Impact of Enhanced External Counterpulsation (EECP) on VO2 MAX

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 Overview

• Status: Withdrawn
• Conditions: Cardiovascular Disease; Pulmonary Disease
• Intervention / Treatment: Device: Enhanced External Counterpulsation (EECP)

Detailed 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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Travis Air Force Base, California, United States, 94535
      • David Grant AF Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: EECP Treatment; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VO2 MAX	The primary endpoint will be the change from baseline in VO2 MAX over the 7-week EECP treatment period.	7 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory endpoints peripheral blood pressures	Assessment of peripheral blood pressures levels.	7 weeks
Exploratory endpoints Central Blood Pressure	Assessment of Central Blood Pressure levels	7 weeks
Exploratory endpoints Augmentation index	Assessment of Augmentation index	7 weeks
Exploratory endpoints VEGF	Assessment of VEGF	7 weeks

Collaborators and Investigators

• Sponsor: David Grant U.S. Air Force Medical Center
• Investigators: Principal Investigator: Sokunthea Peou, Pharmacist, David Grant Medical Center

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): October 7, 2017
• Study Completion (Actual): October 7, 2017

Study Registration Dates

• First Submitted: August 3, 2015
• First Submitted That Met QC Criteria: August 6, 2015
• First Posted (Estimate): August 7, 2015

Study Record Updates

• Last Update Posted (Actual): March 27, 2018
• Last Update Submitted That Met QC Criteria: March 23, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: VEGF; Fitness; Run time; VO2max; Central blood pressure; Augmentation Index; Pulse wave analysis
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: FDG20140034H

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No