Impact of Enhanced External Counterpulsation (EECP) on VO2 MAX

Not Applicable

Withdrawn

• Conditions: Cardiovascular Disease; Pulmonary Disease
• Interventions: Device: Enhanced External Counterpulsation (EECP)

• Registration Number: NCT02517671
• Lead Sponsor: David Grant U.S. Air Force Medical Center

Brief 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.

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 Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-08-03
• Study First Submitted QC: 2015-08-06
• Study First Posted: 2015-08-07
• Primary Completion: 2017-10-07
• Study Completion: 2017-10-07
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-23
• Last Update Posted: 2018-03-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EECP Treatment	Enhanced External Counterpulsation (EECP)	35 one hour (1hr) sessions of Enhanced External Counterpulsation (EECP).

Primary Outcome Measures

Name	Time	Method
VO2 MAX	7 weeks	The primary endpoint will be the change from baseline in VO2 MAX over the 7-week EECP treatment period.

Secondary Outcome Measures

Name	Time	Method
1.5 run run	7 weeks	The secondary endpoint will be the change in 1.5 mile run time pre/post a 7-week course of EECP therapy.

Trial Locations

Locations (1)

David Grant AF Medical Center; 🇺🇸 Travis Air Force Base, California, United States