Impact of Enhanced External Counterpulsation (EECP) on VO2 MAX

Cardiovascular Disease Clinical Trial

Official title:

Impact of Enhanced External Counterpulsation (EECP) on VO2 MAX

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02517671
• Other study ID #: FDG20140034H
• Status: Withdrawn
• Phase: N/A
• First received: August 3, 2015
• Last updated: March 23, 2018
• Start date: January 2015
• Est. completion date: October 7, 2017

Study information

• Verified date: March 2018
• Source: David Grant U.S. Air Force Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 7, 2017
• Est. primary completion date: October 7, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Lung Diseases
• Pulmonary Disease

Intervention

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.

Locations

Country	Name	City	State
United States	David Grant AF Medical Center	Travis Air Force Base	California

Sponsors (1)

Lead Sponsor	Collaborator
David Grant U.S. Air Force Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory endpoints peripheral blood pressures	Assessment of peripheral blood pressures levels.	7 weeks
Other	Exploratory endpoints Central Blood Pressure	Assessment of Central Blood Pressure levels	7 weeks
Other	Exploratory endpoints Augmentation index	Assessment of Augmentation index	7 weeks
Other	Exploratory endpoints VEGF	Assessment of VEGF	7 weeks
Primary	VO2 MAX	The primary endpoint will be the change from baseline in VO2 MAX over the 7-week EECP treatment period.	7 weeks
Secondary	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.	7 weeks