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

• Sponsor: Chi-Ming Chu (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05080023
• Collaborator: Dr. Chiang, Shang-lin (Other), Dr. Liang-Cheng Chen (Other)
• Enrollment: 10
• Locations: 5
• Anticipated Duration (Months): 21.3
• Patients Per Site: 2
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Enhanced External Counterpulsation (EECP); Cardiac Output; Cardiac Force Index	Device: Enhanced External Counterpulsation (EECP)

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 10 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Impact of Enhanced External Counterpulsation (EECP) on Cardiac Force Index
• Anticipated Study Start Date: Feb 22, 2022
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2023

Outcome Measures

Primary Outcome Measures

1. Enhanced External Counterpulsation (EECP) on cardiac force index [4 weeks]

   Enhanced External Counterpulsation (EECP) on cardiac force index

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• can walk.

Exclusion Criteria:

• disabilities.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Local Clinics	Hualien City		Taiwan
2	Local Clinics	Kaohsiung		Taiwan
3	Local Clinics	Taichung		Taiwan
4	National Defense Medical Center	Taipei		Taiwan	114
5	Local Clinics	Taoyuan		Taiwan

Sponsors and Collaborators

• Chi-Ming Chu
• Dr. Chiang, Shang-lin
• Dr. Liang-Cheng Chen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• Responsible Party: Chi-Ming Chu, Prof. Dr., National Defense Medical Center, Taiwan
• ClinicalTrials.gov Identifier: NCT05080023
• Other Study ID Numbers: 1-104-05-147
• First Posted: Oct 15, 2021
• Last Update Posted: Feb 23, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Chi-Ming Chu, Prof. Dr., National Defense Medical Center, Taiwan: cardiac force index; Cardiac Output; Enhanced External Counterpulsation (EECP)

Study Results

No Results Posted as of Feb 23, 2022