Follow-up of the Patients Included in the EXESAS Study

NCT ID: NCT02920723

Last Updated: 2018-11-05

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

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-01

Study Completion Date

2018-08-21

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.

Detailed Description

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In the previous EXESAS study (NCT02463890) the investigators compare evolution of Apnea 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.

The first partial observations of the study EXESAS seem encouraging in the term of 3 months of training. However, in the longer term, there is not a coverage in the treatment of the moderate Sleep Apnea: Obstructive Syndrome (SAOS). Thus they can logically expect that the possible therapeutic effect of the exercise is not maintained in the long term after the stop of the training.

This nex study suggests studying the profit of the exercise on sleep apneas for the patients who were initially in the control group in the EXESAS study and to observe if the preservation of a regular physical activity for the group which was trained in EXESAS study is associated with a preservation of the AHI after the additional year of follow-up without additional intervention

Conditions

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Sleep Apnea Syndromes Sleep Apnea, Obstructives

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Training

For the patients who were allocated in the control group in the EXESAS study. 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

For the patients who were allocated in the training group in the EXESAS study. 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

* Included in the previous EXESAS study
* 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
* AHI \> 30
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

Related Links

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

Website of the FFEPGV (in french)

Other Identifiers

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2016-A00859-42

Identifier Type: OTHER

Identifier Source: secondary_id

1608082

Identifier Type: -

Identifier Source: org_study_id

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