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OBese Patients With Obstructive Sleep Apnea Syndrome(OSAS) and EXercise Training (OBEX1)
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| First Received Date ICMJE | June 30, 2010 | |||
| Last Updated Date | January 27, 2017 | |||
| Start Date ICMJE | July 2010 | |||
| Primary Completion Date | December 2014 (Final data collection date for primary outcome measure) | |||
| Current Primary Outcome Measures ICMJE |
Change in exercise tolerance during walking test [ Time Frame: After control period (6th wk) vs. after training period (18th wk) ]
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| Original Primary Outcome Measures ICMJE |
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) ]
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| Change History | Complete list of historical versions of study NCT01155271 on ClinicalTrials.gov Archive Site | |||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | |||
| Original Other Outcome Measures ICMJE | Not Provided | |||
| Descriptive Information | ||||
| Brief Title ICMJE | OBese Patients With Obstructive Sleep Apnea Syndrome(OSAS) and EXercise Training | |||
| Official Title ICMJE | Comparison of 3 Exercise Training Modalities in Obese Patient With Sleep Apnea Syndrome Treated by Continue Positive Airway Pressure : a Randomized Controlled Study | |||
| 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] |
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| 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. |
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| Study Type ICMJE | Interventional | |||
| Study Phase | Not Provided | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Outcomes Assessor Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | 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 |
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| Study Arms |
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| Publications * | Not Provided | |||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||
| Recruitment Status ICMJE | Active, not recruiting | |||
| Enrollment ICMJE | 60 | |||
| Estimated Completion Date | December 2018 | |||
| Primary Completion Date | December 2014 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years to 80 Years (Adult, Senior) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Canada, France | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT01155271 | |||
| Other Study ID Numbers ICMJE | AGIR-03 | |||
| Has Data Monitoring Committee | Yes | |||
| U.S. FDA-regulated Product | Not Provided | |||
| Plan to Share Data | Not Provided | |||
| IPD Description | Not Provided | |||
| Responsible Party | AGIR à Dom | |||
| Study Sponsor ICMJE | AGIR à Dom | |||
| Collaborators ICMJE | University Hospital, Grenoble | |||
| Investigators ICMJE |
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| PRS Account | AGIR à Dom | |||
| Verification Date | January 2017 | |||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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