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

• Sponsor: Peking University Third Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04957771
• Collaborator: (none)
• Enrollment: 64
• Location: 1
• Arms: 2
• Actual Duration (Months): 12
• Patients Per Site Per Month: 5.3

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Pacemaker DDD; Cardiopulmonary Endurance	Other: Supervise and guide regular exercise	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 64 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Effect of Standardized Exercise on Cardiopulmonary Function in Patients With Permanent Pacemaker Implantation
• Actual Study Start Date: Aug 1, 2019
• Actual Primary Completion Date: Jul 31, 2020
• Actual Study Completion Date: Jul 31, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Parameters related to exercise cardiopulmonary assessment [followed up for one year]

   VO2peak

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking University Third Hospital	Beijing	Haidian	China	100191

Sponsors and Collaborators

• Peking University Third Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Peking University Third Hospital
• ClinicalTrials.gov Identifier: NCT04957771
• Other Study ID Numbers: LM2019185
• First Posted: Jul 12, 2021
• Last Update Posted: Jul 12, 2021
• Last Verified: Aug 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jul 12, 2021