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

This study is currently recruiting participants.
Verified October 2010 by AGIR à Dom
Sponsor:
Collaborator:
University Hospital, Grenoble
Information provided by (Responsible Party):
AGIR à Dom
ClinicalTrials.gov Identifier:
NCT01155271
First received: June 30, 2010
Last updated: January 15, 2013
Last verified: October 2010
History of Changes
  Purpose

The study was designed to test the following hypotheses:

In obese patients with OSAS, the benefit of the combination of exercise training + 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 ergocycle will be higher than ergocycle without NIV in term of exercise duration and performance

In obese patients with OSAS, the benefit of both peripheral and respiratory muscles training (ergocycle + spirotiger) will be higher than peripheral muscle training alone (ergocycle) in term of exercise duration and performance and respiratory muscle strength

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


Condition Intervention
Obesity
Sleep Apnea
 Other: Rehabilitation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AGIR à Dom:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    • walking distance
    • isotime dyspnea score


Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    Nocturnal oxygen 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) ] [ Designated as safety issue: No ]
    SF36 questionnaire

  • Number of cardiovascular events per year [ Time Frame: Every year from the 1st to the 5th year ] [ Designated as safety issue: No ]
    Questionnaire sent to the patient by mail

  • Changes in body composition [ Time Frame: Before and after control period (1st and 6th wks) vs. after training period (18th and 52th wks) ] [ Designated as safety issue: No ]
    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: Before and after control period (1st and 6th wks) vs. after training period (18th and 52th wks) ] [ Designated as safety issue: No ]
    Number of hour per day of physical activity at 1, 2, 3 or 4 METS Number of steps per day sleep to lying position duration ratio


Estimated Enrollment: 60
Study Start Date: July 2010
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ERGO
General endurance training using Ergocycle
 Other: Rehabilitation

6 weeks control period - (1 technical visit and 1 nursing visit every two months at home)

+ 12 weeks : 3 sessions per week (2 supervised sessions and 1 session at home)
Active Comparator: ERGONIV
General endurance training using Ergocycle with ventilatory assistance
 Other: Rehabilitation

6 weeks control period - (1 technical visit and 1 nursing visit every two months at home)

+ 12 weeks : 3 sessions per week (2 supervised sessions and 1 session at home)
Active Comparator: ERGOSPIRO
General endurance training using Ergocycle + Respiratory muscle training
 Other: Rehabilitation

6 weeks control period - (1 technical visit and 1 nursing visit every two months at home)

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

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 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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • OSAS (AHI > 30) with CPAP treatment and > 4h observance per night
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01155271

Contacts
Contact: Jean-Louis Pepin, MD, PhD 476765516 JPepin@chu-grenoble.fr
Contact: Isabelle Vivodtzev, PhD 476510304 i.vivodtzev@agiradom.com

Locations
Canada
Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ) Recruiting
Quebec, Canada, GIV 4G5
Contact: François Maltais, Dr     418-656-8711     Francois.Maltais@fmed.ulaval.ca    
Contact: Isabelle Vivodtzev, PhD     33(0)476510304     i.vivodtzev@agiradom.com    
France
Hopital Universitaire de Grenoble Recruiting
Grenoble, France, 38043
Contact: Jean-Louis Pepin, MD, PhD     +33(0)476765516     JPepin@chu-grenoble.fr    
Contact: Isabelle Vivodtzev, PhD     +33(0)476510304     i.vivodtzev@agiradom.com    
Sponsors and Collaborators
AGIR à Dom
University Hospital, Grenoble
Investigators
Principal Investigator: Jean-Louis Pepin, MD, PhD Laboratoire EFCR, CHU de Grenoble, 38043, Grenoble, France
  More Information

No publications provided

Responsible Party: AGIR à Dom
ClinicalTrials.gov Identifier: NCT01155271     History of Changes
Other Study ID Numbers: AGIR-03
Study First Received: June 30, 2010
Last Updated: January 15, 2013
Health Authority: France: national consultative ethics comity for health and life sciences
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Apnea
Obesity
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
 Overnutrition
Nutrition Disorders
Overweight
Body Weight
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on May 21, 2013