Transitional Rehabilitation in CABG Patients
2021년 7월 10일 업데이트: Michael J. Toth, Ph.D., University of Vermont
Novel Transitional Rehabilitation Care in Coronary Artery Bypass Graft (CABG) Patients
The goal of this research study is to understand whether an at-home exercise program started soon after CABG surgery, and continuing for 4 weeks following discharge from the hospital, can preserve or improve physical function.
연구 개요
상세 설명
Coronary artery bypass graft (CABG) surgery is a common surgical procedures and an important treatment option for coronary artery disease.
The post-surgery period of rest and recovery is associated with cardiorespiratory and skeletal muscle deconditioning.
The goal of this research study is to understand whether an at-home exercise program started soon after CABG surgery, and continuing for 4 weeks following discharge from the hospital, can serve as a bridge between surgery and the start of cardiac rehabilitation to preserve or improve physical function.
Volunteers will be randomly assigned to receive neuromuscular electrical stimulation (NMES) of their quadriceps muscles or not to receive NMES (control group).
Volunteers will be evaluated prior to CABG, upon discharge and 4 weeks Post-CABG surgery.
Assessments will include measurements of physical function by the Short Physical Performance Battery, 6 min walk tests and body composition analysis, as well as assessment of subjective physical functional capacity and quality of life using the Medical Outcomes Short form 36. Additionally, accelerometry will be used to monitor weight-bearing physical activity during the 4 week treatment phase.
연구 유형
중재적
등록 (실제)
54
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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Vermont
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Burlington, Vermont, 미국, 05405
- University of Vermont College of Medicine
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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
50년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- 50-80 yrs of age
- ambulatory
- scheduled for coronary artery bypass graft surgery
- able to provide informed consent
Exclusion Criteria:
- rheumatoid arthritis or other inflammatory/autoimmune disease
- cancer, excluding non-melanoma skin cancer
- exercise limiting peripheral vascular disease
- neuromuscular disease or neuromuscular dysfunction associated with cerebrovascular event
- body mass index >38 kg/m2
- valvular heart disease not corrected surgically
- lower extremity blood clot or implantable cardioverter-defibrillator
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: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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간섭 없음: 제어
처리 제어 없음
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실험적: Treatment
Neuromuscular electrical stimulation
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bilateral quadriceps exercise with neuromuscular electrical stimulation
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Short Physical Performance Battery
기간: 4 weeks
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Short Physical Performance Battery is composed of three tasks assessing balance, gait speed, and ability to stand from a chair.
Units on a scale for each domain range from of 0-4 for a total score of 0 to 12, with a higher score indicating better physical function.
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4 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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6 Minute Walk Distance
기간: 4 weeks
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6 MW was developed to assess cardiopulmonary fitness in patients with lung and cardiac disease, and has been validated in cardiac surgery patients.
It assesses the distance that a patient can walk in 6 minutes time around a standard course.
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4 weeks
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Medical Outcomes Short Form 36 - Physical Function
기간: Hospital discharge and 4-weeks post-discharge
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The Medical Outcomes Short Form 36 is a questionnaire that assesses self-reported health and physical functional status.
There are 36 questions that reflect eight sub-domains of health included in this questionnaire.
Scores for each domain represent weighted sums of the questions in each sub-domain.
Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.
This sub-domain focused on limitations in physical function due to health problems.
Lower scores represent more physical function disability, while higher scores represent less disability.
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Hospital discharge and 4-weeks post-discharge
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Medical Outcome Short Form 36 - Role Physical
기간: Hospital discharge and 4-weeks post-discharge
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The Medical Outcomes Short Form 36 is a questionnaire that assesses self-reported health and physical functional status.
There are 36 questions that reflect eight sub-domains of health included in this questionnaire.
Scores for each domain represent weighted sums of the questions in each sub-domain.
Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.
This sub-domain focused on limitations in usual role activities because of physical health problems.
Lower scores represent more disability, while higher scores represent less disability.
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Hospital discharge and 4-weeks post-discharge
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Medical Outcomes Short Form 36 - Bodily Pain
기간: Hospital discharge and 4-week post-discharge
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The Medical Outcomes Short Form 36 is a questionnaire that assesses self-reported health and physical functional status.
There are 36 questions that reflect eight sub-domains of health included in this questionnaire.
Scores for each domain represent weighted sums of the questions in each sub-domain.
Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.
This sub-domain focused on bodily pain.
Lower scores represent more pain, while higher scores represent less pain.
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Hospital discharge and 4-week post-discharge
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Medical Outcomes Short Form 36 - General Health
기간: Hospital discharge and 4-week post-discharge
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The Medical Outcomes Short Form 36 is a questionnaire that assesses self-reported health and physical functional status.
There are 36 questions that reflect eight sub-domains of health included in this questionnaire.
Scores for each domain represent weighted sums of the questions in each sub-domain.
Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.
This sub-domain focused on self-reported general health.
Lower scores represent worse health, while higher scores represent better health.
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Hospital discharge and 4-week post-discharge
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Medical Outcomes Short Form 36 - Vitality
기간: Hospital discharge and 4-weeks post-discharge
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The Medical Outcomes Short Form 36 is a questionnaire that assesses self-reported health and physical functional status.
There are 36 questions that reflect eight sub-domains of health included in this questionnaire.
Scores for each domain represent weighted sums of the questions in each sub-domain.
Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.
This sub-domain focused on vitality (energy and fatigue).
Lower scores represent less vitality, while higher scores represent more vitality.
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Hospital discharge and 4-weeks post-discharge
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Medical Outcomes Short Form 36 - Social Function
기간: Hospital discharge and 4-weeks post-discharge
|
The Medical Outcomes Short Form 36 is a questionnaire that assesses self-reported health and physical functional status.
There are 36 questions that reflect eight sub-domains of health included in this questionnaire.
Scores for each domain represent weighted sums of the questions in each sub-domain.
Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.
This sub-domain focuses on limitations in social activities because of physical or emotional problems.
Lower scores represent more more limitations, while higher scores represent less lmitations.
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Hospital discharge and 4-weeks post-discharge
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Medical Outcomes Short Form 36 - Role Emotional
기간: Hospital discharge and 4-week discharge
|
The Medical Outcomes Short Form 36 is a questionnaire that assesses self-reported health and physical functional status.
There are 36 questions that reflect eight sub-domains of health included in this questionnaire.
Scores for each domain represent weighted sums of the questions in each sub-domain.
Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.
This sub-domain focuses on limitations in usual role activities because of emotional problems.
Lower scores represent more limitations, while higher scores represent less limitations.
|
Hospital discharge and 4-week discharge
|
|
Medical Outcomes Short Form 36
기간: Hospital discharge and 4-week post-discharge
|
The Medical Outcomes Short Form 36 is a questionnaire that assesses self-reported health and physical functional status.
There are 36 questions that reflect eight sub-domains of health included in this questionnaire.
Scores for each domain represent weighted sums of the questions in each sub-domain.
Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.
This measure represents the total computed score across all sub-domains.
Lower scores represent worse overall health, while higher scores represent better health.
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Hospital discharge and 4-week post-discharge
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Physical Activity
기간: Daily from discharge to 4-week post-discharge evaluation
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Physical activity was measured throughout the intervention in control and treatment groups and data.
Data were analyzed by regression analysis to obtain the best fit line for the data and to compute a slope of the change in step count with day post-discharge to examine whether groups differed in their rate of recovery of weight-bearing activity (ie, walking).
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Daily from discharge to 4-week post-discharge evaluation
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간행물 및 유용한 링크
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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 1일
기본 완료 (실제)
2019년 10월 24일
연구 완료 (실제)
2019년 10월 24일
연구 등록 날짜
최초 제출
2019년 3월 26일
QC 기준을 충족하는 최초 제출
2019년 3월 26일
처음 게시됨 (실제)
2019년 3월 27일
연구 기록 업데이트
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2021년 8월 3일
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2021년 7월 10일
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2021년 7월 1일
추가 정보
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