Effects of Exercise Training in Patients With Permanent Atrial Fibrillation
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
Exercise training
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial Fibrillation, Exercise Training, Endothelial Function, Autonomic Nerve Modulation, Exercise Capacity, Quality of Life
Eligibility Criteria
Inclusion Criteria:
- Permanent atrial fibrillation≥ 1 year aged 40-76 years
- Recurrence AF after ablation
- Under antiarrhythmia medication control
Exclusion Criteria:
- CAD or myocardial infrarction history
- NYHA≥ III-IV, or LVEF≤45%
- Mitral or aortic valve regurgitation ≥ Gr. II
- Mitral valve or aortic valve stenosis
- Pacemaker
- Cardioversion by ablation
- Pulmonary artery hypertension
- Any surgery in previous 3 months
- Any neurological disorders
- Cancer
- Severe musculoskeletal disorder
- Hyperthyroidism
- Premenopausal women
Sites / Locations
- National Taiwan University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Exercise training
control group
Arm Description
Exercise group will undergo progressively aerobic exercise training with 40-85% maximal oxygen consumption for 40 minutes, 3 sessions per week for 12 weeks.
Control group conducted the usual care
Outcomes
Primary Outcome Measures
Change of exercise capacity (after intervention)
To measure maximal oxygen consumption, maximal oxygen pulse, maximal heart rate and blood pressure, cumulated and peak workload by cycle ergometer with Vmax 229 system
Secondary Outcome Measures
Change of heart rate variability (after intervention)
To record ECG by lead V1 with KENZ 170 on supine position for 1 hour
Change values of head up tilt test (after intervention)
Subjects were tilted up 60 degree on tilting table for 15 minutes to record the change of blood pressure and heart rate, and heart rate variability.
Change of endothelial function (after intervention)
To measure dependent-endothelial moulation by flow-mediated dilatation with Sonosite 180 portable ultrasound.
Change of quality of life (after intervention)
To measure quality of life by Short-form 36 and symptom checklist
Full Information
NCT ID
NCT01721863
First Posted
November 22, 2010
Last Updated
November 2, 2012
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01721863
Brief Title
Effects of Exercise Training in Patients With Permanent Atrial Fibrillation
Official Title
Effects of Exercise Training on Endothelial Function, Heart Rate Variability, Exercise Capacity, and Quality of Life in Patients With Permanent Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Atrial fibrillation (AF) is a common arrhythmia. The proposed patholophysiological mechanisms of AF include abnormal electrical conduction in atrium and sympathovagal imbalance with increased vagal tone. Patients with AF have poor exercise capacity that may contribute to decreased atrial effective refractory period, and decreased cardiac output and heart rate reserve, and may result in poor quality of life. Poor endothelial function had been noted in patients with AF, associated with increased risks of cerebrovascular and cardiovascular disease. Exercise training has been noted to improve exercise capacity and quality of life in patients with AF only in some studies. Endothelial function can be improved by exercise training in patients with cardiovascular disease, but no report in patients with AF. Evidence of exercise training is still needed in patients with AF. The purpose of this study is to investigate the effect of exercise training on
endothelial function
heart rate variability
exercise capacity
quality of life.
Detailed Description
A randomized controlled study was implemented to examine :(1) the effect of interval aerobic exercise training combined with resistance training on endothelial function, heart rate variability (HRV), exercise capacity, and quality of life (QoL); (2) the influential factors related to exercise capacity, and the relationship between exercise capacity and quality of life in patients with permanent atrial fibrillation (AF).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial Fibrillation, Exercise Training, Endothelial Function, Autonomic Nerve Modulation, Exercise Capacity, Quality of Life
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise training
Arm Type
Experimental
Arm Description
Exercise group will undergo progressively aerobic exercise training with 40-85% maximal oxygen consumption for 40 minutes, 3 sessions per week for 12 weeks.
Arm Title
control group
Arm Type
No Intervention
Arm Description
Control group conducted the usual care
Intervention Type
Other
Intervention Name(s)
Exercise training
Other Intervention Name(s)
Aerobic exercise Training
Intervention Description
Exercise group will undergo progressively aerobic exercise training with 40-85% maximal oxygen consumption for 40 minutes, 3 sessions per week for 12 weeks.
Primary Outcome Measure Information:
Title
Change of exercise capacity (after intervention)
Description
To measure maximal oxygen consumption, maximal oxygen pulse, maximal heart rate and blood pressure, cumulated and peak workload by cycle ergometer with Vmax 229 system
Time Frame
At baseline and 12 weeks after intervention
Secondary Outcome Measure Information:
Title
Change of heart rate variability (after intervention)
Description
To record ECG by lead V1 with KENZ 170 on supine position for 1 hour
Time Frame
At baseline and 12 weeks after intervention
Title
Change values of head up tilt test (after intervention)
Description
Subjects were tilted up 60 degree on tilting table for 15 minutes to record the change of blood pressure and heart rate, and heart rate variability.
Time Frame
At baseline and 12 weeks after intervention
Title
Change of endothelial function (after intervention)
Description
To measure dependent-endothelial moulation by flow-mediated dilatation with Sonosite 180 portable ultrasound.
Time Frame
At baseline and 12 weeks after intervention
Title
Change of quality of life (after intervention)
Description
To measure quality of life by Short-form 36 and symptom checklist
Time Frame
At baseline and 12 weeks after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
76 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Permanent atrial fibrillation≥ 1 year aged 40-76 years
Recurrence AF after ablation
Under antiarrhythmia medication control
Exclusion Criteria:
CAD or myocardial infrarction history
NYHA≥ III-IV, or LVEF≤45%
Mitral or aortic valve regurgitation ≥ Gr. II
Mitral valve or aortic valve stenosis
Pacemaker
Cardioversion by ablation
Pulmonary artery hypertension
Any surgery in previous 3 months
Any neurological disorders
Cancer
Severe musculoskeletal disorder
Hyperthyroidism
Premenopausal women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ying-Tai Wu, 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
Learn more about this trial
Effects of Exercise Training in Patients With Permanent Atrial Fibrillation
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