Expired Study
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Travis Air Force Base, California 94535


Purpose:

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.


Study summary:

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.


Criteria:

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 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


Study is Available At:


Original ID:

FDG20140034H


NCT ID:

NCT02517671


Secondary ID:


Study Acronym:


Brief Title:

Impact of Enhanced External Counterpulsation (EECP) on VO2 MAX


Official Title:

Impact of Enhanced External Counterpulsation (EECP) on VO2 MAX


Overall Status:

Withdrawn


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

David Grant U.S. Air Force Medical Center


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:

PI failed to file continuation report.


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:

Actual


Overall Contact Information

Official Name:Sokunthea Peou, Pharmacist
Principal Investigator
David Grant Medical Center

Study Dates

Start Date:January 2015
Completion Date:October 7, 2017
Completion Type:Actual
Primary Completion Date:October 7, 2017
Primary Completion Type:Anticipated
Verification Date:March 2018
Last Changed Date:March 23, 2018
First Received Date:August 3, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:1.5 run run
Time Frame:7 weeks
Safety Issues:False
Description:The secondary endpoint will be the change in 1.5 mile run time pre/post a 7-week course of EECP therapy.
Outcome Type:Primary Outcome
Measure:VO2 MAX
Time Frame:7 weeks
Safety Issues:False
Description:The primary endpoint will be the change from baseline in VO2 MAX over the 7-week EECP treatment period.

Study Interventions

Intervention Type:Device
Name:Enhanced External Counterpulsation (EECP)
Description: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.
Arm Name:EECP Treatment

Study Arms

Study Arm Type:Other
Arm Name:EECP Treatment
Description:35 one hour (1hr) sessions of Enhanced External Counterpulsation (EECP).

Study Agencies

Agency Class:U.S. Fed
Agency Type:Lead Sponsor
Agency Name:David Grant U.S. Air Force Medical Center

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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