Effect of Exercise Training on Obstructive Sleep Apnea Syndrome Severity (EXESAS)

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.

Study Overview

• Status: Completed
• Conditions: Sleep Apnea Syndromes; Sleep Apnea, Obstructives
• Intervention / Treatment: Other: Control; Other: Training

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint-etienne, France, 42000
    • CHU de Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Training; 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.	Other: Training; Other Names: NeuroGyV program
Other: Control; In this group, patients will receive only diets and physical activity counselling	Other: Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months
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.	6 months
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	9 months
Maximal aerobic capacity (VO2Max)	Correlation between the change in VO2max during stress test, walking distance during 6 minutes and AHI in the two groups	9 months
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	9 months
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	9 months
Epworth sleepiness Scale	Comparison of the variation of Epworth Sleepiness Scale (ESS) after 9 months follow-up for the two groups	9 months
Pittsburgh questionnaire	Comparison of the variation of Pittsburgh questionnaire after 9 months follow-up for the two groups	9 months
Berlin questionnaire	Comparison of the variation of Berlin questionnaire after 9 months follow-up for the two groups	9 months
Blood pressure - Baroreflex	Measure of autonomic function (parasympathetic activity) - quantified via changes in blood pressure	9 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Frederic ROCHE, MD - PhD, CHU de Saint-Etienne

Publications and helpful links

General Publications

• 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.

Helpful Links

• Website of the FFEPGV (in french)

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2015
• Primary Completion (Actual): September 4, 2017
• Study Completion (Actual): September 4, 2017

Study Registration Dates

• First Submitted: June 3, 2015
• First Submitted That Met QC Criteria: June 3, 2015
• First Posted (Estimate): June 4, 2015

Study Record Updates

• Last Update Posted (Actual): February 19, 2018
• Last Update Submitted That Met QC Criteria: February 15, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Training; Sleep Apnea Syndromes; Sleep Apnea, Obstructives
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disease; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Syndrome; Apnea
• Other Study ID Numbers: 1508033; 2015-A00490-49 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No