OBese Patients With Obstructive Sleep Apnea Syndrome(OSAS) and EXercise Training (OBEX1)
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]
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: ERGO
General endurance training on cycloergometer
|
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 |
|
활성 비교기: ERGONIV/ ERGOSPIRO
General endurance training on cycloergometer using ventilatory assistance (ERGONIV) or additional respiratory muscle training (ERGOSPIRO)
|
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 |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in exercise tolerance during walking test
기간: After control period (6th wk) vs. after training period (18th wk)
|
|
After control period (6th wk) vs. after training period (18th wk)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Changes in Aerobic capacity
기간: After control period (6th wk) vs. after training period (18th and 52th wks)
|
Maximal oxygen consumption
|
After control period (6th wk) vs. after training period (18th and 52th wks)
|
|
Changes in cardiovascular and metabolic function
기간: After control period (6th wk) vs. after training period (18th and 52th wks)
|
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)
|
|
Changes in sleep parameters and Quality Of life
기간: After control period (6th wk) vs. after training period (18th and 52th wks)
|
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
기간: Every year from the 1st to the 5th year
|
Questionnaire sent to the patient by mail
|
Every year from the 1st to the 5th year
|
|
Changes in body composition
기간: After control period (6th wk) vs. after training period (18th and 52th wks)
|
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
기간: After control period (6th wk) vs. after training period (18th and 52th wks)
|
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
기간: After control period (6th wk) vs. after trainng (52th wk)
|
|
After control period (6th wk) vs. after trainng (52th wk)
|
|
Change in physiological variables during the control period
기간: Before (1st) vs. after control period (6th wk)
|
|
Before (1st) vs. after control period (6th wk)
|
|
Baseline characteristics
기간: Before control period (1st week) or after the control period (6th week)
|
|
Before control period (1st week) or after the control period (6th week)
|
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Jean-Louis Pépin, MD, PhD, Laboratoire EFCR, CHU de Grenoble, 38043, Grenoble, France
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- AGIR-03
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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