Atrial FibrillationNCT01367197
Study of the Effect of Exercise Training on Patients in Atrial Fibrillation
A study testing exercise training in people with Atrial Fibrillation, run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.
Trial summary
PURPOSE Physical exercise is beneficial for patients with ischemic heart disease and chronic heart failure, while little is known about the effect in atrial fibrillation (AF). The investigators studied the effect of physical exercise on cardiac output (CO), max. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2009to Jun 2011
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult subjects in permanent atrial fibrillation, willing to participate in a 12 weeks training program and able to give informed consent to participation were eligible for the study.
Who cannot join
- Subjects with severe refractory hypertension
- previous heart valve surgery, moderate to severe COPD
- restrictive lung disease, moderate to severe asthma
- pregnant or lactating subjects
- patients with a very low life expectancy
- patients who were unable to exercise or comply with the study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised Study of the Effect of Exercise Training on Patients in Atrial Fibrillation
PURPOSE Physical exercise is beneficial for patients with ischemic heart disease and chronic heart failure, while little is known about the effect in atrial fibrillation (AF). The investigators studied the effect of physical exercise on cardiac output (CO), max. exercise capacity, biomarkers and quality of life (Qol) in patients with AF in a randomised study of physical exercise training three times weekly for twelve weeks.
HYPOTHESIS Exercise training improves cardiac output (CO), max. exercise capacity, biomarkers and quality of life (Qol) in patients with AF.
Read more
METHODS Assessment of exercise capacity, CO, Qol, body composition, six minute walk test and muscular strength was performed before and after 12 weeks.
Resting echocardiography was done at baseline. CO was measured using impedance cardiography at rest and during maximal exercise testing on an ergometer bicycle. Body composition, muscular strength and six minutes walking capacity were measured before and after the training period. Qol was evaluated by the use of the standardized validated questionnaires Short Form 36 (SF-36) and the Minnesota Living with Heart Failure Questionnaire (MLHF-Q).
Training consisted of aerobic exercise at 70 percent of max. capacity estimated by Borg-scale.
- Conditions
- Atrial Fibrillation
- Being tested
- exercise training
- Keywords
- exercise training, atrial fibrillation
- 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 trainingBehavioural
group based exercise training
| Study group | Role | What they receive |
|---|---|---|
| No intervention | No intervention | Observation only |
| Exercise training group | Experimental | Group exercise training, three times weekly high-intensity Receives: Behavioral: exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiac output
participants will be followed for the duration of the intervention, an average of 12 weeks
Measured: participants will be followed for the duration of the intervention, an average of 12 weeks
Quality of life
participants will be followed for the duration of the intervention, an average of 12 weeks
Measured: participants will be followed for the duration of the intervention, an average of 12 weeks
exercise capacity
participants will be followed for the duration of the intervention, an average of 12 weeks
Measured: participants will be followed for the duration of the intervention, an average of 12 weeks
Secondary outcomes (3)
muscle strength
participants will be followed for the duration of the intervention, an average of 12 weeks
Measured: participants will be followed for the duration of the intervention, an average of 12 weeks
biomarkers ANB, BNP
participants will be followed for the duration of the intervention, an average of 12 weeks
Measured: participants will be followed for the duration of the intervention, an average of 12 weeks
Body composition DEXA-scan
participants will be followed for the duration of the intervention, an average of 12 weeks
Measured: participants will be followed for the duration of the intervention, an average of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2011 (estimated)
- Study startJan 2009
- Primary completionDec 2010
- Study completionJun 2011
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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Hvidovre
- Sponsor type
- University, hospital or other
- Collaborators
- Hvidovre University Hospital, University of Copenhagen
- Investigators
- Philip S Osbak, MD, Principal investigator, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01367197
- Sponsor's protocol ID
- 22300240
- Status last verified
- Jun 2011
- First submitted
- 1 Jun 2011
- Last updated
- 7 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Study of the Effect of Exercise Training on Patients in Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT01367197
- Acronym / sponsor ID
- 22300240
- Conditions
- Atrial Fibrillation
- Keywords
- exercise training, atrial fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, HvidovreUniversity, hospital or other
- Collaborators
- Hvidovre University Hospital, University of Copenhagen
- Study start
- Jan 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 7 Jun 2011 (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.
PURPOSE Physical exercise is beneficial for patients with ischemic heart disease and chronic heart failure, while little is known about the effect in atrial fibrillation (AF). The investigators studied the effect of physical exercise on cardiac output (CO), max. exercise capacity, biomarkers and quality of life (Qol) in patients with AF in a randomised study of physical exercise training three times weekly for twelve weeks.
HYPOTHESIS Exercise training improves cardiac output (CO), max. exercise capacity, biomarkers and quality of life (Qol) in patients with AF.
METHODS Assessment of exercise capacity, CO, Qol, body composition, six minute walk test and muscular strength was performed before and after 12 weeks.
Resting echocardiography was done at baseline. CO was measured using impedance cardiography at rest and during maximal exercise testing on an ergometer bicycle. Body composition, muscular strength and six minutes walking capacity were measured before and after the training period. Qol was evaluated by the use of the standardized validated questionnaires Short Form 36 (SF-36) and the Minnesota Living with Heart Failure Questionnaire (MLHF-Q).
Training consisted of aerobic exercise at 70 percent of max. capacity estimated by Borg-scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No intervention | No intervention | –Observation only |
| Exercise training group | Experimental | Behavioral: exercise trainingGroup exercise training, three times weekly high-intensity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult subjects in permanent atrial fibrillation, willing to participate in a 12 weeks training program and able to give informed consent to participation were eligible for the study.
Key exclusion criteria (6 listed)
- Subjects with severe refractory hypertension
- previous heart valve surgery, moderate to severe COPD
- restrictive lung disease, moderate to severe asthma
- pregnant or lactating subjects
- patients with a very low life expectancy
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 traininggroup based exercise training | Behavioural | Exercise training group |
Primary outcome
cardiac output
Time frame: participants will be followed for the duration of the intervention, an average of 12 weeks
participants will be followed for the duration of the intervention, an average of 12 weeks
Quality of life
Time frame: participants will be followed for the duration of the intervention, an average of 12 weeks
participants will be followed for the duration of the intervention, an average of 12 weeks
exercise capacity
Time frame: participants will be followed for the duration of the intervention, an average of 12 weeks
participants will be followed for the duration of the intervention, an average of 12 weeks
3 secondary outcomes
muscle strength
Time frame: participants will be followed for the duration of the intervention, an average of 12 weeks
biomarkers ANB, BNP
Time frame: participants will be followed for the duration of the intervention, an average of 12 weeks
Body composition DEXA-scan
Time frame: participants will be followed for the duration of the intervention, an average of 12 weeks
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 7 Jun 2011.
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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.
Philip S Osbak, MD principal investigator
Hvidovre University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise training in people with Atrial Fibrillation, run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.
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 1 inclusion and 6 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 7 Jun 2011. 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 Denmark. 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.
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?
cardiac output (time frame: participants will be followed for the duration of the intervention, an average of 12 weeks). The study lists 3 primary outcomes in all. 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 7 Jun 2011.