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Effects of Exercise Training in Patients With Permanent Atrial Fibrillation

NCT ID: NCT01721863

Last Updated: 2012-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2012-02-29

Brief Summary

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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

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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).

Conditions

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Atrial Fibrillation

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Exercise training

Intervention Type 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.

control group

Control group conducted the usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Aerobic exercise Training

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

76 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ying-Tai Wu, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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201010032R

Identifier Type: -

Identifier Source: org_study_id