OBese Patients With Obstructive Sleep Apnea Syndrome(OSAS) and EXercise Training (OBEX1)

Tracking Information
First Submitted Date ICMJE	June 30, 2010
First Posted Date ICMJE	July 1, 2010
Last Update Posted Date	January 30, 2017
Study Start Date ICMJE	July 2010
Actual Primary Completion Date	December 2014 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: June 9, 2015)	Change in exercise tolerance during walking test [ Time Frame: After control period (6th wk) vs. after training period (18th wk) ]; walking distance; dyspnea score
Original Primary Outcome Measures ICMJE; (submitted: June 30, 2010)	Change in exercise tolerance during walking test [ Time Frame: Before and after control period (1st and 6th wks) vs. after training period (18th and 52th wks) ]; walking distance; isotime ventilation; isotime dysnpea score
Change History	Complete list of historical versions of study NCT01155271 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: June 9, 2015)	Changes in Aerobic capacity [ Time Frame: After control period (6th wk) vs. after training period (18th and 52th wks) ]Maximal oxygen consumption; Changes in cardiovascular and metabolic function [ Time Frame: After control period (6th wk) vs. after training period (18th and 52th wks) ]Pulse wave velocity, peripheral arterial tone, BP, inflammatory and metabolic plasmatic markers; Changes in sleep parameters and Quality Of life [ Time Frame: After control period (6th wk) vs. after training period (18th and 52th wks) ]Nocturnal oxygen saturation, CPAP data, Epworth questionnaire, Short Form (36) Health Survey questionnaire; Number of cardiovascular events per year [ Time Frame: Every year from the 1st to the 5th year ]Questionnaire sent to the patient by mail; Changes in body composition [ Time Frame: After control period (6th wk) vs. after training period (18th and 52th wks) ]Fat mass and fat-mass index Fat-free mass and fat-free mass index assessed by impedancemetry measurements; Change in physical activity and sleep duration [ Time Frame: After control period (6th wk) vs. after training period (18th and 52th wks) ]Number of hour per day of physical activity at 1, 2, 3 or 4 Metabolic Equivalents (METS); Number of steps per day; Sleep to lying position duration ratio; Change in exercise tolerance during walking test [ Time Frame: After control period (6th wk) vs. after trainng (52th wk) ] isotime dyspnea isotime oxygen saturation; Change in physiological variables during the control period [ Time Frame: Before (1st) vs. after control period (6th wk) ] functional and exercise parameters cardiovascular parameters metabolic parameters sleep and quality of life parameters (Short Form (36) Health Survey) physical activity; Baseline characteristics [ Time Frame: Before control period (1st week) or after the control period (6th week) ] functional and exercise parameters cardiovascular parameters metabolic parameters sleep and quality of life parameters (Short Form (36) Health Survey) physical activity
Original Secondary Outcome Measures ICMJE; (submitted: June 30, 2010)	Changes in cardiovascular and metabolic function [ Time Frame: Before and after control period (1st and 6th wks) vs. after training period (18th and 52th wks) ]Pulse wave velocity and pulse arterial tonus Inflammatory and metabolic plasmatic markers; Changes in Aerobic capacity [ Time Frame: Before and after control period (1st and 6th wks) vs. after training period (18th and 52th wks) ]Maximal oxygen consumption; Changes in sleep parameters [ Time Frame: Before and after control period (1st and 6th wks) vs. after training period (18th and 52th wks) ]Noctural oxigen saturation CPAP data Epworth questionnaire; Changes in Quality of life [ Time Frame: Before and after control period (1st and 6th wks) vs. after training period (18th and 52th wks) ]SF36 questionnaire; Number of cardiovascular events per year [ Time Frame: Every year from the 1st to the 5th year ]Questionnaire sent to the patient by mail
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	OBese Patients With Obstructive Sleep Apnea Syndrome(OSAS) and EXercise Training
Official Title ICMJE	Comparison of 3 Exercise Training Modalities in Obese Patient With Sleep Apnea Syndrome Treated by Continue Positive Airway Pressure : a Randomized Controlled Study
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.
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
Condition ICMJE	Obesity; Sleep Apnea
Intervention ICMJE	Other: 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
Study Arms	Active Comparator: ERGO General endurance training on cycloergometer Intervention: Other: Rehabilitation; Active Comparator: ERGONIV/ ERGOSPIRO General endurance training on cycloergometer using ventilatory assistance (ERGONIV) or additional respiratory muscle training (ERGOSPIRO) Intervention: Other: Rehabilitation
Publications *	Vivodtzev I, Tamisier R, Croteau M, Borel JC, Grangier A, Wuyam B, Lévy P, Minville C, Sériès F, Maltais F, Pépin 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. pii: thoraxjnl-2017-211152. doi: 10.1136/thoraxjnl-2017-211152. [Epub ahead of print]
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Active, not recruiting
Actual Enrollment ICMJE; (submitted: June 30, 2010)	60
Original Estimated Enrollment ICMJE	Same as current
Estimated Study Completion Date	December 2018
Actual Primary Completion Date	December 2014 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 80 Years (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Canada, France
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01155271
Other Study ID Numbers ICMJE	AGIR-03
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	AGIR à Dom
Study Sponsor ICMJE	AGIR à Dom
Collaborators ICMJE	University Hospital, Grenoble
Investigators ICMJE	Principal Investigator: Jean-Louis Pepin, MD, PhD Laboratoire EFCR, CHU de Grenoble, 38043, Grenoble, France
PRS Account	AGIR à Dom
Verification Date	January 2017
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP