NCT05015075

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 11, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 17, 2019

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

July 27, 2021

Completed
24 days until next milestone

First Posted

Study publicly available on registry

August 20, 2021

Completed
Last Updated

August 20, 2021

Status Verified

August 1, 2021

Enrollment Period

9 months

First QC Date

July 27, 2021

Last Update Submit

August 14, 2021

Conditions

BradycardiaPacemaker

Outcome Measures

Primary Outcomes (1)

  • changes in physical function based on cardiopulmonary exercise test

    VO2 max in mL/kg/min

    1 month

Secondary Outcomes (2)

  • changes in physical function based on muscle power test

    1 month

  • changes in quality of life

    1 month

Study Arms (2)

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

cardiac rehabilitationBEHAVIORAL

cardiac rehabilitation after pacemaker implantation

Also known as: exercise-based cardiac rehabilitation: step-box, lower extremity recumbent ergometer
CR groupnon-CR group

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients who were scheduled to undergo new PM implantation

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jinhee Ahn

Busan, South Korea

Location

MeSH Terms

Conditions

Bradycardia

Interventions

Cardiac Rehabilitation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical associate professor

Study Record Dates

First Submitted

July 27, 2021

First Posted

August 20, 2021

Study Start

April 10, 2018

Primary Completion

January 11, 2019

Study Completion

August 17, 2019

Last Updated

August 20, 2021

Record last verified: 2021-08

Locations

KR(1)