Effect of Exercise Training on Obstructive Sleep Apnea Syndrome Severity

Not Applicable

Completed

• Conditions: Sleep Apnea Syndromes; Sleep Apnea, Obstructives
• Interventions: Other: Training; Other: Control

• Registration Number: NCT02463890
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-06-03
• Study First Submitted QC: 2015-06-03
• Study First Posted: 2015-06-04
• Study Start: 2015-06-08
• Primary Completion: 2017-09-04
• Study Completion: 2017-09-04
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-15
• Last Update Posted: 2018-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Training	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.
Control	Control	In this group, patients will receive only diets and physical activity counselling

Primary Outcome Measures

Name	Time	Method
Final polysomnography	9 months	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

Name	Time	Method
Epworth sleepiness Scale	9 months	Comparison of the variation of Epworth Sleepiness Scale (ESS) after 9 months follow-up for the two groups
First intermediate polysomnography	3 months	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	6 months	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	9 months	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
Pittsburgh questionnaire	9 months	Comparison of the variation of Pittsburgh questionnaire after 9 months follow-up for the two groups
Maximal aerobic capacity (VO2Max)	9 months	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)	9 months	Correlation between the change in daily physical activity energy expenditure (estimated by the POPAQ questionnaire) and AHI in the two groups
Berlin questionnaire	9 months	Comparison of the variation of Berlin questionnaire after 9 months follow-up for the two groups
Daily physical activity energy expenditure	9 months	Correlation between the daily physical activity energy expenditure (estimated directly by an actimetry sensor for 7 days) and AHI in the two groups
Blood pressure - Baroreflex	9 months	Measure of autonomic function (parasympathetic activity) - quantified via changes in blood pressure

Trial Locations

Locations (1)

CHU de Saint-Etienne; 🇫🇷 Saint-etienne, France