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Effects of Exercise Training in Patients With Permanent Atrial Fibrillation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01721863
First received: November 22, 2010
Last updated: November 2, 2012
Last verified: October 2012
History of Changes
  Purpose

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.

Condition Intervention Phase
Atrial Fibrillation
 Other: Exercise training
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Exercise Training on Endothelial Function, Heart Rate Variability, Exercise Capacity, and Quality of Life in Patients With Permanent Atrial Fibrillation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Change of exercise capacity (after intervention) [ Time Frame: At baseline and 12 weeks after intervention ] [ Designated as safety issue: No ]
    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) [ Time Frame: At baseline and 12 weeks after intervention ] [ Designated as safety issue: No ]
    To record ECG by lead V1 with KENZ 170 on supine position for 1 hour

  • Change values of head up tilt test (after intervention) [ Time Frame: At baseline and 12 weeks after intervention ] [ Designated as safety issue: No ]
    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) [ Time Frame: At baseline and 12 weeks after intervention ] [ Designated as safety issue: No ]
    To measure dependent-endothelial moulation by flow-mediated dilatation with Sonosite 180 portable ultrasound.

  • Change of quality of life (after intervention) [ Time Frame: At baseline and 12 weeks after intervention ] [ Designated as safety issue: No ]
    To measure quality of life by Short-form 36 and symptom checklist


Enrollment: 58
Study Start Date: November 2010
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
 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.
Other Name: Aerobic exercise Training
No Intervention: control group
Control group conducted the usual care

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

Ages Eligible for Study:   40 Years to 76 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01721863

Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Ying-Tai Wu, PhD National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01721863     History of Changes
Other Study ID Numbers: 201010032R
Study First Received: November 22, 2010
Last Updated: November 2, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Atrial Fibrillation
Exercise Training
Endothelial Function
 Autonomic Nerve Modulation
Exercise Capacity
Quality of Life

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013