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

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ClinicalTrials.gov Identifier: NCT01155271
Recruitment Status : Unknown
Verified September 2018 by AGIR à Dom.
Recruitment status was:  Active, not recruiting
First Posted : July 1, 2010
Last Update Posted : October 2, 2018
Sponsor:
Collaborator:
University Hospital, Grenoble
Information provided by (Responsible Party):
AGIR à Dom

Study Description
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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]


Condition or disease Intervention/treatment Phase
Obesity Sleep Apnea Other: Rehabilitation Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : July 2010
Actual Primary Completion Date : December 2014
Estimated Study Completion Date : December 2018

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Change in exercise tolerance during walking test [ Time Frame: After control period (6th wk) vs. after training period (18th wk) ]
    • walking distance
    • dyspnea score


Secondary Outcome Measures :
  1. Changes in Aerobic capacity [ Time Frame: After control period (6th wk) vs. after training period (18th and 52th wks) ]
    Maximal oxygen consumption

  2. 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

  3. 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

  4. Number of cardiovascular events per year [ Time Frame: Every year from the 1st to the 5th year ]
    Questionnaire sent to the patient by mail

  5. 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

  6. 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

  7. Change in exercise tolerance during walking test [ Time Frame: After control period (6th wk) vs. after trainng (52th wk) ]
    • isotime dyspnea
    • isotime oxygen saturation

  8. 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

  9. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01155271


Locations
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Canada
Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)
Quebec, Canada, GIV 4G5
France
Hopital Universitaire de Grenoble
Grenoble, France, 38043
Sponsors and Collaborators
AGIR à Dom
University Hospital, Grenoble
Investigators
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Principal Investigator: Jean-Louis Pepin, MD, PhD Laboratoire EFCR, CHU de Grenoble, 38043, Grenoble, France
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AGIR à Dom
ClinicalTrials.gov Identifier: NCT01155271    
Other Study ID Numbers: AGIR-03
First Posted: July 1, 2010    Key Record Dates
Last Update Posted: October 2, 2018
Last Verified: September 2018
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
 Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases