Exercise-based Cardiac Rehabilitation After Thoracoscopic... | NCT04500184

Studies
Exercise-based Cardiac Rehabilitation After Thoracoscopic Ablation in Patients With Persisent Atrial Fibrillation

NCT04500184

Sponsor

Samsung Medical Center

Status

Completed

Last Update Posted

Aug 5, 2020Actual

Enrollment

24Actual

Phase

Not provided

Conditions

Atrial Fibrillation, Persistent
Cardiac Rehabilitation
Cardiopulmonary Fitness

Interventions

cardiac rehabilitation

Countries

South Korea

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

Jul 2020

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

Jun 1, 2017Actual

Primary Completion Date

May 30, 2018Actual

Completion Date

May 31, 2020Actual

First Submitted Date

Jul 24, 2020

First Submission Date that Met QC Criteria

Jul 31, 2020

First Posted Date

Aug 5, 2020Actual

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 31, 2020

Last Update Posted Date

Aug 5, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Thoracoscopic ablation is a promising treatment of persistent atrial fibrillation. However, the postoperative rehabilitation is very important to prevent early recurrence of atrial arrhythmia. The purpose of this study is to evaluate the efficacy of professional cardiac rehabilitation in patients after thoracoscopic ablation.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Exercise group		patients who underwent cardiac rehabilitation	Other: cardiac rehabilitation
Control group		patients who did not undergo cardiac rehabilitation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cardiac rehabilitation	Other	rehabilitation performed by professional trainers	Exercise group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Recurrence of atrial fibrillation	Atrial fibrillation recurrence after surgical treatment	every 6 months for 1 year
functional recovery	exercise capacity and international physical activity questionnaire	6 months after intervention

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients who underwent thoracoscopic ablation due to persisent atrial fibrillation

Exclusion Criteria:

below 18 years
over 80 years old
malignancy
pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients who underwent thoracoscopic ablation were included. cardiac rehabilitation was performed according to the willingness of each patients.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dong Seop Jeong, PhD	Samsung Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Samsung Medical Center		Seoul		135-710	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000072038	Cardiac Rehabilitation

Ancestor Terms

ID	Term
D012046	Rehabilitation
D000359	Aftercare
D003266	Continuity of Patient Care
D005791	Patient Care

Browse Leaves

Not provided

Browse Branches

Not provided