Enhanced External Counterpulsation (EECP)NCT05080023
Impact of Enhanced External Counterpulsation (EECP) on Cardiac Force Index
An observational study of Enhanced External Counterpulsation (EECP) and Cardiac Output, run by Chi-Ming Chu at 5 sites in Taiwan.
Trial summary
Regular exercise can prevent cardiovascular disease, but there is also a risk of sudden cardiac death. Exercise-related sudden death often occurs unconsciously and there is no relevant monitoring mechanism. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Enhanced External Counterpulsation (EECP), Cardiac Output, Cardiac Force Index
- What is being tested?
- Enhanced External Counterpulsation (EECP)
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 5 sitesTaiwan
- Study dates
- 22 Feb 2022to Dec 2023
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Subjects can walk with a cardiac force meter.
Who may be able to join
- can walk.
Who cannot join
- disabilities.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Taiwan5 sites, 5 recruiting
- Recruiting
Local Clinics
Hualien City
CM Chu, Dr. sc. hum.
- Recruiting
Local Clinics
Kaohsiung City
CM Chu, Dr. sc. hum., chuchiming@web.de
- Recruiting
Local Clinics
Taichung
CM Chu, Dr. sc. hum.
- Recruiting
National Defense Medical Center
Taipei, 114
CM Chu, Dr. sc. hum., 0919228173, chuchiming@web.de
CM Chu, Dr. sc. hum.
- Recruiting
Local Clinics
Taoyuan
CM Chu, Dr. sc. hum., chuchiming@web.de
About this study
Regular exercise can prevent cardiovascular disease, but there is also a risk of sudden cardiac death. Exercise-related sudden death often occurs unconsciously and there is no relevant monitoring mechanism. The patent of the Cardiac Force Index (CFI), invented by Professor Chu, is a method to detect the state of cardiac motion. Recent studies have confirmed Enhanced External Counterpulsation (EECP) can increase cardiopulmonary fitness and maximal oxygen consumption. Our aim is to investigate the differences and effects of CFI between two groups with and without 4 weeks of EECP intervention, therefore, to find out the relationship between CFI and maximum oxygen consumption (VO2max).
Methods: A pre and post-test control group was designed. A total of 53 military students (33 males and 20 females) were recruited and divided into intervention and control groups. A 2000-meter running and maximum oxygen consumption tests were performed pre and post-test. The intervention group was conducted a 4 week (3 times per week/30 minutes) EECP intervention.
- Being tested
- Enhanced External Counterpulsation (EECP)
- Keywords
- cardiac force index, Cardiac Output, Enhanced External Counterpulsation (EECP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced External Counterpulsation (EECP)Device
Enhanced External Counterpulsation (EECP)
What is being measured
The primary outcome is the main question the study is designed to answer.
Enhanced External Counterpulsation (EECP) on cardiac force index
Enhanced External Counterpulsation (EECP) on cardiac force index
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start22 Feb 2022 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Enhanced External Counterpulsation (EECP)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Chi-Ming Chu
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Chiang, Shang-lin, Dr. Liang-Cheng Chen
- Responsible party
- Sponsor-investigator, Chi-Ming Chu, National Defense Medical Center, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05080023
- Sponsor's protocol ID
- 1-104-05-147
- Status last verified
- Feb 2022
- First submitted
- 4 Oct 2021
- Last updated
- 23 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Hsiao PJ, Chiu CC, Lin KH, Hu FK, Tsai PJ, Wu CT, Pang YK, Lin Y, Kuo MH, Chen KH, Wu YS, Wu HY, Chang YT, Chang YT, Cheng CS, Chuu CP, Lin FH, Chang CW, Li YK, Chan JS, Chu CM. Usability of Wearable Devices With a Novel Cardiac Force Index for Estimating the Dynamic Cardiac Function: Observational Study. JMIR Mhealth Uhealth. 2020 Jul 21;8(7):e15331. doi: 10.2196/15331.
PubMed 32706725Chiang KT, Tu MY, Lin YJ, Hsin YH, Chiu YL, Li FL, Chen HH, Lai CY. A Cardiac Force Index Applied to the G Tolerance Test and Surveillance among Male Military Aircrew. Int J Environ Res Public Health. 2021 Aug 21;18(16):8832. doi: 10.3390/ijerph18168832.
PubMed 34444580
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Enhanced External Counterpulsation (EECP) on Cardiac Force Index
- ClinicalTrials.gov ID
- NCT05080023
- Acronym / sponsor ID
- 1-104-05-147
- Keywords
- cardiac force index, Cardiac Output, Enhanced External Counterpulsation (EECP)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Chi-Ming ChuUniversity, hospital or other
- Collaborators
- Dr. Chiang, Shang-lin, Dr. Liang-Cheng Chen
- Study start
- 22 Feb 2022 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 15 Oct 2021 (actual)
- 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.
Regular exercise can prevent cardiovascular disease, but there is also a risk of sudden cardiac death. Exercise-related sudden death often occurs unconsciously and there is no relevant monitoring mechanism. The patent of the Cardiac Force Index (CFI), invented by Professor Chu, is a method to detect the state of cardiac motion. Recent studies have confirmed Enhanced External Counterpulsation (EECP) can increase cardiopulmonary fitness and maximal oxygen consumption. Our aim is to investigate the differences and effects of CFI between two groups with and without 4 weeks of EECP intervention, therefore, to find out the relationship between CFI and maximum oxygen consumption (VO2max).
Methods: A pre and post-test control group was designed. A total of 53 military students (33 males and 20 females) were recruited and divided into intervention and control groups. A 2000-meter running and maximum oxygen consumption tests were performed pre and post-test. The intervention group was conducted a 4 week (3 times per week/30 minutes) EECP intervention.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects can walk with a cardiac force meter.
Key inclusion criteria (1 listed)
- can walk.
Key exclusion criteria (1 listed)
- disabilities.
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)Enhanced External Counterpulsation (EECP) | Device | – |
Primary outcome
Enhanced External Counterpulsation (EECP) on cardiac force index
Time frame: 4 weeks
Enhanced External Counterpulsation (EECP) on cardiac force index
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2022.
- Background: PubMed 32706725Hsiao PJ, Chiu CC, Lin KH, Hu FK, Tsai PJ, Wu CT, Pang YK, Lin Y, Kuo MH, Chen KH, Wu YS, Wu HY, Chang YT, Chang YT, Cheng CS, Chuu CP, Lin FH, Chang CW, Li YK, Chan JS, Chu CM. Usability of Wearable Devices With a Novel Cardiac Force Index for Estimating the Dynamic Cardiac Function: Observational Study. JMIR Mhealth Uhealth. 2020 Jul 21;8(7):e15331. doi: 10.2196/15331.
- Background: PubMed 34444580Chiang KT, Tu MY, Lin YJ, Hsin YH, Chiu YL, Li FL, Chen HH, Lai CY. A Cardiac Force Index Applied to the G Tolerance Test and Surveillance among Male Military Aircrew. Int J Environ Res Public Health. 2021 Aug 21;18(16):8832. doi: 10.3390/ijerph18168832.
- Individual participant dataSharing planned: Undecided
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Enhanced External Counterpulsation (EECP) and Cardiac Output, run by Chi-Ming Chu at 5 sites in Taiwan.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 23 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chi-Ming Chu, Dr.sc.hum. (+886-8792-3100 ext. 18438, chuchiming@web.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enhanced External Counterpulsation (EECP) on cardiac force index (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05080023, which also lists 2 linked publications.
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 23 Feb 2022.