The Impact of Training With Whole Body-EMS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Mean Change in Reactive Hyperemia Index (RHI)
研究概览
简要总结
Researchers are trying to find out what impact training with whole body-EMS (Electronic muscle stimulation) has on various health outcomes.
详细描述
All subjects in both groups who enroll into this study will undergo an assessment of peripheral endothelial function with reactive hyperemia-peripheral arterial tonometry (RH-PAT) testing using EndoPAT; an assessment of vital signs including heart rate, blood pressure, weight, height and body mass index; laboratory blood work; cardiorespiratory testing using treadmill testing to determine VO2 max and maximal tolerated heart rate; maximal strength and maximal power testing on chest press and leg press testing; and percent body fat and fat distribution testing at baseline, and at 16-weeks follow-up (immediately after completing a 16-week training program using whole body-EMS). Baseline cardiovascular risk factors will be assessed by subject questionnaire and verified by chart review. In addition, subjects will complete an angina/chest pain symptom questionnaire (Rose Questionnaire), quality of life questionnaire (LASA Questionnaire), depression questionnaire (Patient Health Questionaire-9) and perceived stress questionnaire (Perceived Stress Scale) to assess for psychosocial wellness at each point in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy individuals
- •Employees at the Mayo Clinic, Rochester, MN
排除标准
- •Subjects under the age of 18
- •Pregnant women
- •Subjects with a history of liver or kidney disease, acute illness, taking medications (such as glucocorticoids)
- •Subjects who have conditions (such as chronic inflammatory muscular diseases or Cushing's syndrome) that affect muscle mass
- •Individuals with pacemakers and implantable cardiac defibrillators
- •Individuals who conduct any other type of resistance training (> 45 minutes/week)
- •Individuals who have regular "high" alcohol consumption (> 80g/day on 5 days a week)
- •Subjects unable to consent to or participate in the 16-week EMS intervention or be available for follow up
结局指标
主要结局
Mean Change in Reactive Hyperemia Index (RHI)
时间窗: baseline, 16 weeks
Mean change in RHI. RHI measured by noninvasive endothelial peripheral arterial tomography (EndoPat) test. The EndoPAT involves probes on the index fingers of both hands \& evaluating the blood flow to one hand before \& after inflating a blood pressure (BP) cuff on one arm, temporarily reducing blood flow to the fingers. The finger sensor on the affected arm will show no blood flow, the sensor on the opposite index finger will display normal blood flow level. After several minutes, the BP cuff is released, allowing blood to flow back into the affected lower arm. If the finger sensor on the affected arm shows a rush of blood, the blood vessels are functioning normally. If the blood flow return is sluggish, the blood vessels are unhealthy. EndoPAT results are reported as the "Endoscore" (range 0-3); a score of 1.67 and lower indicates the need for immediate medical attention; a score between 1.68 and 2 indicates a need to reduce risk factors; a score above 2.1 indicates a healthy heart.
次要结局
- Change in Creatinine Kinase (CK)(baseline, 16 weeks)
- Change in BMI(baseline,16 weeks)
- Mean Change in Quality-of-Life Score as Measured by the Longitudinal Amsterdam Aging Study (LASA) Questionnaire:(baseline, week 16)
- Change in High Sensitivity C- Reactive Protein (CRP)(baseline, 16 weeks)
- Change in Lipoprotein(baseline, 16 weeks)
- Mean Change in Depression Score as Measured by the Patient Health Questionnaire (PHQ-9)(baseline, 16 weeks)
- Change in Blood Glucose(baseline, 16 weeks)
- Change in Homocysteine(baseline, 16 weeks)
- Mean Change in Stress Score as Measured by the Perceived Stress Scale(baseline, week 16)
- Change in HbA1c(baseline, 16 weeks)
- Change in Uric Acid:(baseline, 16 weeks)
- Change in Fibrinogen(Baseline, 16 weeks)
- Change in Total Cholesterol(baseline, 16 weeks)
- Change in Maximal Oxygen Consumption (VO2max)(baseline, 16 weeks)