Prospective Aerobic Reconditioning Intervention Study (PARIS)
2019년 2월 12일 업데이트: Wake Forest University
Exercise Conditioning in Elderly Patients With Heart Failure
The purpose of this study is :
- To determine if aerobic exercise conditioning can improve symptoms, cardiovascular function and quality of life in elderly patients with congestive heart failure.
- To describe the baseline clinical characteristics, cardiovascular function and neurohumoral function in elderly patients with congestive heart failure.
- To determine the specific cardiovascular and noncardiovascular mechanisms by which symptoms and quality of life may improve following exercise conditioning in elderly patients with congestive heart failure.
연구 개요
상세 설명
In patients over age 65, cardiovascular disease accounts for the largest percentage of deaths, hospital days, doctor visits, and overall health care expenditures. In addition, heart failure is the most common discharge diagnosis in the elderly. Heart failure can be defined as a state in which cardiac output is insufficient to meet metabolic demands. This is most frequently manifested by symptoms of fatigue and dyspnea. Inherent in this definition is that symptoms may be increased or only occur during times when metabolic demand is increased, such as during exercise. As such, exercise intolerance is a hallmark of the heart failure syndrome. Exercise intolerance correlates not only with disease severity and also with subsequent mortality. Exercise tolerance can be objectively quantified during maximal symptom limited standardized exercise protocols by analysis of exercise time, workload, METS (metabolic equivalents), and oxygen consumption (V02)' These measures have appropriately become accepted as standards for functional assessment in this disorder as well as outcome measures following therapeutic interventions in HF. P.A.R.I.S. is a randomized, attention-controlled, single-blind trial of supervised aerobic exercise training in older patients with heart failure. The primary outcome is exercise capacity and the main secondary outcome is quality of life. Mechanistic outcomes were also examined. In PARIS, which focused on cardiac mechanisms, there were HFPEF and HFREF patients studied in parallel. In PARIS-II, there were only HFPEF patients which focused on vascular mechanisms.
Main outcomes have been reported (see citations below).
연구 유형
중재적
등록 (실제)
201
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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North Carolina
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Winston-Salem, North Carolina, 미국, 27157
- Wake Forest Baptist Health
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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
60년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Age greater than or equal to 60 years of age
- Symptoms of congestive heart failure
- Able to understand and give informed consent
Exclusion Criteria:
- Age <60 years
- Does not have CHF
- Significant change in cardiac medication <3 weeks
- Myocardial infarction <3 weeks
- CABG surgery <3 months
- Angina pectoris not controlled during daily activity by pharmacological therapy or at <4 METS activity
- Sustained hypertension with systolic> 190 and diastolic> 110 on medications
- Valvular heart disease as the primary etiology of CHF
- Significant aortic stenosis
- Stroke of <3 months or with any physical restriction impairment that would prevent participation in exercise programs
- Chronic obstructive pulmonary disease on therapy that limits exercise duration
- Uncontrolled diabetes mellitus
- Active treatment for cancer or other noncardiovascular conditions with life expectancy less than three years
- Anemia "10 gms Hb)
- Renal insufficiency (cr >2.5 mg/dl)
- Psychiatric disease - uncontrolled major psychoses, depressions, dementia, or personality disorder
- Dementia - MMSE ~24 "22 for ~8th grade education)
- Lack of an acoustic window sufficient to allow definition of endocardial borders on the screening echocardiogram.
- Plans to leave area or be admitted to a nursing home within 2 years.
- Inability to walk at least 420 feet in 6 minutes without a cane or other assistive device.
- Inability to exercise at or near home.
- At the discretion of the clinical staff, it is believed that the participant cannot or will not complete the protocol because of frailty, illness, or other reason.
- Participation in a regular exercise regimen more than one time per week for at least twenty minutes per session; including but not limited to walking, swimming, weight lifting, golfing, or taking an exercise class.
- Inability to ambulate without cane or other assistive device during biomechanics testing or treadmill.
- Inability to attend at least fourteen weeks of the facility-based intervention
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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위약 비교기: Control
Control group continues with their daily activity as they were prior to randomization.
Receive bi-weekly follow-up phone calls to assess health status and encourage adherence with protocol.
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Control group continues daily life as prior to randomization.
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활성 비교기: Exercise
Exercise classes three times per week in a controlled, supervised environment.
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Exercise classes three times per week in a controlled, supervised environment.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Peak exercise capacity
기간: 16 weeks
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16 weeks
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2차 결과 측정
결과 측정 |
기간 |
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삶의 질
기간: 16주
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16주
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
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
- Kitzman DW, Little WC, Brubaker PH, Anderson RT, Hundley WG, Marburger CT, Brosnihan B, Morgan TM, Stewart KP. Pathophysiological characterization of isolated diastolic heart failure in comparison to systolic heart failure. JAMA. 2002 Nov 6;288(17):2144-50. doi: 10.1001/jama.288.17.2144.
- Kitzman DW, Brubaker PH, Morgan TM, Stewart KP, Little WC. Exercise training in older patients with heart failure and preserved ejection fraction: a randomized, controlled, single-blind trial. Circ Heart Fail. 2010 Nov;3(6):659-67. doi: 10.1161/CIRCHEARTFAILURE.110.958785. Epub 2010 Sep 17.
- Brubaker PH, Moore JB, Stewart KP, Wesley DJ, Kitzman DW. Endurance exercise training in older patients with heart failure: results from a randomized, controlled, single-blind trial. J Am Geriatr Soc. 2009 Nov;57(11):1982-9. doi: 10.1111/j.1532-5415.2009.02499.x.
- John JM, Haykowsky M, Brubaker P, Stewart K, Kitzman DW. Decreased left ventricular distensibility in response to postural change in older patients with heart failure and preserved ejection fraction. Am J Physiol Heart Circ Physiol. 2010 Sep;299(3):H883-9. doi: 10.1152/ajpheart.00332.2010. Epub 2010 Jun 18.
- Haykowsky MJ, Brubaker PH, John JM, Stewart KP, Morgan TM, Kitzman DW. Determinants of exercise intolerance in elderly heart failure patients with preserved ejection fraction. J Am Coll Cardiol. 2011 Jul 12;58(3):265-74. doi: 10.1016/j.jacc.2011.02.055.
- Haykowsky MJ, Brubaker PH, Stewart KP, Morgan TM, Eggebeen J, Kitzman DW. Effect of endurance training on the determinants of peak exercise oxygen consumption in elderly patients with stable compensated heart failure and preserved ejection fraction. J Am Coll Cardiol. 2012 Jul 10;60(2):120-8. doi: 10.1016/j.jacc.2012.02.055.
- Moore B, Brubaker PH, Stewart KP, Kitzman DW. VE/VCO2 slope in older heart failure patients with normal versus reduced ejection fraction compared with age-matched healthy controls. J Card Fail. 2007 May;13(4):259-62. doi: 10.1016/j.cardfail.2006.12.005.
- Maldonado-Martin S, Brubaker PH, Kaminsky LA, Moore JB, Stewart KP, Kitzman DW. The relationship of a 6-min walk to VO(2 peak) and VT in older heart failure patients. Med Sci Sports Exerc. 2006 Jun;38(6):1047-53. doi: 10.1249/01.mss.0000222830.41735.14.
- Brubaker PH, Joo KC, Stewart KP, Fray B, Moore B, Kitzman DW. Chronotropic incompetence and its contribution to exercise intolerance in older heart failure patients. J Cardiopulm Rehabil. 2006 Mar-Apr;26(2):86-9. doi: 10.1097/00008483-200603000-00007. No abstract available.
- Brubaker PH, Marburger CT, Morgan TM, Fray B, Kitzman DW. Exercise responses of elderly patients with diastolic versus systolic heart failure. Med Sci Sports Exerc. 2003 Sep;35(9):1477-85. doi: 10.1249/01.MSS.0000084416.71232.EA.
- Marburger CT, Brubaker PH, Pollock WE, Morgan TM, Kitzman DW. Reproducibility of cardiopulmonary exercise testing in elderly patients with congestive heart failure. Am J Cardiol. 1998 Oct 1;82(7):905-9. doi: 10.1016/s0002-9149(98)00502-5.
- Kitzman DW, Brubaker PH, Herrington DM, Morgan TM, Stewart KP, Hundley WG, Abdelhamed A, Haykowsky MJ. Effect of endurance exercise training on endothelial function and arterial stiffness in older patients with heart failure and preserved ejection fraction: a randomized, controlled, single-blind trial. J Am Coll Cardiol. 2013 Aug 13;62(7):584-92. doi: 10.1016/j.jacc.2013.04.033. Epub 2013 May 9.
- Haykowsky MJ, Herrington DM, Brubaker PH, Morgan TM, Hundley WG, Kitzman DW. Relationship of flow-mediated arterial dilation and exercise capacity in older patients with heart failure and preserved ejection fraction. J Gerontol A Biol Sci Med Sci. 2013 Feb;68(2):161-7. doi: 10.1093/gerona/gls099. Epub 2012 Apr 20.
- Kitzman DW, Herrington DM, Brubaker PH, Moore JB, Eggebeen J, Haykowsky MJ. Carotid arterial stiffness and its relationship to exercise intolerance in older patients with heart failure and preserved ejection fraction. Hypertension. 2013 Jan;61(1):112-9. doi: 10.1161/HYPERTENSIONAHA.111.00163. Epub 2012 Nov 12.
- Haykowsky MJ, Kouba EJ, Brubaker PH, Nicklas BJ, Eggebeen J, Kitzman DW. Skeletal muscle composition and its relation to exercise intolerance in older patients with heart failure and preserved ejection fraction. Am J Cardiol. 2014 Apr 1;113(7):1211-6. doi: 10.1016/j.amjcard.2013.12.031. Epub 2014 Jan 15.
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
1993년 7월 1일
기본 완료 (실제)
2004년 12월 1일
연구 완료 (실제)
2009년 12월 1일
연구 등록 날짜
최초 제출
2010년 4월 29일
QC 기준을 충족하는 최초 제출
2010년 4월 29일
처음 게시됨 (추정)
2010년 4월 30일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 2월 15일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 2월 12일
마지막으로 확인됨
2019년 2월 1일
추가 정보
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