinsic motivation - introjected; 5. Extrinsic motivation - external regulation; 6. Amotivation) | End of the APA program (between 4 and 9 months), 1 year, 2 years, 3 years, 4 years, 5 years | |
Secondary | Behavioral analysis: Quality of life, psychological determinants: QBAP | Changes in 7-class scores of Barriers to Physical Activity Practice Questionnaire "Questionnaire des Barrières à la Pratique d'ACtivité Physique" "QBAP" (1. Personal operation; 2. Social Support; 3. Temporal organization; 4. Knowledge and information; 5. Accessibility; 6. Skills, personality; 7. Disinterest) | End of the APA program (between 4 and 9 months), 1 year, 2 years, 3 years, 4 years, 5 years | |
Secondary | Behavioral analysis: Parameters associated with good adherence to the initial APA program | Good adherence defined by a =90% completion of the 2 weekly supervised sessions of the initial APA program over a period of 4 to 9 months | End of the APA program (between 4 and 9 months) | |
Secondary | Behavioral analysis: Parameters associated with persistence of physical activity practice over time | Persistence of physical activity (PA) practice defined by the observation of a positive trajectory of "moderate to vigorous" PA practice percentages collected by wearing an accelerometer for 7 days | 1 year, 2 years, 3 years, 4 years | |
Secondary | Medico-Economic Analysis: Care consumption | Changes in the volume of care consumption by subgroups of diseases using a dedicated questionnaire | 1 year, 2 years, 3 years, 4 years, 5 years | |
Secondary | Medico-Economic Analysis: Cost of the APA program: Direct costs | Cost of the program and care consumption (hospitalizations, consultations, medications) using a dedicated questionnaire | 1 year, 2 years, 3 years, 4 years, 5 years | |
Secondary | Medico-Economic Analysis: Cost of the APA program: Indirect costs | Monetary evaluation of caregivers' time for informal care, absenteeism, opportunity cost of the program for patients, using a dedicated questionnaire | 1 year, 2 years, 3 years, 4 years, 5 years | |
Secondary | Medico-Economic Analysis: Budget impact analysis | Budget impact analysis (BIA) of the APA program, which will mobilize MGEN medical-administrative and survey data, in order to estimate the difference in cost between SESAME cohorts and MGEN members who do not benefit from an APA, for population subgroups that are comparable in terms of age group and gender and according to their chronic diseases | 1 year, 2 years, 3 years, 4 years, 5 years | |
Secondary | Analysis of APA prescription: | Analysis of APA prescription using a dedicated questionnaire of perceived barriers to the medical prescription of APA | During the 4 years of participants' inclusion for the study |
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