Cardiac Rehabilitation After Pacemaker Implantation

August 14, 2021 updated by: Jinhee Ahn, MD, Pusan National University Hospital

Role of Early Short-term Cardiac Rehabilitation in Patients Undergoing Pacemaker Implantation

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CR group
participants who have exercise-based cardiac rehabilitation program after PM.
Behavioral: cardiac rehabilitation
cardiac rehabilitation after pacemaker implantation
Other Names:
  • exercise-based cardiac rehabilitation: step-box, lower extremity recumbent ergometer
Placebo Comparator: non-CR group
participants who have only routine regular follow-up after PM instead of CR program
Behavioral: cardiac rehabilitation
cardiac rehabilitation after pacemaker implantation
Other Names:
  • exercise-based cardiac rehabilitation: step-box, lower extremity recumbent ergometer

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pusan National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2018

Primary Completion (Actual)

January 11, 2019

Study Completion (Actual)

August 17, 2019

Study Registration Dates

First Submitted

July 27, 2021

First Submitted That Met QC Criteria

August 14, 2021

First Posted (Actual)

August 20, 2021

Study Record Updates

Last Update Posted (Actual)

August 20, 2021

Last Update Submitted That Met QC Criteria

August 14, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-1803-017-064

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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