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

Comparison of 3 Exercise Training Modalities in Obese Patient With Sleep Apnea Syndrome Treated by Continue Positive Airway Pressure : a Randomized Controlled Study

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]

Study Overview

• Status: Unknown
• Conditions: Obesity; Sleep Apnea
• Intervention / Treatment: Other: Rehabilitation

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: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, GIV 4G5
    • Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)
• France
  • Grenoble, France, 38043
    • Hopital Universitaire de Grenoble

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ERGO; General endurance training on cycloergometer	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
Active Comparator: ERGONIV/ ERGOSPIRO; General endurance training on cycloergometer using ventilatory assistance (ERGONIV) or additional respiratory muscle training (ERGOSPIRO)	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in exercise tolerance during walking test	walking distance; dyspnea score	After control period (6th wk) vs. after training period (18th wk)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Aerobic capacity	Maximal oxygen consumption	After control period (6th wk) vs. after training period (18th and 52th wks)
Changes in cardiovascular and metabolic function	Pulse wave velocity, peripheral arterial tone, BP, inflammatory and metabolic plasmatic markers	After control period (6th wk) vs. after training period (18th and 52th wks)
Changes in sleep parameters and Quality Of life	Nocturnal oxygen saturation, CPAP data, Epworth questionnaire, Short Form (36) Health Survey questionnaire	After control period (6th wk) vs. after training period (18th and 52th wks)
Number of cardiovascular events per year	Questionnaire sent to the patient by mail	Every year from the 1st to the 5th year
Changes in body composition	Fat mass and fat-mass index Fat-free mass and fat-free mass index assessed by impedancemetry measurements	After control period (6th wk) vs. after training period (18th and 52th wks)
Change in physical activity and sleep duration	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	After control period (6th wk) vs. after training period (18th and 52th wks)
Change in exercise tolerance during walking test	isotime dyspnea; isotime oxygen saturation	After control period (6th wk) vs. after trainng (52th wk)
Change in physiological variables during the control period	functional and exercise parameters; cardiovascular parameters; metabolic parameters; sleep and quality of life parameters (Short Form (36) Health Survey); physical activity	Before (1st) vs. after control period (6th wk)
Baseline characteristics	functional and exercise parameters; cardiovascular parameters; metabolic parameters; sleep and quality of life parameters (Short Form (36) Health Survey); physical activity	Before control period (1st week) or after the control period (6th week)

Collaborators and Investigators

• Sponsor: AGIR à Dom
• Collaborators: University Hospital, Grenoble
• Investigators: Principal Investigator: Jean-Louis Pépin, MD, PhD, Laboratoire EFCR, CHU de Grenoble, 38043, Grenoble, France

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): December 1, 2014
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: June 30, 2010
• First Submitted That Met QC Criteria: June 30, 2010
• First Posted (Estimate): July 1, 2010

Study Record Updates

• Last Update Posted (Actual): October 2, 2018
• Last Update Submitted That Met QC Criteria: October 1, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Apnea
• Other Study ID Numbers: AGIR-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No