Cardiac Rehabilitation After Pacemaker Implantation

NCT ID: NCT05015075

Last Updated: 2021-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-10

Study Completion Date

2019-08-17

Brief Summary

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

Detailed Description

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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).

Conditions

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Bradycardia Pacemaker

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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CR group

participants who have exercise-based cardiac rehabilitation program after PM.

Group Type EXPERIMENTAL

cardiac rehabilitation

Intervention Type BEHAVIORAL

cardiac rehabilitation after pacemaker implantation

non-CR group

participants who have only routine regular follow-up after PM instead of CR program

Group Type PLACEBO_COMPARATOR

cardiac rehabilitation

Intervention Type BEHAVIORAL

cardiac rehabilitation after pacemaker implantation

Interventions

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cardiac rehabilitation

cardiac rehabilitation after pacemaker implantation

Intervention Type BEHAVIORAL

Other Intervention Names

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exercise-based cardiac rehabilitation: step-box, lower extremity recumbent ergometer

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pusan National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jinhee Ahn, MD

Clinical associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Jinhee Ahn

Busan, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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H-1803-017-064

Identifier Type: -

Identifier Source: org_study_id

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