NCT02517671

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 7, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 7, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 7, 2017

Completed
Last Updated

March 27, 2018

Status Verified

March 1, 2018

Enrollment Period

2.8 years

First QC Date

August 3, 2015

Last Update Submit

March 23, 2018

Conditions

Cardiovascular DiseasePulmonary Disease

Keywords

FitnessRun timeVO2maxVEGFCentral blood pressureAugmentation IndexPulse wave analysis

Outcome Measures

Primary Outcomes (1)

  • VO2 MAX

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

    7 weeks

Secondary Outcomes (1)

  • 1.5 run run

    7 weeks

Other Outcomes (4)

  • Exploratory endpoints peripheral blood pressures

    7 weeks

  • Exploratory endpoints Central Blood Pressure

    7 weeks

  • Exploratory endpoints Augmentation index

    7 weeks

  • +1 more other outcomes

Study Arms (1)

EECP Treatment

OTHER

35 one hour (1hr) sessions of Enhanced External Counterpulsation (EECP).

Device: Enhanced External Counterpulsation (EECP)

Interventions

Enhanced External Counterpulsation (EECP)DEVICE

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.

EECP Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy active-duty military personnel or DoD beneficiaries
  • Medically cleared for the 1.5 mile run test \[subjects will be medically cleared via PI's discretion or physician consultation letter\]
  • 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).

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

David Grant AF Medical Center

Travis Air Force Base, California, 94535, United States

Location

MeSH Terms

Conditions

Cardiovascular DiseasesLung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

  • Sokunthea Peou, Pharmacist

    David Grant Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2015

First Posted

August 7, 2015

Study Start

January 1, 2015

Primary Completion

October 7, 2017

Study Completion

October 7, 2017

Last Updated

March 27, 2018

Record last verified: 2018-03

Locations

US(1)