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

NCT05080023 | Unknown FDA Device

• 1 other identifier: 1-104-05-147
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 5

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.

Conditions

Enhanced External Counterpulsation (EECP); Cardiac Output; Cardiac Force Index

Keywords

cardiac force index; Cardiac Output; Enhanced External Counterpulsation (EECP)

Outcome Measures

Primary Outcomes (1)

• Enhanced External Counterpulsation (EECP) on cardiac force index

  Enhanced External Counterpulsation (EECP) on cardiac force index

  4 weeks

Interventions

Enhanced External Counterpulsation (EECP) DEVICE

Enhanced External Counterpulsation (EECP)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects can walk with a cardiac force meter.

You may qualify if:

• can walk.

You may not qualify if:

• disabilities.

Sponsors & Collaborators

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

Study Sites (5)

Local Clinics

Hualien City, Taiwan

RECRUITING

Local Clinics

Kaohsiung City, Taiwan

RECRUITING

Local Clinics

Taichung, Taiwan

RECRUITING

National Defense Medical Center

Taipei, 114, Taiwan

RECRUITING

Local Clinics

Taoyuan District, Taiwan

RECRUITING

Related Publications (2)

• 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.

  PMID: 32706725 BACKGROUND

• 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):8832. doi: 10.3390/ijerph18168832.

  PMID: 34444580 BACKGROUND

Central Study Contacts

Chi-Ming Chu, Dr.sc.hum.

CONTACT

+886-8792-3100; chuchiming@web.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: October 4, 2021
• First Posted: October 15, 2021
• Study Start: February 22, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: February 23, 2022

Record last verified: 2022-02

Locations

TW (5)