Effect of Standardized Exercise on Cardiopulmonary Function in Patients With Permanent Pacemaker Implantation

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

Study Overview

• Status: Completed
• Conditions: Pacemaker DDD; Cardiopulmonary Endurance
• Intervention / Treatment: Other: Supervise and guide regular exercise

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Haidian
    • Beijing, Haidian, China, 100191
      • Peking University Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18-75 years old patients with pacemaker implantation for the first time,
• 3-6 months after operation
• stable condition,
• independent walking ability.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Regular exercise group	Other: Supervise and guide regular exercise; Aerobic exercise, evaluated by cardiopulmonary exercise test, 3-5 times a week
No Intervention: non-regurlar exercise group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parameters related to exercise cardiopulmonary assessment	VO2peak	followed up for one year

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Principal Investigator: lijie sun, MD, Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Actual): July 31, 2020
• Study Completion (Actual): July 31, 2020

Study Registration Dates

• First Submitted: June 27, 2021
• First Submitted That Met QC Criteria: July 4, 2021
• First Posted (Actual): July 12, 2021

Study Record Updates

• Last Update Posted (Actual): July 12, 2021
• Last Update Submitted That Met QC Criteria: July 4, 2021
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: LM2019185

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No