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Cardiac Rehabilitation After Pacemaker Implantation

Primary Purpose

Bradycardia, Pacemaker

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
cardiac rehabilitation
Sponsored by
Pusan National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bradycardia

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jinhee Ahn

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CR group

non-CR group

Arm Description

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

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

Outcomes

Primary Outcome Measures

changes in physical function based on cardiopulmonary exercise test
VO2 max in mL/kg/min

Secondary Outcome Measures

changes in physical function based on muscle power test
knee extension in kilogram
changes in quality of life
SF-36 questionnaire score

Full Information

First Posted
July 27, 2021
Last Updated
August 14, 2021
Sponsor
Pusan National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05015075
Brief Title
Cardiac Rehabilitation After Pacemaker Implantation
Official Title
Role of Early Short-term Cardiac Rehabilitation in Patients Undergoing Pacemaker Implantation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
April 10, 2018 (Actual)
Primary Completion Date
January 11, 2019 (Actual)
Study Completion Date
August 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pusan National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bradycardia, Pacemaker

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CR group
Arm Type
Experimental
Arm Description
participants who have exercise-based cardiac rehabilitation program after PM.
Arm Title
non-CR group
Arm Type
Placebo Comparator
Arm Description
participants who have only routine regular follow-up after PM instead of CR program
Intervention Type
Behavioral
Intervention Name(s)
cardiac rehabilitation
Other Intervention Name(s)
exercise-based cardiac rehabilitation: step-box, lower extremity recumbent ergometer
Intervention Description
cardiac rehabilitation after pacemaker implantation
Primary Outcome Measure Information:
Title
changes in physical function based on cardiopulmonary exercise test
Description
VO2 max in mL/kg/min
Time Frame
1 month
Secondary Outcome Measure Information:
Title
changes in physical function based on muscle power test
Description
knee extension in kilogram
Time Frame
1 month
Title
changes in quality of life
Description
SF-36 questionnaire score
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Jinhee Ahn
City
Busan
Country
Korea, Republic of

12. IPD Sharing Statement

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Cardiac Rehabilitation After Pacemaker Implantation

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