Impact of Enhanced External Counterpulsation (EECP) on VO2 MAX (NCT02517671) | Clinical Trial Compass
WithdrawnNot Applicable
Impact of Enhanced External Counterpulsation (EECP) on VO2 MAX
Stopped: PI failed to file continuation report.
United States0Started 2015-01
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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).
Exclusion Criteria:
* 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 f…