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Sport as a Treatment in Chronic Diseases and Healthcare Sustainability (S4H)

Grenoble Alpes University Hospital Center (CHU) logo

Grenoble Alpes University Hospital Center (CHU)

Status

Completed

Conditions

Overweight and Obesity
Obstructive Sleep Apnea

Treatments

Behavioral: Physical activity

Study type

Interventional

Funder types

Other

Identifiers

NCT03087318
38RC17.047
2017-A00467-46 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

25 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 3 patient groups

Rehabilitation medical center
Experimental group
Description:
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.
Treatment:
Behavioral: Physical activity
Private sport club
Experimental group
Description:
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.
Treatment:
Behavioral: Physical activity
Sport association
Experimental group
Description:
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.
Treatment:
Behavioral: Physical activity

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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