- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00406705
The Effect of Breathing Helium-Hyperoxia During Pulmonary Rehabilitation in Patients With COPD
A Randomized Controlled Trial to Study the Effect of Exercise Training Breathing Helium-Hyperoxia on The Exercise Tolerance and Quality of Life of Patients With Chronic Obstructive Pulmonary Disease
연구 개요
상세 설명
It is well accepted that the exercise training as part of a comprehensive pulmonary rehabilitation program can improve exercise tolerance, functional status and quality of life in patients with COPD. It is feasible that if patients were able to perform a greater volume or intensity of exercise during rehabilitation then the outcomes of the program would be improved. Recent research has demonstrated that breathing a helium-hyperoxic gas mixture can significantly reduce dynamic hyperinflation and dyspnea during exercise in patients with COPD and can increase exercise tolerance to a greater extent than breathing room air or a nitrogen-based hyperoxic gas. If patients with COPD were to breathe a helium-hyperoxic gas during exercise they should be able to tolerate a greater intensity of exercise while maintaining similar levels of exertional symptoms to those observed at lower exercise intensities breathing room air. As a result patients randomized to the helium-hyperoxia condition should obtain greater improvements in exercise tolerance than those receiving usual care (i.e. breathing room air)
Comparisons: Standard pulmonary rehabilitation of patients with COPD receiving either usual care (air breathing) or helium-hyperoxia (40% O2, 60% Helium).
연구 유형
등록
단계
- 2 단계
연락처 및 위치
연구 장소
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Alberta
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Edmonton, Alberta, 캐나다, T5K 0L4
- Caritas Centre for Lung Health
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- FEV1/FVC<70% predicted;
- FEV1<70% predicted;
- RV>140% predicted.
Exclusion Criteria:
- Cardiovascular contraindications to exercise;
- Musculoskeletal abnormalities that limit exercise tolerance;
- SpO2<85% during a constant work rate test;
- On supplemental oxygen.
- Exacerbation within the last month
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
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Constant-load exercise tolerance after 6 weeks of exercise rehabilitation
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2차 결과 측정
결과 측정 |
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Maximum oxygen consumption after 6 weeks of exercise rehabilitation
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Quality of Life measured after 6 weeks of exercise rehabilitation
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Dyspnea at an isotime during constant-load exercise after 6 weeks of exercise rehabilitation
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공동 작업자 및 조사자
수사관
- 수석 연구원: Neil D Eves, PhD, University of Calgary, AB, Canada
간행물 및 유용한 링크
일반 간행물
- Eves ND, Petersen SR, Haykowsky MJ, Wong EY, Jones RL. Helium-hyperoxia, exercise, and respiratory mechanics in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2006 Oct 1;174(7):763-71. doi: 10.1164/rccm.200509-1533OC. Epub 2006 Jul 13.
- Eves ND, Sandmeyer LC, Wong EY, Jones LW, MacDonald GF, Ford GT, Petersen SR, Bibeau MD, Jones RL. Helium-hyperoxia: a novel intervention to improve the benefits of pulmonary rehabilitation for patients with COPD. Chest. 2009 Mar;135(3):609-618. doi: 10.1378/chest.08-1517. Epub 2008 Nov 18.
연구 기록 날짜
연구 주요 날짜
연구 시작
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 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .