- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01930513
Exercise Capacity and Daily Physical Activity in Obese Subjects With Treated Obstructive Sleep Apnea
Obesity is very common worldwide and breathing problems at night (obstructive sleep apnea, OSA) are common in obesity. Despite the best treatment, obesity and OSA are linked to early death from heart problems. They are also associated with lower levels of physical activity. Exercise strategies for weight loss, increasing physical activity and improving fitness are needed for obesity. In Obese individuals with OSA
- The investigators will compare corridor walking tests compared to laboratory exercise tests. The null hypothesis is that the peak oxygen uptake achieved and the cardiopulmonary response during both the six-minute walk test and Incremental Shuttle Walk Test would not be different from that observed during an Incremental Treadmill Test.
- The investigators will investigate whether cycling or walking uses more calories for the same intensity. We hypothesise that cycling (weight supported) will be endured for long.
- The investigators will compare commonly used exercise tests with levels of daily physical activity.
The information from these three projects will help us set up the optimal exercise program for obese individuals.
연구 개요
상태
정황
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Ontario
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Toronto, Ontario, 캐나다, M6M 2J5
- West Park Healthcare Centre
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Obstructive Sleep Apnea
- Obesity BMI>30
- Controlled on Continuous Positive Airway Pressure for three months
Exclusion Criteria:
- cardiac co-morbidity e.g ischaemic heart disease, chronic heart failure, valvular heart disease
- pulmonary co-morbidity
- neurological condition limiting the ability to perform walking or cycling
- orthopaedic condition limiting the ability to perform walking or cycling
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Peak oxygen uptake (Peak VO2) measured at the end of the Incremental Shuttle Walk Test (ISWT)
기간: All outcome measures will be performed within four weeks of each other
|
Two Incremental Shuttle Walk tests will be performed within two hours on the same day with expired gas analysis measured by a portable gas analyser.
An ISWT is conducted over a 10m course and the speed is externally paced and increases each minute.
The participant is asked to continue until they are either too breathless or too tired to continue.
|
All outcome measures will be performed within four weeks of each other
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Six minute walk test (6MWT)
기간: Four weeks
|
The 6MWT will be performed over a 30 m level, straight course within an enclosed corridor.
The test protocol described by the American Thoracic Society will be modified to include standardized encouragement every 15 seconds to recommence walking if the participant chooses to rest during the test.
Participants will be familiarized with the test prior to participating in the study and, therefore, only one test will be performed.
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Four weeks
|
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Incremental Treadmill Test (ITM)
기간: Four weeks
|
A maximal treadmill test will be performed once with expired gas analysis.
|
Four weeks
|
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Incremental cycle test (ICE)
기간: Four weeks
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A maximal symptom limited cardio-pulmonary exercise test on a cycle ergometer.
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Four weeks
|
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Endurance cycle ergometer
기간: Four weeks
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Two endurance cycle tests will performed at 60% and 80% of the maximal peak oxygen obtained on either the ICE or ITM
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Four weeks
|
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Endurance treadmill test
기간: Four weeks
|
Constant speed endurance treadmill test will be performed at 60% and 80% of the peak oxygen uptake achieved on either the ITM or ICE to symptom limitation
|
Four weeks
|
|
Daily physical activity
기간: Four weeks
|
A sensewear armband will be worn for 7 days and only taken off for showering/bathing.
|
Four weeks
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Roger S Goldstein, MBChB, West Park Healthcare Centre
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- RG2010OSA
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