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| Name | Class |
|---|---|
| University Hospital, Grenoble | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ERGO | Active Comparator | General endurance training on cycloergometer |
|
| ERGONIV/ ERGOSPIRO | Active Comparator | General endurance training on cycloergometer using ventilatory assistance (ERGONIV) or additional respiratory muscle training (ERGOSPIRO) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rehabilitation | Other | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in exercise tolerance during walking test |
| After control period (6th wk) vs. after training period (18th wk) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Aerobic capacity | Maximal oxygen consumption | After control period (6th wk) vs. after training period (18th and 52th wks) |
| Changes in cardiovascular and metabolic function | Pulse wave velocity, peripheral arterial tone, BP, inflammatory and metabolic plasmatic markers |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Louis Pepin, MD, PhD | Laboratoire EFCR, CHU de Grenoble, 38043, Grenoble, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ) | Québec | GIV 4G5 | Canada | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29463621 | Derived | Vivodtzev I, Tamisier R, Croteau M, Borel JC, Grangier A, Wuyam B, Levy P, Minville C, Series F, Maltais F, Pepin JL. Ventilatory support or respiratory muscle training as adjuncts to exercise in obese CPAP-treated patients with obstructive sleep apnoea: a randomised controlled trial. Thorax. 2018 Feb 20:thoraxjnl-2017-211152. doi: 10.1136/thoraxjnl-2017-211152. Online ahead of print. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| ID | Term |
|---|---|
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
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| After control period (6th wk) vs. after training period (18th and 52th wks) |
| 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) |
| Number of cardiovascular events per year | Questionnaire sent to the patient by mail | Every year from the 1st to the 5th year |
| 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) |
| 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) |
| Change in exercise tolerance during walking test |
| After control period (6th wk) vs. after trainng (52th wk) |
| Change in physiological variables during the control period |
| Before (1st) vs. after control period (6th wk) |
| Baseline characteristics |
| Before control period (1st week) or after the control period (6th week) |
| Hopital Universitaire de Grenoble |
| Grenoble |
| 38043 |
| France |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D006296 |
| Health Services |
| D005159 | Health Care Facilities Workforce and Services |