Impact of Enhanced External Counterpulsation (EECP) on Ca... | NCT05080023

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

NCT05080023

Sponsor

Chi-Ming Chu

Status

Unknown status

Last Update Posted

Feb 23, 2022Actual

Enrollment

10Estimated

Phase

Not provided

Conditions

Enhanced External Counterpulsation (EECP)
Cardiac Output
Cardiac Force Index

Interventions

Enhanced External Counterpulsation (EECP)

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 22, 2022Estimated

Primary Completion Date

Dec 2022Estimated

Completion Date

Dec 2023Estimated

First Submitted Date

Oct 4, 2021

First Submission Date that Met QC Criteria

Oct 4, 2021

First Posted Date

Oct 15, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 22, 2022

Last Update Posted Date

Feb 23, 2022Actual

Name	Class
Dr. Chiang, Shang-lin	UNKNOWN
Dr. Liang-Cheng Chen	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

4 Weeks

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Enhanced External Counterpulsation (EECP)	Device	Enhanced External Counterpulsation (EECP)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Enhanced External Counterpulsation (EECP) on cardiac force index	Enhanced External Counterpulsation (EECP) on cardiac force index	4 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

can walk.

Exclusion Criteria:

disabilities.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Subjects can walk with a cardiac force meter.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Chi-Ming Chu, Dr.sc.hum.	Contact	+886-8792-3100	18438	chuchiming@web.de

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Local Clinics	Recruiting	Hualien City			Taiwan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32706725	Background	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.
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