Atrial FibrillationPhase 1NCT01721863
Effects of Exercise Training in Patients With Permanent Atrial Fibrillation
A Phase 1 study testing Exercise training in people with Atrial Fibrillation, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 40 to 76 yearsHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteTaiwan
- Study dates
- Nov 2010to Feb 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 76 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Permanent atrial fibrillation≥ 1 year aged 40-76 years
- Recurrence AF after ablation
- Under antiarrhythmia medication control
Who cannot join
- 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
Show all 13Show fewer
- Pulmonary artery hypertension
- Any surgery in previous 3 months
- Any neurological disorders
- Cancer
- Severe musculoskeletal disorder
- Hyperthyroidism
- Premenopausal women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Exercise Training on Endothelial Function, Heart Rate Variability, Exercise Capacity, and Quality of Life 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
- endothelial function
- heart rate variability
- exercise capacity
- quality of life.
Read the 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).
- Conditions
- Atrial Fibrillation
- Being tested
- Exercise training
- Keywords
- Atrial Fibrillation, Exercise Training, Endothelial Function, Autonomic Nerve Modulation, Exercise Capacity, Quality of Life
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingOther
Also called Aerobic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Exercise training |
| control group | No intervention | Control group conducted the usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At baseline and 12 weeks after intervention
Secondary outcomes (4)
Change of heart rate variability (after intervention)
To record ECG by lead V1 with KENZ 170 on supine position for 1 hour
Measured: At baseline and 12 weeks after intervention
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.
Measured: At baseline and 12 weeks after intervention
Change of endothelial function (after intervention)
To measure dependent-endothelial moulation by flow-mediated dilatation with Sonosite 180 portable ultrasound.
Measured: At baseline and 12 weeks after intervention
Change of quality of life (after intervention)
To measure quality of life by Short-form 36 and symptom checklist
Measured: At baseline and 12 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2012 (estimated)
- Study startNov 2010
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ying-Tai Wu, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01721863
- Sponsor's protocol ID
- 201010032R
- Status last verified
- Oct 2012
- First submitted
- 22 Nov 2010
- Last updated
- 6 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exercise Training on Endothelial Function, Heart Rate Variability, Exercise Capacity, and Quality of Life in Patients With Permanent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT01721863
- Acronym / sponsor ID
- 201010032R
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation, Exercise Training, Endothelial Function, Autonomic Nerve Modulation, Exercise Capacity, Quality of Life
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 6 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- endothelial function
- heart rate variability
- exercise capacity
- quality of life.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise training | Experimental | Other: Exercise trainingExercise 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 | No intervention | –Control group conducted the usual care |
Who may qualify
- Ages
- 40 to 76 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Permanent atrial fibrillation≥ 1 year aged 40-76 years
- Recurrence AF after ablation
- Under antiarrhythmia medication control
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise trainingAlso: Aerobic exercise TrainingExercise 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 |
Primary outcome
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
4 secondary outcomes
Change of heart rate variability (after intervention)
Time frame: At baseline and 12 weeks after intervention
Change values of head up tilt test (after intervention)
Time frame: At baseline and 12 weeks after intervention
Change of endothelial function (after intervention)
Time frame: At baseline and 12 weeks after intervention
Change of quality of life (after intervention)
Time frame: At baseline and 12 weeks after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2012.
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ying-Tai Wu, PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Exercise training in people with Atrial Fibrillation, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of exercise capacity (after intervention) (time frame: At baseline and 12 weeks after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2012.