Effect of Exercise Training on Obstructive Sleep Apnea Syndrome Severity (EXESAS)
Primary Purpose
Sleep Apnea Syndromes, Sleep Apnea, Obstructives
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Training
Control
Sponsored by
About this trial
This is an interventional supportive care trial for Sleep Apnea Syndromes focused on measuring Sleep Apnea Syndromes, Sleep Apnea, Obstructives, Training
Eligibility Criteria
Inclusion Criteria:
- Patients affiliated or entitled to a social security system
- Patients with AHI from 15 to 30 per hour
- Signature of consent
Exclusion Criteria:
- Patients being already treated for sleep apnea or clinical status (cardiovascular comorbidities) justifying an immediate initiation of CPAP
- Daytime sleepiness (ESS score > 10)
- Known respiratory or heart disease (or discovering during stress test) contraindicated exercise training
- Patients with Parkinson's disease
Sites / Locations
- CHU de Saint-Etienne
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Training
Control
Arm Description
In this group, patients will perform 3 sessions of one hour per week of the "NeuroGyV" training program. It is a physical activity program with one session of Nordic walking, one session of "aquagym" and one session of gymnastic. Program lasts 9 months.
In this group, patients will receive only diets and physical activity counselling
Outcomes
Primary Outcome Measures
Final polysomnography
Percentage of patients with AHI < 15/hour through polysomnography assessment after nine months of follow-up in the training and the control groups
Secondary Outcome Measures
First intermediate polysomnography
Percentage of patients with AHI<15/hour through polysomnography assessment after three months of follow-up in the training and the control groups.
Second intermediate polysomnography
Percentage of patients with AHI<15/hour through polysomnography assessment after six months of follow-up in the training and the control groups.
High frequency
Correlation between change in AHI and change in high frequency (HF) of spectral analysis of heart rate variability (parasympathetic index) at 9 months of follow-up in the 2 groups
Maximal aerobic capacity (VO2Max)
Correlation between the change in VO2max during stress test, walking distance during 6 minutes and AHI in the two groups
Population Physical Activity questionnaire (POPAQ)
Correlation between the change in daily physical activity energy expenditure (estimated by the POPAQ questionnaire) and AHI in the two groups
Daily physical activity energy expenditure
Correlation between the daily physical activity energy expenditure (estimated directly by an actimetry sensor for 7 days) and AHI in the two groups
Epworth sleepiness Scale
Comparison of the variation of Epworth Sleepiness Scale (ESS) after 9 months follow-up for the two groups
Pittsburgh questionnaire
Comparison of the variation of Pittsburgh questionnaire after 9 months follow-up for the two groups
Berlin questionnaire
Comparison of the variation of Berlin questionnaire after 9 months follow-up for the two groups
Blood pressure - Baroreflex
Measure of autonomic function (parasympathetic activity) - quantified via changes in blood pressure
Full Information
NCT ID
NCT02463890
First Posted
June 3, 2015
Last Updated
February 15, 2018
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
1. Study Identification
Unique Protocol Identification Number
NCT02463890
Brief Title
Effect of Exercise Training on Obstructive Sleep Apnea Syndrome Severity
Acronym
EXESAS
Official Title
Effect of Exercise Training on Obstructive Sleep Apnea Syndrome Severity
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
June 8, 2015 (Actual)
Primary Completion Date
September 4, 2017 (Actual)
Study Completion Date
September 4, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
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
Sleep apnoea affects more than 20% of people over 65 years and is largely underdiagnosed. It does multiply tenfold the occurrence of vascular events, particularly stroke. While Continuous Positive Airway Pressure (CPAP) is currently the Gold standard treatment to prevent cerebrovascular and cardiovascular events, with a major clinical benefit, long term adherence to CPAP is a significant problem and search for alternative treatment is essential.
The investigators hypothesize that long-term exercise training would allow to reduce significantly sleep apnoea syndrome severity. Thus, in this study, the investigators will compare evolution of Apnoea Hypopnea Index (AHI) in an exercise trained group performed through in a national based non-profit organization (Fédération Française d'éducation Physique et de Gymnastique Volontaire (FFEPGV)) using a medical established program (NeuroGyV) during nine months against a control group receiving only standard dietetic and physical activity counseling.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea Syndromes, Sleep Apnea, Obstructives
Keywords
Sleep Apnea Syndromes, Sleep Apnea, Obstructives, Training
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Training
Arm Type
Experimental
Arm Description
In this group, patients will perform 3 sessions of one hour per week of the "NeuroGyV" training program. It is a physical activity program with one session of Nordic walking, one session of "aquagym" and one session of gymnastic. Program lasts 9 months.
Arm Title
Control
Arm Type
Other
Arm Description
In this group, patients will receive only diets and physical activity counselling
Intervention Type
Other
Intervention Name(s)
Training
Other Intervention Name(s)
NeuroGyV program
Intervention Type
Other
Intervention Name(s)
Control
Primary Outcome Measure Information:
Title
Final polysomnography
Description
Percentage of patients with AHI < 15/hour through polysomnography assessment after nine months of follow-up in the training and the control groups
Time Frame
9 months
Secondary Outcome Measure Information:
Title
First intermediate polysomnography
Description
Percentage of patients with AHI<15/hour through polysomnography assessment after three months of follow-up in the training and the control groups.
Time Frame
3 months
Title
Second intermediate polysomnography
Description
Percentage of patients with AHI<15/hour through polysomnography assessment after six months of follow-up in the training and the control groups.
Time Frame
6 months
Title
High frequency
Description
Correlation between change in AHI and change in high frequency (HF) of spectral analysis of heart rate variability (parasympathetic index) at 9 months of follow-up in the 2 groups
Time Frame
9 months
Title
Maximal aerobic capacity (VO2Max)
Description
Correlation between the change in VO2max during stress test, walking distance during 6 minutes and AHI in the two groups
Time Frame
9 months
Title
Population Physical Activity questionnaire (POPAQ)
Description
Correlation between the change in daily physical activity energy expenditure (estimated by the POPAQ questionnaire) and AHI in the two groups
Time Frame
9 months
Title
Daily physical activity energy expenditure
Description
Correlation between the daily physical activity energy expenditure (estimated directly by an actimetry sensor for 7 days) and AHI in the two groups
Time Frame
9 months
Title
Epworth sleepiness Scale
Description
Comparison of the variation of Epworth Sleepiness Scale (ESS) after 9 months follow-up for the two groups
Time Frame
9 months
Title
Pittsburgh questionnaire
Description
Comparison of the variation of Pittsburgh questionnaire after 9 months follow-up for the two groups
Time Frame
9 months
Title
Berlin questionnaire
Description
Comparison of the variation of Berlin questionnaire after 9 months follow-up for the two groups
Time Frame
9 months
Title
Blood pressure - Baroreflex
Description
Measure of autonomic function (parasympathetic activity) - quantified via changes in blood pressure
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients affiliated or entitled to a social security system
Patients with AHI from 15 to 30 per hour
Signature of consent
Exclusion Criteria:
Patients being already treated for sleep apnea or clinical status (cardiovascular comorbidities) justifying an immediate initiation of CPAP
Daytime sleepiness (ESS score > 10)
Known respiratory or heart disease (or discovering during stress test) contraindicated exercise training
Patients with Parkinson's disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederic ROCHE, MD - PhD
Organizational Affiliation
CHU de Saint-Etienne
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Saint-Etienne
City
Saint-etienne
ZIP/Postal Code
42000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30361248
Citation
Berger M, Barthelemy JC, Hupin D, Raffin J, Dupre C, Labeix P, Costes F, Gaspoz JM, Roche F. Benefits of supervised community physical activity in obstructive sleep apnoea. Eur Respir J. 2018 Nov 22;52(5):1801592. doi: 10.1183/13993003.01592-2018. Print 2018 Nov. No abstract available.
Results Reference
derived
Links:
URL
http://www.sport-sante.fr/accueil/
Description
Website of the FFEPGV (in french)
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Effect of Exercise Training on Obstructive Sleep Apnea Syndrome Severity
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