- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01367197
Study of the Effect of Exercise Training on Patients in Atrial Fibrillation
Randomised Study of the Effect of Exercise Training on Patients in Atrial Fibrillation
PURPOSE Physical exercise is beneficial for patients with ischemic heart disease and chronic heart failure, while little is known about the effect in atrial fibrillation (AF). The investigators studied the effect of physical exercise on cardiac output (CO), max. exercise capacity, biomarkers and quality of life (Qol) in patients with AF in a randomised study of physical exercise training three times weekly for twelve weeks.
HYPOTHESIS Exercise training improves cardiac output (CO), max. exercise capacity, biomarkers and quality of life (Qol) in patients with AF.
METHODS Assessment of exercise capacity, CO, Qol, body composition, six minute walk test and muscular strength was performed before and after 12 weeks.
Resting echocardiography was done at baseline. CO was measured using impedance cardiography at rest and during maximal exercise testing on an ergometer bicycle. Body composition, muscular strength and six minutes walking capacity were measured before and after the training period. Qol was evaluated by the use of the standardized validated questionnaires Short Form 36 (SF-36) and the Minnesota Living with Heart Failure Questionnaire (MLHF-Q).
Training consisted of aerobic exercise at 70 percent of max. capacity estimated by Borg-scale.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Hvidovre
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Copenhagen, Hvidovre, 덴마크, 2650
- Hvidovre Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Adult subjects in permanent atrial fibrillation, willing to participate in a 12 weeks training program and able to give informed consent to participation were eligible for the study.
Exclusion Criteria:
- Subjects with severe refractory hypertension
- previous heart valve surgery, moderate to severe COPD
- restrictive lung disease, moderate to severe asthma
- pregnant or lactating subjects
- patients with a very low life expectancy
- patients who were unable to exercise or comply with the study protocol
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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간섭 없음: No intervention
Observation only
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실험적: Exercise training group
Group exercise training, three times weekly high-intensity
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group based exercise training
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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cardiac output
기간: participants will be followed for the duration of the intervention, an average of 12 weeks
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participants will be followed for the duration of the intervention, an average of 12 weeks
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participants will be followed for the duration of the intervention, an average of 12 weeks
|
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Quality of life
기간: participants will be followed for the duration of the intervention, an average of 12 weeks
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participants will be followed for the duration of the intervention, an average of 12 weeks
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participants will be followed for the duration of the intervention, an average of 12 weeks
|
|
exercise capacity
기간: participants will be followed for the duration of the intervention, an average of 12 weeks
|
participants will be followed for the duration of the intervention, an average of 12 weeks
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participants will be followed for the duration of the intervention, an average of 12 weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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muscle strength
기간: participants will be followed for the duration of the intervention, an average of 12 weeks
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participants will be followed for the duration of the intervention, an average of 12 weeks
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participants will be followed for the duration of the intervention, an average of 12 weeks
|
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biomarkers ANB, BNP
기간: participants will be followed for the duration of the intervention, an average of 12 weeks
|
participants will be followed for the duration of the intervention, an average of 12 weeks
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participants will be followed for the duration of the intervention, an average of 12 weeks
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Body composition DEXA-scan
기간: participants will be followed for the duration of the intervention, an average of 12 weeks
|
participants will be followed for the duration of the intervention, an average of 12 weeks
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participants will be followed for the duration of the intervention, an average of 12 weeks
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Philip S Osbak, MD, Hvidovre University Hospital
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 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. .
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