The Effect of Exercise Training on Skeletal Muscle Metabolism in Peripheral Artery Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Expression of genes regulating skeletal muscle metabolism
研究概览
简要总结
Specific Aim 1: To test the hypothesis that subjects with PAD and intermittent claudication have altered expression of genes that regulate skeletal muscle metabolism.
Specific Aim 2: To test the hypothesis that exercise training improves calf skeletal muscle insulin resistance and genes that regulate skeletal muscle metabolic function in PAD patients with intermittent claudication.
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
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •claudication symptoms
- •ABI ≤ 0.9 in the symptomatic leg
排除标准
- •impaired fasting glucose
- •peripheral vascular intervention within the prior six months
- •recent unstable angina
- •myocardial infarction or stroke within the prior six months
- •changes to their HMG-CoA reductase inhibitor (statin)within the past three months
- •changes to pentoxifylline and/or cilostazol regimen within the past three months or anticipated to be necessary during the study
- •are on Coumadin
- •exercise limitations for reasons other than intermittent claudication (such as congestive heart failure, angina, chronic lung disease, or other disorders affecting the limb such as arthritis or neuropathy)
- •rest pain or ulcers due to critical limb ischemia
- •lower extremity amputation
研究组 & 干预措施
Exercise Training
Subjects randomized to exercise training will participate in a three-month treadmill exercise program in 1-hour training sessions three times per week as previously described. After a 5-minute warm-up period, exercise is initiated at a low workload of 2 mph at 0% grade. Subjects walk until moderate claudication severity develops, and then rest until the discomfort resolves, repeating until the total exercise period is completed. The intensity of the treadmill exercise is increased as tolerated by increasing walking speed by 0.5-1 mph and/or grade by 1-2%. Subjects are encouraged to continue the walking program at home for at least 30 minutes on two separate occasions each week.
干预措施: Exercise Training (Other)
Normal routine
Subjects randomized to the routine activity control group will be asked to keep a log of their daily activities and return to the Vascular Research Center at weeks 4, 8, and 12 at which time they will be asked to return their log and undergo repeat treadmill testing and complete the 6 minute walk test.
干预措施: Normal routine (Other)
结局指标
主要结局
Expression of genes regulating skeletal muscle metabolism
时间窗: 3 months
次要结局
- Additional measures include skeletal muscle glucose uptake, measures of functional capacity, leg blood flow, and quality of life.(3 months)
研究者
Reena Pande, MD
Instructor, Harvard Medical School
Brigham and Women's Hospital