Atrial FibrillationNCT00798356
Yoga on Arrhythmia Burden and Quality of Life in Paroxysmal Atrial Fibrillation
A study testing Yoga training in people with Atrial Fibrillation, run by Dhanunjaya Lakkireddy, MD, FACC at 1 site in United States.
Trial summary
Studies in the past have shown that yoga could relieve stress which is the most common trigger for recurrent episodes of atrial fibrillation. Breathing exercises in yoga are found to influence the autonomic nervous system (particularly parasympathetic) and thus reduce palpitations. Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Yoga training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Jan 2012
- 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 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with paroxysmal atrial fibrillation ages 25-80
Who cannot join
- Advanced malignancy or severe co-morbid conditions such as severe heart failure and with life expectancy less than 1 year
- Pregnant women
- Unmedicated or uncontrolled high blood pressure
- A past history of pneumothorax
- Severe cervical spondylitis and cervical, thoracic or lumbar disc prolapse
- Carotid stenosis
Show all 12Show fewer
- History of psychosis or substance abuse
- History of epilepsy
- Glaucoma
- History of total hip replacement
- Ablation within 3 months of the start date of study
- Patients who have not seen a cardiovascular physician in the last year
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: The Effect of Yoga on Arrhythmia Burden and Quality of Life in Patients With Paroxysmal Atrial Fibrillation
Studies in the past have shown that yoga could relieve stress which is the most common trigger for recurrent episodes of atrial fibrillation. Breathing exercises in yoga are found to influence the autonomic nervous system (particularly parasympathetic) and thus reduce palpitations. This study hypothesizes that patients with atrial fibrillation might benefit by practicing yoga. Yoga may also help to better control heart rate and rhythm when used in combination with usual medical management.
- Conditions
- Atrial Fibrillation
- Being tested
- Yoga training
- Keywords
- atrial fibrillation, yoga
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga trainingOther
Yoga training for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Yoga training Receives: Other: Yoga training |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency and duration of atrial fibrillation episodes
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dhanunjaya Lakkireddy, MD, FACC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dhanunjaya Lakkireddy, MD, FACC, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00798356
- Sponsor's protocol ID
- 11067
- Status last verified
- Jun 2012
- First submitted
- 25 Nov 2008
- Last updated
- 14 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Lakkireddy D, Atkins D, Pillarisetti J, Ryschon K, Bommana S, Drisko J, Vanga S, Dawn B. Effect of yoga on arrhythmia burden, anxiety, depression, and quality of life in paroxysmal atrial fibrillation: the YOGA My Heart Study. J Am Coll Cardiol. 2013 Mar 19;61(11):1177-82. doi: 10.1016/j.jacc.2012.11.060. Epub 2013 Jan 30.
PubMed 23375926
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Yoga on Arrhythmia Burden and Quality of Life in Patients With Paroxysmal Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT00798356
- Acronym / sponsor ID
- 11067
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, yoga
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Dhanunjaya Lakkireddy, MD, FACCUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 26 Nov 2008 (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.
Studies in the past have shown that yoga could relieve stress which is the most common trigger for recurrent episodes of atrial fibrillation. Breathing exercises in yoga are found to influence the autonomic nervous system (particularly parasympathetic) and thus reduce palpitations. This study hypothesizes that patients with atrial fibrillation might benefit by practicing yoga. Yoga may also help to better control heart rate and rhythm when used in combination with usual medical management.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Other: Yoga trainingYoga training |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed with paroxysmal atrial fibrillation ages 25-80
Key exclusion criteria (12 listed)
- Advanced malignancy or severe co-morbid conditions such as severe heart failure and with life expectancy less than 1 year
- Pregnant women
- Unmedicated or uncontrolled high blood pressure
- A past history of pneumothorax
- Severe cervical spondylitis and cervical, thoracic or lumbar disc prolapse
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 |
|---|---|---|
| Yoga trainingYoga training for 12 weeks | Other | 1 |
Primary outcome
frequency and duration of atrial fibrillation episodes
Time frame: 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 14 Jun 2012.
- Derived from this study: PubMed 23375926Lakkireddy D, Atkins D, Pillarisetti J, Ryschon K, Bommana S, Drisko J, Vanga S, Dawn B. Effect of yoga on arrhythmia burden, anxiety, depression, and quality of life in paroxysmal atrial fibrillation: the YOGA My Heart Study. J Am Coll Cardiol. 2013 Mar 19;61(11):1177-82. doi: 10.1016/j.jacc.2012.11.060. Epub 2013 Jan 30.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga training in people with Atrial Fibrillation, run by Dhanunjaya Lakkireddy, MD, FACC at 1 site in United States.
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 12 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 14 Jun 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 United States. 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?
frequency and duration of atrial fibrillation episodes (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00798356, which also lists 1 linked publication.
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 14 Jun 2012.