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NCT Number: NCT01721863

Effects of Exercise Training in Patients With Permanent Atrial Fibrillation

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.

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Key information

Conditions

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

Age range

40 year–76 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

National Taiwan University Hospital

Taipei, Taiwan

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Aerobic exercise Training

Primary outcomes

  1. Change of exercise capacity (after intervention)

    Time frame: At baseline and 12 weeks 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 outcomes

  1. Change of heart rate variability (after intervention)

    Time frame: At baseline and 12 weeks after intervention

    To record ECG by lead V1 with KENZ 170 on supine position for 1 hour

  2. Change values of head up tilt test (after intervention)

    Time frame: At baseline and 12 weeks 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.

  3. Change of endothelial function (after intervention)

    Time frame: At baseline and 12 weeks after intervention

    To measure dependent-endothelial moulation by flow-mediated dilatation with Sonosite 180 portable ultrasound.

  4. Change of quality of life (after intervention)

    Time frame: At baseline and 12 weeks after intervention

    To measure quality of life by Short-form 36 and symptom checklist

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Nov 6, 2012
Registry last updated
Nov 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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