Effect of Exercise Training on Obstructive Sleep Apnea Syndrome Severity

NCT ID: NCT02463890

Last Updated: 2018-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-08

Study Completion Date

2017-09-04

Brief Summary

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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

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Conditions

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Sleep Apnea Syndromes Sleep Apnea, Obstructives

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Training

Intervention Type OTHER

Control

In this group, patients will receive only diets and physical activity counselling

Group Type OTHER

Control

Intervention Type OTHER

Interventions

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Training

Intervention Type OTHER

Control

Intervention Type OTHER

Other Intervention Names

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NeuroGyV program

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frederic ROCHE, MD - PhD

Role: PRINCIPAL_INVESTIGATOR

CHU de Saint-Etienne

Locations

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CHU de Saint-Etienne

Saint-Etienne, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 30361248 (View on PubMed)

Related Links

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http://www.sport-sante.fr/accueil/

Website of the FFEPGV (in french)

Other Identifiers

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2015-A00490-49

Identifier Type: OTHER

Identifier Source: secondary_id

1508033

Identifier Type: -

Identifier Source: org_study_id

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