Overview

This trial is active, not recruiting.

Conditions obesity, sleep apnea
Treatment rehabilitation
Sponsor AGIR à Dom
Collaborator University Hospital, Grenoble
Start date July 2010
End date December 2014
Trial size 60 participants
Trial identifier NCT01155271, AGIR-03

Summary

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]

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
General endurance training on cycloergometer
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
(Active Comparator)
General endurance training on cycloergometer using ventilatory assistance (ERGONIV) or additional respiratory muscle training (ERGOSPIRO)
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

Primary Outcomes

Measure
Change in exercise tolerance during walking test
time frame: After control period (6th wk) vs. after training period (18th wk)

Secondary Outcomes

Measure
Changes in Aerobic capacity
time frame: After control period (6th wk) vs. after training period (18th and 52th wks)
Changes in cardiovascular and metabolic function
time frame: After control period (6th wk) vs. after training period (18th and 52th wks)
Changes in sleep parameters and Quality Of life
time frame: After control period (6th wk) vs. after training period (18th and 52th wks)
Number of cardiovascular events per year
time frame: Every year from the 1st to the 5th year
Changes in body composition
time frame: After control period (6th wk) vs. after training period (18th and 52th wks)
Change in physical activity and sleep duration
time frame: After control period (6th wk) vs. after training period (18th and 52th wks)
Change in exercise tolerance during walking test
time frame: After control period (6th wk) vs. after trainng (52th wk)
Change in physiological variables during the control period
time frame: Before (1st) vs. after control period (6th wk)
Baseline characteristics
time frame: Before control period (1st week) or after the control period (6th week)

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title Comparison of 3 Exercise Training Modalities in Obese Patient With Sleep Apnea Syndrome Treated by Continue Positive Airway Pressure : a Randomized Controlled Study
Principal investigator Jean-Louis Pepin, MD, PhD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by AGIR à Dom.