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

Primary Purpose

Obstructive Sleep Apnea, Overweight and Obesity

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Physical activity
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Obstructive Sleep Apnea focused on measuring Obstructive sleep apnea (OSA), Overweight and moderate obesity, Sport prescription, Physical activity

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University Hospital, Grenoble

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Rehabilitation medical center

Private sport club

Sport association

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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.
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

Full Information

First Posted
March 16, 2017
Last Updated
February 21, 2018
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT03087318
Brief Title
Sport as a Treatment in Chronic Diseases and Healthcare Sustainability
Acronym
S4H
Official Title
Sport as a Treatment in Chronic Diseases and Healthcare Sustainability: Sport 4 Health
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
April 5, 2017 (Actual)
Primary Completion Date
February 15, 2018 (Actual)
Study Completion Date
February 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Overweight and Obesity
Keywords
Obstructive sleep apnea (OSA), Overweight and moderate obesity, Sport prescription, Physical activity

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Masking Description
open, proof of concept study in overweight or moderate obese OSA patients,
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rehabilitation medical center
Arm Type
Experimental
Arm 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.
Arm Title
Private sport club
Arm Type
Experimental
Arm 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.
Arm Title
Sport association
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Physical activity
Other Intervention Name(s)
Programs of sport "prescription"
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
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).
Time Frame
at the end of the 3-month period
Secondary Outcome Measure Information:
Title
Evaluation of the effect of the different programs of sport "prescription" on patient motivation
Description
The evaluation of the effect of the different programs of sport "prescription" on patient motivation will be assessed by a motivational questionnaire.
Time Frame
over a 3-month period
Title
Cost effectiveness analysis of the different programs of sport "prescription"
Description
Monthly cost of the subscription in the sport association, private sport club and rehabilitation medical center will be collected.
Time Frame
over a 3-month period.
Title
Evaluation of the effect of the different programs of sport "prescription" on weight and blood pressure (BP)
Description
Monthly self measurement of weight and BP at home, recorded in the application
Time Frame
each month, over 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Louis Pépin, MD, PhD
Organizational Affiliation
University Hospital of Grenoble, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital, Grenoble
City
La Tronche
ZIP/Postal Code
38700
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28117479
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.
Results Reference
result
PubMed Identifier
21450560
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.
Results Reference
result

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Sport as a Treatment in Chronic Diseases and Healthcare Sustainability

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