Sport as a Treatment in Chronic Diseases and Healthcare Sustainability

Study Overview
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Brief Summary
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Obesity, associated with obstructive sleep apnea (OSA) is often involved in cardiovascular diseases. In our study, we want to promote sport practice to reduce that burden in the first place, and all associated diseases (e.g. cardiovascular diseases) consequently. The aim of this clinical trial is to determine which type of program, conducted in a digital environment associating a mobile application and individual coaching, better improves exercise habits over a 3-month period in overweight or moderate obese OSA patients.

Detailed Description
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With automation equipment and the comfort, it has brought, less natural physical activities are required and people do not take the time to do some. Therefore, obesity, associated with obstructive sleep apnea (OSA) up to 60% of cases, has become a heavy burden on the society and the healthcare system, besides the fact that it often involves cardiovascular diseases. Assistance is urgently needed and the investigators want to promote sport practice to reduce that burden in the first place, and all associated diseases (e.g. cardiovascular diseases) consequently. In order to do that, the investigators will integrate sport in the patient pathway and support in his/her involvement. This last point means that a link between medical and sport specialists should be established, and this is missing today. This study aims to reconcile the world of patients and the world of sport, by offering a trajectory and an organization that help patients to initiate physical activity. The investigators plan to measure the physical activity of overweight or moderate obese, apneic patients in the different programs at the end of the 3-month period by physical activity objective parameters: number of steps/day. The secondary objectives of this study are to: Evaluate the effect of the different programs of sport prescription on patient motivation, over a 3-month period by a motivational questionnaire. Analyze the cost effectiveness of the different programs of sport prescription over a 3-month period. Evaluate the effect of the different programs of sport prescription on weight and blood pressure (BP), assessed by home self-measurements each month, over a 3-month period and recorded in the application.

Official Title
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Sport as a Treatment in Chronic Diseases and Healthcare Sustainability: Sport 4 Health

Conditions
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Obstructive Sleep Apnea, Overweight and Obesity

Intervention / Treatment
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* Behavioral: Physical activity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 25 y ≤ age ≤ 70 y 27 < BMI < 32 Weight < 120 kg Apneic patient (Apnea-hypopnea index > 15/h) treated or not by CPAP (continuous positive airway pressure ) Be able to practice sport (according to a Cardiologist decision) Be able to use the personal health monitoring devices jointly to a personal Touch phone Consenting patient based around Grenoble France Be legally able to give consent Person affiliated to social security Exclusion Criteria: Being unable to understand, follow objectives and methods due to cognition or language problems Pregnant women, feeding and parturient Physical activity score > 9, calculated by Baecke's questionnaire (Annex 1) Subject under administrative or judicial control, person who are protected under the act.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, open, proof of concept study in overweight or moderate obese OSA patients, comparing 3 different programs of sport prescription: patient's referred to a rehabilitation medical center, to a private sport club or to a sport association.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rehabilitation medical center<br>Physical activity: 3 sessions / week at least at least during 30 minutes each session at least at 50% of the maximal HR(heart rate) measured during the exercise stress testing (from the screening) during 3 months. | Behavioral: Physical activity<br>* Physical activity: 3 sessions / week at least at least during 30 minutes each session at least at 50% of the maximal heart rate measured during the exercise stress testing (from the screening) during 3 months.<br>* Other names: Programs of sport prescription;|
| Experimental: Private sport club<br>Physical activity: 3 sessions / week at least at least during 30 minutes each session at least at 50% of the maximal HR(heart rate) measured during the exercise stress testing (from the screening) during 3 months. | Behavioral: Physical activity<br>* Physical activity: 3 sessions / week at least at least during 30 minutes each session at least at 50% of the maximal heart rate measured during the exercise stress testing (from the screening) during 3 months.<br>* Other names: Programs of sport prescription;|
| Experimental: Sport association<br>Physical activity: 3 sessions / week at least at least during 30 minutes each session at least at 50% of the maximal HR(heart rate) measured during the exercise stress testing (from the screening) during 3 months. | Behavioral: Physical activity<br>* Physical activity: 3 sessions / week at least at least during 30 minutes each session at least at 50% of the maximal heart rate measured during the exercise stress testing (from the screening) during 3 months.<br>* Other names: Programs of sport prescription;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The physical activity of overweight or moderate obese OSA patients in the different programs will be estimated by physical activity objective parameters: number of steps/day. | The physical activity of overweight or moderate obese OSA patients in the different programs during the 3-month period will be estimated by physical activity objective parameters: heart rate, physical activity type, motion cadence (number of steps/day), energy expenditure, and sleep stage (measured at the end, by an actigraph integrated in the watch). | at the end of the 3-month period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the effect of the different programs of sport prescription on patient motivation | The evaluation of the effect of the different programs of sport prescription on patient motivation will be assessed by a motivational questionnaire. | over a 3-month period | 
| Cost effectiveness analysis of the different programs of sport prescription | Monthly cost of the subscription in the sport association, private sport club and rehabilitation medical center will be collected. | over a 3-month period. | 
| Evaluation of the effect of the different programs of sport prescription on weight and blood pressure (BP) | Monthly self measurement of weight and BP at home, recorded in the application | each month, over 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obstructive sleep apnea (OSA), Overweight and moderate obesity, Sport prescription, Physical activity