- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00094250
HEARTS: Heart, Exercise, and Resistance Training Study
More Effective Exercise Modalities in Older Congestive Heart Failure Patients
연구 개요
상세 설명
BACKGROUND:
The amount of functional skeletal muscle that CHF patients are able to preserve is a major independent predictor of their ability to maintain physical function. Older patients with CHF (who make up the vast majority of CHF patients) are least able to do this. The disease is marked by a loss of aerobic muscle fibers, while aging is marked by a loss of glycolytic muscle fibers. Because the disease may be physiologically different in older CHF patients than in younger ones (due to loss of both muscle types in older CHF patients), they need different therapeutic approaches. Strategy tests aimed at increasing muscle mass through resistance strength training in systolic failure patients have been rare, small, and generally lacking older participants. The studies done among younger CHF patients have shown that both aerobic, and combination aerobic and strength training can increase work capacity, oxidative muscle activity, and glycolytic muscle strength. Additionally, combination training can improve cardiac measures, including LVEF.
DESIGN NARRATIVE:
An estimated 200 participants age 65 and older with Class II and III CHF and LVEF 20% to 40% will be included in this study. Their work capacity will be measured in watts on a cycle ergometer exercise stress test (Time 1). They will be randomized by gender, race, and disease severity into two exercise groups: 1) resistance and aerobic training (RA); and 2) aerobic training (A). Both groups will exercise three times a week for 4 months. At the end of the 4 months of training, the cycle ergometer stress test will be repeated (Time 2). By comparing changes in maximum watts achieved from Time 1 to Time 2 in each group, an assessment can be made of the effectiveness of each exercise program in improving work capacity. Secondarily, measures will be performed and compared of myocardial remodeling, leg strength, and leg muscle oxidative capacity at Time 1 and Time 2. The goal of the study is to determine the following:
- If low resistance frequent repetition resistance training combined with aerobic training increases aerobic work capacity more than pure aerobic training.
- If any improvement in aerobic work capacity is due to changes in muscle fiber composition, local blood flow, arterial endothelial function, or some combination.
The study completion date listed in this record was obtained from the "Completed Date" entered in the Query View Report System (QVR).
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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New York
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Staten Island, New York, 미국
- Staten Island University Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Class II and III CHF that has been clinically stable for at least 6 months
- Systolic ejection fraction (LVEF) between 20% and 40%
- Under the care of a cardiologist who is willing to have the patient participate in the study and who will continue to follow the patient medically during his/her participation
- Willing and able to undergo the screening procedures and the 1 month observation period to determine eligibility
- Willing and able to come to the research center three times a week for 4 months to participate in an exercise program consisting of either aerobic exercise only, or aerobic exercise plus resistance training
- Able to speak and read English
- Willing to participate in the study after having the study explained to him/her and has signed an informed consent form
Exclusion Criteria:
- Eligible for a cardiac rehabilitation program under Medicare rules due to a recent acute event
- Any medical condition that would make either exercise unsafe or uncomfortable, such as symptomatic COPD, severe arthritis, severe peripheral vascular disease, unstable heart disease, uncontrolled blood pressure, or neurological conditions
- Other complicating diseases, such as severe anemia or other blood dyscrasia affecting function, chronic renal failure, progressive cancer, or unstable diabetes
- Does not otherwise meet the above inclusion criteria
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 할당: 무작위
- 중재 모델: 병렬 할당
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
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Improvement in work capacity at anaerobic threshold (measured at Month 4)
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2차 결과 측정
결과 측정 |
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Improvements in muscle oxidative capacity, as measured by near infrared spectroscopy (NIRS)
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Improvements in local muscle blood flow by NIRS and plethysmography
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Improvement in arterial endothelial function (all measured at Month 4)
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공동 작업자 및 조사자
수사관
- 수석 연구원: Joel Posner, MD, Chairman of Medicine, Staten Island University Hospital
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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