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

Obesity Clinical Trial

— OBEX1  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01155271
• Other study ID #: AGIR-03
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 2010
• Est. completion date: December 2018

Study information

• Verified date: September 2018
• Source: AGIR à Dom
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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]

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 2018
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obesity
• Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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

Locations

Country	Name	City	State
Canada	Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)	Quebec
France	Hopital Universitaire de Grenoble	Grenoble

Sponsors (2)

Lead Sponsor	Collaborator
AGIR à Dom	University Hospital, Grenoble

Countries where clinical trial is conducted

Canada,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in exercise tolerance during walking test	walking distance; dyspnea score	After control period (6th wk) vs. after training period (18th wk)
Secondary	Changes in Aerobic capacity	Maximal oxygen consumption	After control period (6th wk) vs. after training period (18th and 52th wks)
Secondary	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)
Secondary	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)
Secondary	Number of cardiovascular events per year	Questionnaire sent to the patient by mail	Every year from the 1st to the 5th year
Secondary	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)
Secondary	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)
Secondary	Change in exercise tolerance during walking test	isotime dyspnea; isotime oxygen saturation	After control period (6th wk) vs. after trainng (52th wk)
Secondary	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)
Secondary	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)