OBese Patients With Obstructive Sleep Apnea Syndrome(OSAS) and EXercise Training

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2018-12-31

Brief Summary

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The study was designed to test the following hypotheses:

In obese patients with OSAS, the benefit of the combination of exercise training + continuous positive airway pressure (CPAP) will be higher than CPAP alone in term of functional capacity, metabolic, inflammatory, cardiovascular and sleep parameters and quality of life.

In obese patients with OSAS, the benefit of training using ventilatory assistance (NIV) during cycloergometer \[cycloergometer with NIV\] or respiratory muscles training (spirotiger) in addition to cycloergometer \[cycloergometer + spirotiger\] will be higher than cycloergometer training alone \[cycloergometer\] in term of functional and exercise capacities.

Dyspnea during walking test and respiratory muscle strength at baseline could influence the response to combined exercise training such as \[cycloergometer + NIV\] or \[cycloergometer + spirotiger\]

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Detailed Description

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Background: Obesity and sleep apnea syndrome lead to metabolic troubles and increasing cardiovascular risk. Furthermore, both diseases are associated with reduced exercise tolerance. We hypothesized that exercise training could be complementary to nocturnal ventilatory treatment in restoring metabolic disturbances, exercise tolerance and sleep parameters in obese patients with SAS.

Objective: To evaluate the effect of training on exercise tolerance (walking distance and dyspnea during walk)(main objective), systemic inflammation, vascular endothelial function, insulin resistance, quality of sleep and quality of life in obese patients treated by CPAP for OSAS (secondary objectives)

Methods: We proposed to conduct a controlled, randomized clinical trial comparing the efficacy of 3 different modalities of training in obese patients with SAS. After a 6-week control pre-inclusion period, patients are included in either \[cycloergometer\] vs. \[cycloergometer with ventilatory assistance\] vs. \[cycloergometer + respiratory muscle exercises\]. Before and after the control period, and both immediately and 9 month after training, patients perform walking test, maximal incremental test on cycloergometer, blood sampling and cardiovascular function, body composition, muscle function, quality of sleep and quality of life assessments as well as spontaneous physical activity measurement. During the 5 years following inclusion in the training program, the number of cardiovascular event is recorded every year.

An interim analysis will be carried out when 30 will have completed the third evaluation session (after the training program). The Peto's method will be used to correct the p-values.

Conditions

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Obesity Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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ERGO

General endurance training on cycloergometer

Group Type ACTIVE_COMPARATOR

Rehabilitation

Intervention Type OTHER

12 weeks : 3 sessions per week (2 supervised sessions and 1 session at home)

1 technical visit and 1 nursing visit every two months at home for the CPAP

ERGONIV/ ERGOSPIRO

General endurance training on cycloergometer using ventilatory assistance (ERGONIV) or additional respiratory muscle training (ERGOSPIRO)

Group Type ACTIVE_COMPARATOR

Rehabilitation

Intervention Type OTHER

12 weeks : 3 sessions per week (2 supervised sessions and 1 session at home)

1 technical visit and 1 nursing visit every two months at home for the CPAP

Interventions

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Rehabilitation

12 weeks : 3 sessions per week (2 supervised sessions and 1 session at home)

1 technical visit and 1 nursing visit every two months at home for the CPAP

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* OSAS (AHI \> 30 before CPAP treatment)
* \> 4h/d CPAP treatment adherence
* Obese patients with 35 \< BMI \< 45 kg/m2
* Patients who give written consent
* Patients who subscribed social insurance

Exclusion Criteria

* Cardiovascular or respiratory failure discovered at the moment of the inclusion in the study
* Contraindication to exercise
* Pregnant or breast-feed woman
* Patients under guardianship
* Imprisoned patients

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No