Clinical trial NCT01721863: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation
Exercise Training
Endothelial Function
Autonomic Nerve Modulation
Exercise Capacity
Quality of Life
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2012-11-06
Enrollment: 58
Sex: ALL
Minimum age (years): 40
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

1. endothelial function
2. heart rate variability
3. exercise capacity
4. 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).

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

Primary outcomes:
measure: Change of exercise capacity (after intervention)
timeFrame: At baseline and 12 weeks after intervention
Secondary outcomes:
measure: Change of heart rate variability (after intervention)
timeFrame: At baseline and 12 weeks after intervention
measure: Change values of head up tilt test (after intervention)
timeFrame: At baseline and 12 weeks after intervention
measure: Change of endothelial function (after intervention)
timeFrame: At baseline and 12 weeks after intervention
measure: Change of quality of life (after intervention)
timeFrame: At baseline and 12 weeks after intervention
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Ying-Tai Wu, PhD
role: PRINCIPAL_INVESTIGATOR
References: