- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01919918
Muscle Afferent Feedback Effects in Patients With Heart Failure
Muscle Afferent Feedback Effects in Patients With Heart Failure: The Development of Central Fatigue
연구 개요
상세 설명
A substantial part in limiting exercise and/or physical activity in humans results from the development of peripheral and central fatigue during physical activity. Peripheral fatigue comprises biochemical changes within the metabolic milieu of the working muscle leading to an attenuated response to neural excitation, while central fatigue comprises a failure of the central nervous system to drive motoneurons.
Patients with HF have overactive group III/IV muscle afferents and an exaggerated development of central fatigue during physical activity that is not explained by their reduced physical conditioning or cardiac insufficiency caused by their failing heart. The exact mechanisms accounting for the exaggerated central fatigue in HF remains elusive, however, the development of central fatigue during exercise has recently been linked to signaling by group III/IV muscle afferents. This makes the heightened neural feedback in HF a likely candidate for these patients' increased susceptibility to central fatigue.
Lower pH, increased lactate and increased adenosine triphosphate has been shown to activate group III/IV afferents in a physiological manner and thus induce, in a rested and unfatigued muscle, the intramuscular milieu associated with moderate to heavy exercise. The objective of this study is to quantitate and compare the sensitivity of group III/IV afferents and associated effects on central fatigue in HF patients and healthy controls when skeletal muscle is subject to controlled lower pH, increased lactate and increased adenosine triphosphate.
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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Utah
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Salt Lake City, Utah, 미국, 84148
- Veterans Affairs Salt Lake City Heath Care System
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Salt Lake City, Utah, 미국, 84148
- George E Wahlen Vetern Affairs Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Heart Failure Inclusion Criteria:
- Subjects with a history of stable cardiomyopathy (ischemic and non-ischemic, greater than 1 year duration, ages 20-79 years)
- New York Heart Association class I through IV symptoms
- Left ventricular ejection fraction less than 35 percent (heart failure patients with reduced left ventricular ejection fraction) or greater than 50 percent (heart failure patients with preserved left ventricular ejection fraction)
- Sedentary, no regular physical activity for at least 6 months prior
- Post-menopausal for at least 2 years and follicle stimulating hormone greater than 40
Heart Failure Exclusion Criteria:
- Patients with atrial fibrillation or heart failure believed to be secondary to atrial fibrillation
- Morbidly obese patients with a body mass index greater than 35
- Patients with uncontrolled hypertension, greater than 160/100
- Anemia with a hemoglobin less than 9
- Severe renal insufficiency (creatinine clearance less than 30 by the Cockcroft-Gault formula)
- Patients with significant non-cardiac comorbidities
- Orthopedic limitations that would prohibit them from performing the elbow-flexor exercise
- Current smoker or smoking history of 15 packs or more per year
- Women currently taking hormone replacement therapy
Healthy Control Inclusion Criteria:
- Ages 20-75 years
- Sedentary, no regular physical activity for at least 6 months prior
- Post-menopausal for at least 2 years and follicle stimulating hormone greater than 40
Healthy Control Exclusion Criteria:
- History of cardiovascular related abnormalities or pulmonary abnormalities
- Morbidly obese patients with a body mass index greater than 35
- Patients with uncontrolled hypertension, greater than 160/100
- Anemia with a hemoglobin less than 9
- Orthopedic limitations that would prohibit them from performing the elbow-flexor exercise
- Current smoker or smoking history of 15 packs or more per year
- Women currently taking hormone replacement therapy
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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다른: Heart Failure Patients
Patients with heart failure will undergo intervention of muscle contraction with metabolite solution administration.
Maximal voluntary muscle contraction exercise with varying metabolite solution administration of adenosine triphosphate, lactate, and protons with phosphate buffer.
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Participants will perform maximal elbow flexor or knee extensor contractions before and after administration of metabolite solutions of pH 7.2, pH 7.0 and pH 6.6
다른 이름들:
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다른: Control Participants
Healthy control participants will undergo intervention of muscle contraction with metabolite solution administration.
Maximal voluntary muscle contraction exercise with varying metabolite solution administration of adenosine triphosphate, lactate, and protons with phosphate buffer.
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Participants will perform maximal elbow flexor or knee extensor contractions before and after administration of metabolite solutions of pH 7.2, pH 7.0 and pH 6.6
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Elbow Flexor Maximal Voluntary Contraction in newton-meters
기간: 2 minutes
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2 minutes
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공동 작업자 및 조사자
수사관
- 수석 연구원: Markus Amann, PhD, University of Utah
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 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 62914
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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