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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University Hospital, Grenoble
Information provided by (Responsible Party):
AGIR à Dom
ClinicalTrials.gov Identifier:
NCT01155271
First received: June 30, 2010
Last updated: June 24, 2014
Last verified: June 2013

June 30, 2010
June 24, 2014
July 2010
January 2014   (final data collection date for primary outcome measure)
Change in exercise tolerance during walking test [ Time Frame: After control period (6th wk) vs. after training period (18th wk) ] [ Designated as safety issue: No ]
  • walking distance
  • isotime dyspnea score
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 ventilation
  • isotime dysnpea score
Complete list of historical versions of study NCT01155271 on ClinicalTrials.gov Archive Site
  • Changes in cardiovascular and metabolic function [ Time Frame: After control period (6th wk) vs. after training period (18th and 52th wks) ] [ Designated as safety issue: No ]
    Pulse wave velocity, peripheral arterial tone, BP, inflammatory and metabolic plasmatic markers
  • Changes in Aerobic capacity [ Time Frame: After control period (6th wk) vs. after training period (18th and 52th wks) ] [ Designated as safety issue: No ]
    Maximal oxygen consumption
  • Changes in sleep parameters and Quality Of life [ Time Frame: After control period (6th wk) vs. after training period (18th and 52th wks) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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) ] [ 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: After control period (6th wk) 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 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) ] [ Designated as safety issue: No ]
    • walking distance
    • isotime dyspnea during walk
  • Change in physiological variables during the control period [ Time Frame: Before (1st) vs. after control period (6th wk) ] [ Designated as safety issue: No ]
    • 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) ] [ Designated as safety issue: No ]
    • functional and exercise parameters
    • cardiovascular parameters
    • metabolic parameters
    • sleep and quality of life parameters (Short Form (36) Health Survey)
    • physical activity
  • 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 ]
    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) ] [ 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
Not Provided
Not Provided
 
OBese Patients With Obstructive Sleep Apnea Syndrome(OSAS) and EXercise Training
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]

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Obesity
  • Sleep Apnea
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: 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
January 2018
January 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada,   France
 
NCT01155271
AGIR-03
Yes
AGIR à Dom
AGIR à Dom
University Hospital, Grenoble
Principal Investigator: Jean-Louis Pepin, MD, PhD Laboratoire EFCR, CHU de Grenoble, 38043, Grenoble, France
AGIR à Dom
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP