Clinical trial NCT02517671: Impact of Enhanced External Counterpulsation (EECP) on VO2 MAX
Official title: Impact of Enhanced External Counterpulsation (EECP) on VO2 MAX
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cardiovascular Disease
Pulmonary Disease
Keywords: Fitness
Run time
VO2max
VEGF
Central blood pressure
Augmentation Index
Pulse wave analysis
Lead sponsor: David Grant U.S. Air Force Medical Center
Sponsor class: FED
First posted: 2015-08-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: VO2 MAX
timeFrame: 7 weeks
Secondary outcomes:
measure: 1.5 run run
timeFrame: 7 weeks
Other outcomes:
measure: Exploratory endpoints peripheral blood pressures
timeFrame: 7 weeks
measure: Exploratory endpoints Central Blood Pressure
timeFrame: 7 weeks
measure: Exploratory endpoints Augmentation index
timeFrame: 7 weeks
measure: Exploratory endpoints VEGF
timeFrame: 7 weeks
Locations:
city: Travis Air Force Base
country: United States
facility: David Grant AF Medical Center
state: California
Study officials:
affiliation: David Grant Medical Center
name: Sokunthea Peou, Pharmacist
role: PRINCIPAL_INVESTIGATOR
References: