Effects of Exercise Training in Patients With Permanent Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

Effects of Exercise Training on Endothelial Function, Heart Rate Variability, Exercise Capacity, and Quality of Life in Patients With Permanent Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01721863
• Other study ID #: 201010032R
• Status: Completed
• Phase: Phase 1
• First received: November 22, 2010
• Last updated: November 2, 2012
• Start date: November 2010
• Est. completion date: February 2012

Study information

• Verified date: October 2012
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 76 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Other:
• Exercise training
Exercise group will undergo progressively aerobic exercise training with 40-85% maximal oxygen consumption for 40 minutes, 3 sessions per week for 12 weeks.

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	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	At baseline and 12 weeks after intervention	No
Secondary	Change of heart rate variability (after intervention)	To record ECG by lead V1 with KENZ 170 on supine position for 1 hour	At baseline and 12 weeks after intervention	No
Secondary	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.	At baseline and 12 weeks after intervention	No
Secondary	Change of endothelial function (after intervention)	To measure dependent-endothelial moulation by flow-mediated dilatation with Sonosite 180 portable ultrasound.	At baseline and 12 weeks after intervention	No
Secondary	Change of quality of life (after intervention)	To measure quality of life by Short-form 36 and symptom checklist	At baseline and 12 weeks after intervention	No