The Effect of Yoga on Cardiac Sympathetic Innervation Evaluated by I-123 mIBG
2018년 3월 18일 업데이트: Mehran Attari, University of Cincinnati
The purpose of this study is to evaluate if yoga practice will reduce cardiac sympathetic activity and subsequently cardiac arrhythmias.
연구 개요
상세 설명
Subjects with reduced ejection fraction will be randomized to 8 weeks Yoga training (1 in class session and home practice) vs. no Yoga.
They will undergo holter monitoring, cardiac device interrogation, and I-123 mIBG imaging at the beginning and end of the study.
연구 유형
중재적
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Ohio
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Cincinnati, Ohio, 미국, 45219
- University of Cincinnati Medical Center
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Negative pregnancy test in females
- Ejection Fraction </= 40% assessed by echocardiogram within the last 12 months
- Stable dose of heart failure medications including afterload reducing medication such as ACE-I, ARB and hydralazine; beta blockers; digoxin and aldosterone antagonist for at least 4 months and no anticipated changes for 8 weeks. (i.e. no greater than a 50% dose change within the past month)
- Has an implantable pacemaker or ICD
- NYHA II-IV
Exclusion Criteria:
- pregnant or lactating female
- females without a pregnancy test
- co-administration of a positive inotrope (i.e. milrinone or dobutamine)
- history of significant medical non-compliance
- unwilling to adhere to the protocol
- Orthopedic limitation making yoga participation difficult
- Underlying cardiac rhythm other than sinus rhythm
- Recent history within 6 months prior to enrollment of unstable coronary artery disease (unstable angina, recent heart attack, recent revascularization, or decompensated heart failure)
- implantation of a cardiac resynchronization therapy device in the past 3 months.
- TIA, CVA, or major surgery in the past 3 months
- iodine or adreview (123-MIBG) allergy
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: No yoga training
This will be the control arm.
The patients in this arm will not receive any yoga training.
They will be continued on all their home, guideline-directed heart failure medications.
They will undergo the same baseline and study completion evaluation as the treatment arm, including an I-123 MIBG scan, 24-hour holter monitoring and device interrogation.
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실험적: Yoga training
The patients in this arm will receive yoga training.
This includes weekly group yoga sessions consisting of breathing exercises, yoga poses, and relaxation and meditation lasting for about 80-90 minutes total.
Patients will be asked to do home yoga practices at least twice a week and to document the date and time.
Patients in this arm will have the same baseline and study completion evaluation as the control arm, including an I-123 MIBG scan, 24-hour holter monitoring and device interrogation.
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Subjects will complete in class yoga training weekly for 8 weeks with additional practice at home
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Cardiac sympathetic activity following yoga training
기간: 8 weeks
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A comparison of of the I-123 MIBG heart to mediastinal uptake ratio at baseline and completion of the yoga training.
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8 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Relationship between I-123MIBG heart-to-mediastinal ratios and the total atrial and ventricular arrhythmia burden.
기간: 8 weeks
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Association between heart to mediastinum ration and ventricular arrhythmia burden
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8 weeks
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Mehran Attari, University of Cincinnati
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
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연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2017년 9월 30일
기본 완료 (실제)
2017년 10월 27일
연구 완료 (실제)
2017년 10월 27일
연구 등록 날짜
최초 제출
2017년 7월 20일
QC 기준을 충족하는 최초 제출
2017년 7월 20일
처음 게시됨 (실제)
2017년 7월 24일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 3월 20일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 3월 18일
마지막으로 확인됨
2018년 3월 1일
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. .
심부전, 수축기에 대한 임상 시험
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Fondation Hôpital Saint-Joseph모병
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Medical University of BialystokMedical University of Lodz; Poznan University of Medical Sciences; Nicolaus Copernicus University 그리고 다른 협력자들종료됨심부전, 수축기 | 박출률이 감소된 심부전 | 심부전 New York Heart Association Class IV | 심부전 New York Heart Association Class III폴란드
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Novartis Pharmaceuticals완전한핵심 연구의 12개월 치료 기간을 성공적으로 완료한 환자(de Novo Heart Recipients)는 EC-MPS 치료에 관심이 있었습니다.
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University of WashingtonAmerican Heart Association완전한심부전，울혈 | 미토콘드리아 변경 | 심부전 New York Heart Association Class IV미국
Yoga training에 대한 임상 시험
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Istanbul University모집하지 않고 적극적으로
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King's College LondonUniversity College, London; Brighton & Sussex Medical School완전한
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Oslo University HospitalAkershus University Hospital, Lørenskog, Norway; Koc University Hospital, Istanbul, Turkey 그리고 다른 협력자들완전한우울증 | 스트레스 | 불명증 | 불안 | 낙천주의 | 대인 관계 이탈 | 전문적인 이행 | 일의 피로 | 자가 보고 의료 오류 | 의사 소진칠면조
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MMSx Authority Institute for Movement Mechanics...완전한