Effects of Functional Electrical Stimulation in Patients Undergoing Coronary Artery Bypass Grafting Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Muscle thickness of the quadriceps femoris
研究概览
简要总结
Even with major advances in clinical therapy and percutaneous interventions, coronary artery bypass grafting (CABG) is the most common cardiac surgery performed worldwide and is an effective treatment in reducing symptoms and mortality in patients with coronary artery disease (CAD). However, CABG is a complex procedure that triggers a series of clinical and functional complications, such as series postoperative repercussions as muscle wasting in the first four hours after surgery. For quantification of changes in muscle structure and morphology ultrasonography has been used.
In this context, cardiac rehabilitation program (CRP) is an essential component of care in CABG patients, because this intervention can prevent muscle weakness and wasting. Among different treatment modalities, functional electrical stimulation (FES) is a feasible therapy for neuromuscular activation and prevent muscle weakness and wasting in patients in phase I CRP, however the effect of this intervention in phase II CRP not been fully elucidated. The purpose of this study will to assess the effects of FES plus combined aerobic and resistance training on muscle thickness of quadriceps femoris, lower limbs muscle strength, functional capacity, QoL in in CABG patients enrolled in a phase II CR program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing CABG up to three weeks before the initiation of the study, a clinical course without complications during hospitalization
- •Clinically stable
- •The absence of smoking (previous or current).
排除标准
- •Unstable angina
- •Myocardial infarction and heart surgery up to three months before the survey
- •Chronic respiratory diseases
- •Hemodynamic instability
- •Orthopedic and neurological diseases that may preclude the achievement of the cardiopulmonary test and Cardiac Rehabilitation exercises
- •Psychological and/or cognitive impairment that restrict them to respond to questionnaires
- •Changes of skin sensitivity,skin lesion and allergic skin problems
- •Severe lymphedema
- •Uncontrolled diabetes mellitus
- •Acute superficial venous thrombophlebitis
- •Systemic arterial hypertension
结局指标
主要结局
Muscle thickness of the quadriceps femoris
时间窗: Change in muscle thickness (in cm) from baseline at after 12 weeks of rehabilitation cardiac admission, an average of 3 months
Muscle thickness of the quadriceps femoris will be assessed by ultrasonography (baseline and after 12 weeks)
次要结局
- Ankle-brachial index(Change in ankle-brachial index (in mmHg) from baseline at after 12 weeks of rehabilitation cardiac admission, an average of 3 months)
- Vastus intermedius, rectus femoris echo intensity(Change in vastus intermedius and rectus femoris echo intensity (in region of interest -ROI) from baseline at after 12 weeks of rehabilitation cardiac admission, an average of 3 months)
- Rectus femoris cross-sectional area(Change in rectus femoris cross-sectional area (in cm2) from baseline at after 12 weeks of rehabilitation cardiac admission, an average of 3 months)
- Rectus femoris and vastus intermedius thickness(Change in rectus femoris and vastus intermedius thickness (in cm) from baseline at after 12 weeks of rehabilitation cardiac admission, an average of 3 months)
- Peripheral muscle strength of the lower limbs(Change in peripheral muscle strength (in the maximum load (kg) lifted up during the one-repetition maximum test ) from baseline at after 12 weeks of rehabilitation cardiac admission, an average of 3 months)
- Quality of life(Change in MacNew scores from baseline at after 12 weeks of rehabilitation cardiac admission, an average of 3 months)
- Lower-limb functional exercise capacity(Change in distance walked (meters) by the patients during six-minute walk test from baseline at after 12 weeks of rehabilitation cardiac admission, an average of 3 months)
研究者
Isabella Martins de Albuquerque
Professor DSc
Universidade Federal de Santa Maria