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NCT05080023 Clinical Trial

Impact of Enhanced External Counterpulsation (EECP) on Cardiac Force Index

Cardiac Output Clinical Trial

Official title:
Impact of Enhanced External Counterpulsation (EECP) on Cardiac Force Index

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05080023
Other study ID # 1-104-05-147
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 22, 2022
Est. completion date December 2023

Study information
Verified date February 2022
Source National Defense Medical Center, Taiwan
Contact Chi-Ming Chu, Dr.sc.hum.
Phone +886-8792-3100
Email chuchiming@web.de
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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. 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 10
Est. completion date December 2023
Est. primary completion date December 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - can walk. Exclusion Criteria: - disabilities.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Enhanced External Counterpulsation (EECP)
Enhanced External Counterpulsation (EECP)

Locations
Country Name City State
Taiwan Local Clinics Hualien City
Taiwan Local Clinics Kaohsiung
Taiwan Local Clinics Taichung
Taiwan National Defense Medical Center Taipei
Taiwan Local Clinics Taoyuan

Sponsors (3)
Lead Sponsor Collaborator
Chi-Ming Chu Dr. Chiang, Shang-lin, Dr. Liang-Cheng Chen

Country where clinical trial is conducted

Taiwan, 

References & Publications (2)

Chiang 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). pii: 8832. doi: 10.3390/ijerph18168832. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Enhanced External Counterpulsation (EECP) on cardiac force index Enhanced External Counterpulsation (EECP) on cardiac force index 4 weeks
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