Impact of Enhanced External Counterpulsation (EECP) on VO2 MAX
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- VO2 MAX
研究概览
简要总结
The purpose of this study is to assess the effects of 35 EECP sessions on cardiopulmonary training performance in healthy volunteers. Data from this study will be used to generate sample size and power calculations for feasibility of future EECP studies. The results of this study could provide evidence that can help active duty and Department of Defense beneficiaries optimize physical conditioning, endurance and overall health.
详细描述
The purpose of this study is to assess the effects of 35 EECP sessions on cardiopulmonary training performance in healthy volunteers. Prior published and anecdotal evidence suggests that EECP should improve athletic performance. Data from this study will be used to generate sample size and power calculations for feasibility of future EECP studies. The results of this study could provide evidence that can help active duty and Department of Defense beneficiaries optimize physical conditioning, endurance and overall health. It could help active duty members maximize their physical training potential enabling them to better prepare for missions down range. Additionally, physiologic cardiopulmonary improvements may have the potential to decrease the conditioning time required for injured, post-operative and post-partum active duty members to return to duty.
研究设计
- 研究类型
- 干预性
- 分配方式
- 不适用
- 干预模型
- 单组
- 主要目的
- 治疗
- 盲法
- 开放（无盲法）
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 active-duty military personnel or DoD beneficiaries
- Medically cleared for the 1.5 mile run test [subjects will be medically cleared via PI's discretion or physician consultation letter]
- 18 years or older [no age cutoff is needed, subjects will be medically cleared via PI's discretion or physician consultation letter]
- Scoring below 55 out of 60 points on a 1.5 mile run portion of test using current AFI fitness standards [adjusted for age and gender]
- Maintaining a steady work-out routine and agreeing to adhere to it for the duration of the study. The workouts cannot vary by greater than 50% week to week (e.g. a subject that works out 3 hours on week 1, can only work out between 1.5 to 4.5 hours on week 2).
- Dermatological conditions not impacted by the EECP procedure will be allowed to enroll (e.g. eczema).
排除标准
- Pregnancy or anticipated pregnancy
- Exemption from PT (run portion of physical fitness test)
- VO2MAX greater than 55 mL/kg/min [determined from baseline CPX]
- Scheduled permanent change in station within 3 months
- Any significant co-morbid health conditions medically classifying the subject as not healthy [at PI's discretion], including but not limited to the following.
- Previous myocardial infarction, hernias, aneurysms, retinal detachments (unless fixed by laser surgery), macular edema, chest pain, ocular bleeding or seizures
- Risk of pulmonary edema
- Diagnosed with diabetes, heart failure, atrial fibrillation or epilepsy
- Coagulopathy with an INR of prothrombin time > 2.5
- Valvular heart disease
- Blood pressure >140/100 mmHg or <90/60 mmHg upon clinic visit
- Subjects with heart rates >120 bpm upon clinic visit
- Subjects with implantable cardioverter-defibrillator or pacemaker
- History of deep vein thrombosis
- History of pulmonary embolism
- Family history of individuals with multiple pulmonary embolisms or young onset pulmonary embolism (< 65 years old)
- Bleeding diathesis
- Presence of abdominal surgery within the past 6 months in EMR
研究组 & 干预措施
EECP Treatment
35 one hour (1hr) sessions of Enhanced External Counterpulsation (EECP).
干预措施: Enhanced External Counterpulsation (EECP) (Device)
结局指标
主要结局
VO2 MAX
时间窗: 7 weeks
The primary endpoint will be the change from baseline in VO2 MAX over the 7-week EECP treatment period.
次要结局
- 1.5 run run(7 weeks)
研究者
研究点 (1)
标识符
- NCT 编号
- NCT02517671
- 其他研究编号
- FDG20140034H
日期
- 首次提交
- (11年前)
- 首次发布
- (11年前)
- 主要完成日期
- (8年前)
- 研究完成日期
- (8年前)
- 最近核实
- (8年前)
- 最近更新
- (8年前)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 是否有结果
- 否