Novel Transitional Rehabilitation Care in Coronary Artery Bypass Graft (CABG) Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Short Physical Performance Battery
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •50-80 yrs of age
- •ambulatory
- •scheduled for coronary artery bypass graft surgery
- •able to provide informed consent
排除标准
- •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
结局指标
主要结局
Short Physical Performance Battery
时间窗: 4 weeks
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.
次要结局
- Medical Outcomes Short Form 36 - Physical Function(Hospital discharge and 4-weeks post-discharge)
- Medical Outcomes Short Form 36 - Bodily Pain(Hospital discharge and 4-week post-discharge)
- 6 Minute Walk Distance(4 weeks)
- Medical Outcome Short Form 36 - Role Physical(Hospital discharge and 4-weeks post-discharge)
- Medical Outcomes Short Form 36 - Social Function(Hospital discharge and 4-weeks post-discharge)
- Medical Outcomes Short Form 36(Hospital discharge and 4-week post-discharge)
- Physical Activity(Daily from discharge to 4-week post-discharge evaluation)
- Medical Outcomes Short Form 36 - General Health(Hospital discharge and 4-week post-discharge)
- Medical Outcomes Short Form 36 - Vitality(Hospital discharge and 4-weeks post-discharge)
- Medical Outcomes Short Form 36 - Role Emotional(Hospital discharge and 4-week discharge)
研究者
Michael J. Toth, Ph.D.
Professor of Medicine
University of Vermont