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Cardiac Rehabilitation After Pacemaker Implantation

Sponsor
Pusan National University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05015075
Collaborator
(none)
27
Enrollment
1
Location
2
Arms
16.2
Actual Duration (Months)
1.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: cardiac rehabilitation
 Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
27 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Role of Early Short-term Cardiac Rehabilitation in Patients Undergoing Pacemaker Implantation
Actual Study Start Date :
Apr 10, 2018
Actual Primary Completion Date :
Jan 11, 2019
Actual Study Completion Date :
Aug 17, 2019

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. changes in physical function based on cardiopulmonary exercise test [1 month]

      VO2 max in mL/kg/min

    Secondary Outcome Measures

    1. changes in physical function based on muscle power test [1 month]

      knee extension in kilogram

    2. changes in quality of life [1 month]

      SF-36 questionnaire score

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Jinhee Ahn Busan Korea, Republic of

    Sponsors and Collaborators

    • Pusan National University Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jinhee Ahn, MD, Clinical associate professor, Pusan National University Hospital
    ClinicalTrials.gov Identifier:
    NCT05015075
    Other Study ID Numbers:
    • H-1803-017-064
    First Posted:
    Aug 20, 2021
    Last Update Posted:
    Aug 20, 2021
    Last Verified:
    Aug 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Bradycardia

    Study Results

    No Results Posted as of Aug 20, 2021