Cardiac Rehabilitation After Pacemaker Implantation | NCT05015075

Studies
Cardiac Rehabilitation After Pacemaker Implantation

NCT05015075

Sponsor

Pusan National University Hospital

Status

Completed

Last Update Posted

Aug 20, 2021Actual

Enrollment

27Actual

Phase

Phase 4

Conditions

Bradycardia
Pacemaker

Interventions

cardiac rehabilitation

Countries

South Korea

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

Aug 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 10, 2018Actual

Primary Completion Date

Jan 11, 2019Actual

Completion Date

Aug 17, 2019Actual

First Submitted Date

Jul 27, 2021

First Submission Date that Met QC Criteria

Aug 14, 2021

First Posted Date

Aug 20, 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

Aug 14, 2021

Last Update Posted Date

Aug 20, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jinhee Ahn, MD, Clinical associate professor, Pusan National University HospitalPrincipal Investigator

Lead Sponsor

Pusan National University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The investigators assessed whether short-term cardiac rehabilitation following pacemaker implantation was enough to improve both physical function and quality of life.

Detailed Description

Exercise-based cardiac rehabilitation (CR) improves clinical outcomes in patients with cardiovascular diseases. However, few data exist regarding the role of early short-term CR in patients undergoing pacemaker (PM) implantation. The investigators assessed whether short-term CR following PM implantation was enough to improve both physical function and quality of life (QOL).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

27Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CR group	Experimental	participants who have exercise-based cardiac rehabilitation program after PM.	Behavioral: cardiac rehabilitation
non-CR group	Placebo Comparator	participants who have only routine regular follow-up after PM instead of CR program	Behavioral: cardiac rehabilitation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cardiac rehabilitation	Behavioral	cardiac rehabilitation after pacemaker implantation	CR group non-CR group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
changes in physical function based on cardiopulmonary exercise test	VO2 max in mL/kg/min	1 month

Secondary Outcomes

Measure	Description	Time Frame
changes in physical function based on muscle power test	knee extension in kilogram	1 month
changes in quality of life	SF-36 questionnaire score

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients who were scheduled to undergo new PM implantation

Exclusion Criteria:

patients older than 75 years
patients who are contraindicated to exercise
patients who refuse to participate

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001919	Bradycardia

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000072038	Cardiac Rehabilitation

Ancestor Terms

ID	Term
D012046	Rehabilitation
D000359	Aftercare
D003266	Continuity of Patient Care
D005791	Patient Care

Browse Leaves

Not provided

Browse Branches

Not provided