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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04508478
Other study ID # 202007030RIN
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date November 3, 2021
Est. completion date December 31, 2024

Study information

Verified date April 2023
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To test the impacts of different exercise training programs to the cardiopulmonary function, muscle metabolism, and body mass composition


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 100
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 20 Years to 90 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Aerobic training
Aerobic training
Resistance training
Resistance training
Control physical exercise
Control physical exercise

Locations

Country Name City State
Taiwan National Taiwan University Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary AF burden AF burden on 14 day ECG 5 months
Primary CPET/6 minute walking test CPET/6 minute walking test 5 months
Primary DEXA/muscle MRI DEXA/muscle MRI 5 months
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