An interventional study of Enhanced External Counterpulsation (EECP) in Cardiovascular Disease and Pulmonary Disease, sponsored by David Grant U.S. Air Force Medical Center. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-27.
Sponsored by David Grant U.S. Air Force Medical Center · Not applicable, Interventional, and Treatment
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.
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.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 920 are open to participants now.
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Healthy active-duty military personnel or DoD beneficiaries
Exclusion Criteria:
Any significant co-morbid health conditions medically classifying the subject as not healthy [at PI's discretion], including but not limited to the following.
35 one hour (1hr) sessions of Enhanced External Counterpulsation (EECP).
Device: Enhanced External Counterpulsation (EECP)
EECP is a non-invasive therapy that has been approved by the United States Food and Drug Administration (FDA) for the management of refractory angina and heart failure. This study is using the device to potentially improve 1.5 mile run times and VO2max in healthy volunteers.
VO2 MAX
The primary endpoint will be the change from baseline in VO2 MAX over the 7-week EECP treatment period.
Time frame: 7 weeks
1.5 run run
The secondary endpoint will be the change in 1.5 mile run time pre/post a 7-week course of EECP therapy.
Time frame: 7 weeks
Exploratory endpoints peripheral blood pressures
Assessment of peripheral blood pressures levels.
Time frame: 7 weeks
Exploratory endpoints Central Blood Pressure
Assessment of Central Blood Pressure levels
Time frame: 7 weeks
Exploratory endpoints Augmentation index
Assessment of Augmentation index
Time frame: 7 weeks
Exploratory endpoints VEGF
Assessment of VEGF
Time frame: 7 weeks
This study is withdrawn, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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David Grant U.S. Air Force Medical Center