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
  Purpose

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 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:


Further study details as provided by AGIR à Dom:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 60
Study Start Date: July 2010
Estimated Study Completion Date: January 2018
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01155271

Locations
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
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: June 24, 2014
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
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Dyssomnias
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Disorders
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on October 23, 2014