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Exercise Training to Atrial Fibrillation (ExAF)

Primary Purpose

Atrial Fibrillation

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Aerobic training
Resistance training
Control physical exercise
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial Fibrillation, weight training, aerobic training, cardio-pulmonary function

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Paroxysmal or persistent atrial fibrillation
  2. Daily activity below moderate intensity < 300 minutes or high intensity < 150 minutes per week.

Exclusion Criteria:

  1. Active infection.
  2. Implant cardiac pacemaker.
  3. Uncontrolled hypertension.
  4. Cardiopulmonary contraindication to exercise training, such as decompensated heart failure, acute pulmonary edema, unstable angina, uncontrolled arrhythmia causing hemodynamic compromise, symptomatic severe aortic stenosis, suspected dissecting aortic aneurysm, severe pulmonary hypertension, acute myocarditis, endocarditis or pericarditis, uncontrolled asthma and SpO2 < 90% at rest on room air.
  5. Inability to follow verbal command or to walk on treadmill or use stationary bike.

Sites / Locations

  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Aerobic training

Resistance training

Control

Arm Description

Outcomes

Primary Outcome Measures

AF burden
AF burden on 14 day ECG
CPET/6 minute walking test
CPET/6 minute walking test
DEXA/muscle MRI
DEXA/muscle MRI

Secondary Outcome Measures

Full Information

First Posted
August 9, 2020
Last Updated
April 17, 2023
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04508478
Brief Title
Exercise Training to Atrial Fibrillation
Acronym
ExAF
Official Title
The Impact of Exercise Training to Patients With Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 3, 2021 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To test the impacts of different exercise training programs to the cardiopulmonary function, muscle metabolism, and body mass composition
Detailed Description
Atrial fibrillation (AF) has been a global threat due to its increasing incidence and prevalence, and also its potential complications of embolic stroke and heart failure, and therefore has a great impact on life expectancy and quality of life. AF with preserved ventricular function is associated with exercise intolerance, and the effect of physical training had shown to improve life quality and heart function in the population. However, the optimal physical training modalities and intensities are not well studies. Here we conduct a prospective, randomized, and interventional trial to investigate the effects of different exercise training programs to the burden of AF. We also exploit advanced imaging modalities, including dual x-ray absorptiometry and muscle magnetic resonance, to explore the change of body mass compositions. With this project, we will be able to explore the effects of different physical exercise modalities to the burden of AF and heart function, and also build up a best exercise training program, specific for this population.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial Fibrillation, weight training, aerobic training, cardio-pulmonary function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aerobic training
Arm Type
Experimental
Arm Title
Resistance training
Arm Type
Active Comparator
Arm Title
Control
Arm Type
Placebo Comparator
Intervention Type
Behavioral
Intervention Name(s)
Aerobic training
Intervention Description
Aerobic training
Intervention Type
Behavioral
Intervention Name(s)
Resistance training
Intervention Description
Resistance training
Intervention Type
Behavioral
Intervention Name(s)
Control physical exercise
Intervention Description
Control physical exercise
Primary Outcome Measure Information:
Title
AF burden
Description
AF burden on 14 day ECG
Time Frame
5 months
Title
CPET/6 minute walking test
Description
CPET/6 minute walking test
Time Frame
5 months
Title
DEXA/muscle MRI
Description
DEXA/muscle MRI
Time Frame
5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Paroxysmal or persistent atrial fibrillation Daily activity below moderate intensity < 300 minutes or high intensity < 150 minutes per week. Exclusion Criteria: Active infection. Implant cardiac pacemaker. Uncontrolled hypertension. Cardiopulmonary contraindication to exercise training, such as decompensated heart failure, acute pulmonary edema, unstable angina, uncontrolled arrhythmia causing hemodynamic compromise, symptomatic severe aortic stenosis, suspected dissecting aortic aneurysm, severe pulmonary hypertension, acute myocarditis, endocarditis or pericarditis, uncontrolled asthma and SpO2 < 90% at rest on room air. Inability to follow verbal command or to walk on treadmill or use stationary bike.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chih-Chieh Yu, MD.PhD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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Exercise Training to Atrial Fibrillation

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