Impact of CABG Surgery and Subsequent Exercise Intervention on Insulin Sensitivity and Muscle Mass: a Cluster Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- change in muscle mass and insulin sensitivity
研究概览
简要总结
In this study, the investigators want to examine the impact of coronary artery bypass graft (CABG) surgery on skeletal muscle mass, muscle metabolism, and insulin sensitivity in 90 subjects. In extent, the impact of a subsequent exercise intervention will be examined, with a follow-up up to 12 months after surgery.
详细描述
90 subjects undergoing elective CABG surgery will be included. These subjects are free from orthopedic limitations, will have no severe complications during surgery, and are willing to participate in a 12-week exercise training intervention.
At baseline (before surgery), following parameters will be assessed: blood parameters (glycemic control, lipid profile, anabolic/catabolic hormones, inflammatory markers), body composition (by dual x-ray absorptiometry), handgrip strength, and general subject features (medication, gender, age, etc.).
The first three days after surgery, blood samples will be collected for the analysis of glycemic control, lipid profile, anabolic/catabolic hormones, inflammatory markers.
Next, at the start of exercise intervention, after 6 and 12 weeks of exercise training, and after a 12-month follow-up, following parameters will be assessed: blood parameters (glycemic control, lipid profile, anabolic/catabolic hormones, inflammatory markers), body composition (by dual x-ray absorptiometry), handgrip strength, maximal exercise capacity (by ergospirometry testing), physical activity (by questionnaire), and quality of life ( by questionnaire).
At 12 months of follow-up, cardiovascular mortality and morbidity (re-occurrence of angina, acute myocardial infarction, need for surgery, death) will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective CABG surgery
- •Willing to participate in 12-week exercise intervention
排除标准
- •Complicated surgery
- •Severe complications during first days after CABG surgery
- •Orthopedic limitations that interfere with proper exercise intervention participation
结局指标
主要结局
change in muscle mass and insulin sensitivity
时间窗: pre-operative, 1, 2, 3 days, and 2, 12, 54 weeks after surgery
Baseline insulin sensitivity and muscle mass will be assessed ahead of surgery. Afterwards, the change in these parameters will be assessed at various predefined timepoints.
次要结局
- change in exercise capacity(2, 12, 54 weeks after surgery)
研究者
Dominique Hansen
Associate Professor
Hasselt University