Clinical trial NCT01155271: OBese Patients With Obstructive Sleep Apnea Syndrome(OSAS) and EXercise Training
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Sleep Apnea
Lead sponsor: AGIR à Dom
Sponsor class: OTHER
Collaborators: name: University Hospital, Grenoble
First posted: 2010-07-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 \[cycloergometer + spirotiger\]

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in exercise tolerance during walking test
timeFrame: After control period (6th wk) vs. after training period (18th wk)
Secondary outcomes:
measure: Changes in Aerobic capacity
timeFrame: After control period (6th wk) vs. after training period (18th and 52th wks)
measure: Changes in cardiovascular and metabolic function
timeFrame: After control period (6th wk) vs. after training period (18th and 52th wks)
measure: Changes in sleep parameters and Quality Of life
timeFrame: After control period (6th wk) vs. after training period (18th and 52th wks)
measure: Number of cardiovascular events per year
timeFrame: Every year from the 1st to the 5th year
measure: Changes in body composition
timeFrame: After control period (6th wk) vs. after training period (18th and 52th wks)
measure: Change in physical activity and sleep duration
timeFrame: After control period (6th wk) vs. after training period (18th and 52th wks)
measure: Change in exercise tolerance during walking test
timeFrame: After control period (6th wk) vs. after trainng (52th wk)
measure: Change in physiological variables during the control period
timeFrame: Before (1st) vs. after control period (6th wk)
measure: Baseline characteristics
timeFrame: Before control period (1st week) or after the control period (6th week)
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)
city: Grenoble
country: France
facility: Hopital Universitaire de Grenoble
Study officials:
affiliation: Laboratoire EFCR, CHU de Grenoble, 38043, Grenoble, France
name: Jean-Louis Pepin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vivodtzev I, Tamisier R, Croteau M, Borel JC, Grangier A, Wuyam B, Levy P, Minville C, Series F, Maltais F, Pepin JL. Ventilatory support or respiratory muscle training as adjuncts to exercise in obese CPAP-treated patients with obstructive sleep apnoea: a randomised controlled trial. Thorax. 2018 Feb 20:thoraxjnl-2017-211152. doi: 10.1136/thoraxjnl-2017-211152. Online ahead of print.