Effect of Standardized Exercise on Cardiopulmonary Functi... | NCT04957771

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

NCT04957771

Sponsor

Peking University Third Hospital

Status

Completed

Last Update Posted

Jul 12, 2021Actual

Enrollment

64Actual

Phase

Not Applicable

Conditions

Pacemaker DDD
Cardiopulmonary Endurance

Interventions

Supervise and guide regular exercise

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2019Actual

Primary Completion Date

Jul 31, 2020Actual

Completion Date

Jul 31, 2020Actual

First Submitted Date

Jun 27, 2021

First Submission Date that Met QC Criteria

Jul 4, 2021

First Posted Date

Jul 12, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 4, 2021

Last Update Posted Date

Jul 12, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

64Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Regular exercise group	Experimental		Other: Supervise and guide regular exercise
non-regurlar exercise group	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Supervise and guide regular exercise	Other	Aerobic exercise, evaluated by cardiopulmonary exercise test, 3-5 times a week	Regular exercise group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
lijie sun, MD	Peking University Third Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking University Third Hospital		Beijing	Haidian	100191	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided