Cardiovascular DiseaseNCT02517671
Impact of Enhanced External Counterpulsation (EECP) on VO2 MAX
A study testing Enhanced External Counterpulsation (EECP) in people with Cardiovascular Disease and Pulmonary Disease, run by David Grant U.S. Air Force Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease, Pulmonary Disease
- What is being tested?
- Enhanced External Counterpulsation (EECP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to 7 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
David Grant AF Medical Center
Travis Air Force Base, California, 94535
About this study
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.
Read the 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.
- Conditions
- Cardiovascular Disease, Pulmonary Disease
- Being tested
- Enhanced External Counterpulsation (EECP)
- Keywords
- Fitness, Run time, VO2max, VEGF, Central blood pressure, Augmentation Index, Pulse wave analysis
- Medical subject headings
- Cardiovascular Diseases, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| EECP Treatment | Other | 35 one hour (1hr) sessions of Enhanced External Counterpulsation (EECP). Receives: Device: Enhanced External Counterpulsation (EECP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2 MAX
The primary endpoint will be the change from baseline in VO2 MAX over the 7-week EECP treatment period.
Measured: 7 weeks
Secondary outcomes (1)
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.
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2015 (estimated)
- Study startJan 2015
- Primary completion7 Oct 2017 (estimated)
- Study completion7 Oct 2017
Why it stopped: PI failed to file continuation report.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- David Grant U.S. Air Force Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Sokunthea Peou, Pharmacist, Principal investigator, David Grant Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02517671
- Sponsor's protocol ID
- FDG20140034H
- Status last verified
- Mar 2018
- First submitted
- 3 Aug 2015
- Last updated
- 27 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Enhanced External Counterpulsation (EECP) on VO2 MAX
- ClinicalTrials.gov ID
- NCT02517671
- Acronym / sponsor ID
- FDG20140034H
- Conditions
- Cardiovascular Disease, Pulmonary Disease
- Keywords
- Fitness, Run time, VO2max, VEGF, Central blood pressure, Augmentation Index, Pulse wave analysis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI failed to file continuation report.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- David Grant U.S. Air Force Medical CenterUS federal agency
- Study start
- Jan 2015
- Primary completion
- 7 Oct 2017 (estimated)
- Study completion
- 7 Oct 2017 (actual)
- First posted
- 7 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EECP Treatment | Other | Device: Enhanced External Counterpulsation (EECP)35 one hour (1hr) sessions of Enhanced External Counterpulsation (EECP). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy active-duty military personnel or DoD beneficiaries
- 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).
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | EECP Treatment |
Primary outcome
VO2 MAX
Time frame: 7 weeks
The primary endpoint will be the change from baseline in VO2 MAX over the 7-week EECP treatment period.
1 secondary outcome
1.5 run run
Time frame: 7 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sokunthea Peou, Pharmacist principal investigator
David Grant Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced External Counterpulsation (EECP) in people with Cardiovascular Disease and Pulmonary Disease, run by David Grant U.S. Air Force Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VO2 MAX (time frame: 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2018.