Clinical trial NCT03087318: Sport as a Treatment in Chronic Diseases and Healthcare Sustainability
Official title: Sport as a Treatment in Chronic Diseases and Healthcare Sustainability: Sport 4 Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Overweight and Obesity
Keywords: Obstructive sleep apnea (OSA)
Overweight and moderate obesity
Sport prescription
Physical activity
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2017-03-22
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: at the end of the 3-month period
Secondary outcomes:
measure: Evaluation of the effect of the different programs of sport "prescription" on patient motivation
timeFrame: over a 3-month period
measure: Cost effectiveness analysis of the different programs of sport "prescription"
timeFrame: over a 3-month period.
measure: Evaluation of the effect of the different programs of sport "prescription" on weight and blood pressure (BP)
timeFrame: each month, over 3 months
Other outcomes:
Locations:
city: La Tronche
country: France
facility: University Hospital, Grenoble
Study officials:
affiliation: University Hospital of Grenoble, France
name: Jean-Louis Pépin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.