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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-A00467-46 | Other Identifier | IdRCB |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rehabilitation medical center | Experimental | Physical activity:
|
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| Private sport club | Experimental | Physical activity:
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| Sport association | Experimental | Physical activity:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical activity | Behavioral | Physical activity:
|
| 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 |
| 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" |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Louis Pépin, MD, PhD | University Hospital of Grenoble, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital, Grenoble | La Tronche | 38700 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28117479 | Result | Andrade FM, Pedrosa RP. The role of physical exercise in obstructive sleep apnea. J Bras Pneumol. 2016 Nov-Dec;42(6):457-464. doi: 10.1590/S1806-37562016000000156. | |
| 21450560 | Result | Borjesson M, Urhausen A, Kouidi E, Dugmore D, Sharma S, Halle M, Heidbuchel H, Bjornstad HH, Gielen S, Mezzani A, Corrado D, Pelliccia A, Vanhees L. Cardiovascular evaluation of middle-aged/ senior individuals engaged in leisure-time sport activities: position stand from the sections of exercise physiology and sports cardiology of the European Association of Cardiovascular Prevention and Rehabilitation. Eur J Cardiovasc Prev Rehabil. 2011 Jun;18(3):446-58. doi: 10.1097/HJR.0b013e32833bo969. |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D050177 | Overweight |
| D009765 | Obesity |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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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.
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open, proof of concept study in overweight or moderate obese OSA patients,
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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 |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |