NCT04957771

Brief Summary

The purpose of this study is to observe the changes of cardiopulmonary endurance in patients with pacemaker implantation after long-term exercise, to explore the significance of exercise on patients with pacemaker implantation, and to analyze the difference of the effect of exercise on cardiopulmonary endurance in patients with normal LVEF of different pacing ratios

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2019

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

August 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 12, 2021

Completed
Last Updated

July 12, 2021

Status Verified

August 1, 2019

Enrollment Period

1 year

First QC Date

June 27, 2021

Last Update Submit

July 4, 2021

Conditions

Pacemaker DDDCardiopulmonary Endurance

Outcome Measures

Primary Outcomes (1)

  • Parameters related to exercise cardiopulmonary assessment

    VO2peak

    followed up for one year

Study Arms (2)

Regular exercise group

EXPERIMENTAL
Other: Supervise and guide regular exercise

non-regurlar exercise group

NO INTERVENTION

Interventions

Supervise and guide regular exerciseOTHER

Aerobic exercise, evaluated by cardiopulmonary exercise test, 3-5 times a week

Regular exercise group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old patients with pacemaker implantation for the first time,
  • months after operation
  • stable condition,
  • independent walking ability.

You may not qualify if:

  • Cognitive impairment;
  • ICD, CRT / Crtd implanted,
  • patients with neurogenic syncope;
  • Atrial tachycardia, atrial fibrillation,
  • NYHA class II or above,
  • difficult to control hypertension;
  • Musculoskeletal disease limiting activity
  • nervous system disease,
  • severe respiratory disease,
  • Patients with acute inflammation,
  • cancer and other diseases uncontrolled.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, Haidian, 100191, China

Location

Study Officials

  • lijie sun, MD

    Peking University Third Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2021

First Posted

July 12, 2021

Study Start

August 1, 2019

Primary Completion

July 31, 2020

Study Completion

July 31, 2020

Last Updated

July 12, 2021

Record last verified: 2019-08

Locations

CN(1)