Effects of Exercise Training in Patients With Permanent Atrial Fibrillation

NCT01721863 | Completed Phase 1

• 1 other identifier: 201010032R
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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. 1.endothelial function
2. 2.heart rate variability
3. 3.exercise capacity
4. 4.quality of life.

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation; Exercise Training; Endothelial Function; Autonomic Nerve Modulation; Exercise Capacity; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Change of heart rate variability (after intervention)

  At baseline and 12 weeks after intervention

• Change values of head up tilt test (after intervention)

  At baseline and 12 weeks after intervention

• Change of endothelial function (after intervention)

  At baseline and 12 weeks after intervention

• Change of quality of life (after intervention)

  At baseline and 12 weeks after intervention

Study Arms (2)

Exercise training

EXPERIMENTAL

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

Other: Exercise training

control group

NO INTERVENTION

Control group conducted the usual care

Interventions

Exercise training OTHER

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

Also known as: Aerobic exercise Training

Exercise training

Eligibility Criteria

• Age: 40 Years - 76 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Permanent atrial fibrillation≥ 1 year aged 40-76 years
• Recurrence AF after ablation
• Under antiarrhythmia medication control

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Exercise

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ying-Tai Wu, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2010
• First Posted: November 6, 2012
• Study Start: November 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: November 6, 2012

Record last verified: 2012-10

Locations

TW (1)