Transitional Rehabilitation in CABG Patients
2021年7月10日 更新者：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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
54
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Vermont
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Burlington、Vermont、美国、05405
- University of Vermont College of Medicine
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
50年 至 80年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预：控制
无治疗对照
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实验性的：Treatment
Neuromuscular electrical stimulation
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bilateral quadriceps exercise with neuromuscular electrical stimulation
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Short Physical Performance Battery
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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6 Minute Walk Distance
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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 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
大体时间：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 focused on vitality (energy and fatigue).
Lower scores represent less vitality, while higher scores represent more vitality.
|
Hospital discharge and 4-weeks post-discharge
|
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Medical Outcomes Short Form 36 - Social Function
大体时间：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
大体时间：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
大体时间：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
大体时间：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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年9月1日
初级完成 (实际的)
2019年10月24日
研究完成 (实际的)
2019年10月24日
研究注册日期
首次提交
2019年3月26日
首先提交符合 QC 标准的
2019年3月26日
首次发布 (实际的)
2019年3月27日
研究记录更新
最后更新发布 (实际的)
2021年8月3日
上次提交的符合 QC 标准的更新
2021年7月10日
最后验证
2021年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
neuromuscular electrical stimulation的临床试验
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Mayo ClinicNational Institute of Mental Health (NIMH)招聘中
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RS MedicalAccelerated Care Plus; Research Institute of Health and Science (RIHSE)完全的