Sport as a Treatment in Chronic Diseases and Healthcare Sustainability

Obstructive Sleep Apnea Clinical Trial

— S4H  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03087318
• Other study ID #: 38RC17.047
• Secondary ID: 2017-A00467-46
• Status: Completed
• Phase: N/A
• First received: March 16, 2017
• Last updated: February 21, 2018
• Start date: April 5, 2017
• Est. completion date: February 15, 2018

Study information

• Verified date: February 2018
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 15, 2018
• Est. primary completion date: February 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Disease
• Obstructive Sleep Apnea
• Overweight
• Overweight and Obesity
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Behavioral:
• Physical activity
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.

Locations

Country	Name	City	State
France	University Hospital, Grenoble	La Tronche

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (2)

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. Review. English, Portuguese. — View Citation

Borjesson M, Urhausen A, Kouidi E, Dugmore D, Sharma S, Halle M, Heidbüchel H, Björnstad HH, Gielen S, Mezzani A, Corrado D, Pelliccia A, Vanhees L. Cardiovascular evaluation of middle-aged/ senior individuals engaged in leisure-time sport activities: pos — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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.
Secondary	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