Inappropriate Sinus TachycardiaYOGA STARNCT01695538
Yoga and Rate and Duration of Inappropriate Sinus Tachycardia (IST) Episodes
A study testing Yoga in people with Inappropriate Sinus Tachycardia, run by Dhanunjaya Lakkireddy, MD, FACC at 1 site in United States.
Trial summary
Inappropriate sinus tachycardia (IST) is an uncommon form of atrial tachycardia. The term "inappropriate" in medicine is commonly defined as a heart rate greater than 100 beats per minute at rest or with minimal physiological challenge. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Inappropriate Sinus Tachycardia
- What is being tested?
- Yoga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Nov 2015
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients diagnosed with inappropriate sinus tachycardia
Who cannot join
- Advanced malignancy or severe co-morbidities such as severe heart failure and with life expectancy less than 1 year
- Pregnant women
- Patients with unmedicated or uncontrolled high blood pressure
- Patients with past history of Pnuemothorax
- Patients with severe cervical spondylitis and cervical, thoracic, or lumbar disc prolapse
- Patients with carotid stenosis
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- Patients with history of psychosis (evidence of acute episodes with deep and prolonged meditation) or substance abuse
- Patients with history of epilepsy (evidence of acute episodes with deep and prolonged medication)
- Patients with glaucoma
- Patients with history of Total Hip Replacement
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 Inappropriate Sinus Tachycardia
Inappropriate sinus tachycardia (IST) is an uncommon form of atrial tachycardia. The term "inappropriate" in medicine is commonly defined as a heart rate greater than 100 beats per minute at rest or with minimal physiological challenge. IST is characterized by an increased resting heart rate with an exaggerated response to exercise or stress.
Yoga has been used extensively around the world as an alternative medicine approach in treating numerous chronic and debilitating diseases. Studies have been conducted in various countries to determine the benefits of Yoga as therapy for these chronic diseases. Several studies have confirmed that yoga can reduce anxiety and regulate the stress response.
Studies in the past have shown that Yoga relieves stress, one of the most common triggers for the arrhythmia and increased heart rate in IST. Based on past studies we hypothesize that patients with IST might benefit by practicing yoga. Yoga may also help in better rate and rhythm control with yoga when employed in combination with usual medical arrangement.
- Conditions
- Inappropriate Sinus Tachycardia
- Being tested
- Yoga
- Keywords
- Yoga, atrial tachycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaOther
The subjects will be asked to practice Yoga poses at least 3 times a week at home, although daily Yoga will be encouraged. Participants will be trained in breathing exercises, postures and meditation. Each time they practice yoga will be for 1 hour and include breathing exercises, postures and meditation.
| Study group | Role | What they receive |
|---|---|---|
| Yoga | Experimental | Participants will be asked to practice yoga 3 days per week, at a minimum and encouraged to practice 7 days per week, for 1 year. Receives: Other: Yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine if Yoga affects the rate and duration of IST episodes
Measured: Change from Baseline to 3 Months
Determine if Yoga affects the rate and duration of IST episodes
Measured: Change from Baseline to 1 Year
Secondary outcomes (2)
Effect yoga has on resting heart rate or occurrence of IST episodes in patients that have undergone treatment with medications and/or ablation procedures
Measured: 3 Months, 1 Year
Change in Quality of Life
Measured: 3 Months, 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2012 (estimated)
- Study startDec 2011
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inappropriate Sinus TachycardiaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 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
- Investigators
- Dhanunjaya Lakkireddy, MD, FACC, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01695538
- Sponsor's protocol ID
- 12946
- Acronym
- YOGA STAR
- Status last verified
- Nov 2015
- First submitted
- 5 Jul 2012
- Last updated
- 16 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2015. 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 Inappropriate Sinus Tachycardia
- ClinicalTrials.gov ID
- NCT01695538
- Acronym / sponsor ID
- YOGA STAR / 12946
- Conditions
- Inappropriate Sinus Tachycardia
- Keywords
- Yoga, atrial tachycardia
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Dhanunjaya Lakkireddy, MD, FACCUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 28 Sep 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.
Inappropriate sinus tachycardia (IST) is an uncommon form of atrial tachycardia. The term "inappropriate" in medicine is commonly defined as a heart rate greater than 100 beats per minute at rest or with minimal physiological challenge. IST is characterized by an increased resting heart rate with an exaggerated response to exercise or stress.
Yoga has been used extensively around the world as an alternative medicine approach in treating numerous chronic and debilitating diseases. Studies have been conducted in various countries to determine the benefits of Yoga as therapy for these chronic diseases. Several studies have confirmed that yoga can reduce anxiety and regulate the stress response.
Studies in the past have shown that Yoga relieves stress, one of the most common triggers for the arrhythmia and increased heart rate in IST. Based on past studies we hypothesize that patients with IST might benefit by practicing yoga. Yoga may also help in better rate and rhythm control with yoga when employed in combination with usual medical arrangement.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Yoga | Experimental | Other: YogaParticipants will be asked to practice yoga 3 days per week, at a minimum and encouraged to practice 7 days per week, for 1 year. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients diagnosed with inappropriate sinus tachycardia
Key exclusion criteria (10 listed)
- Advanced malignancy or severe co-morbidities such as severe heart failure and with life expectancy less than 1 year
- Pregnant women
- Patients with unmedicated or uncontrolled high blood pressure
- Patients with past history of Pnuemothorax
- Patients with 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 |
|---|---|---|
| YogaThe subjects will be asked to practice Yoga poses at least 3 times a week at home, although daily Yoga will be encouraged. Participants will be trained in breathing exercises, postures and meditation. Each time they practice yoga will be for 1 hour and include breathing exercises, postures and meditation. | Other | Yoga |
Primary outcome
Determine if Yoga affects the rate and duration of IST episodes
Time frame: Change from Baseline to 3 Months
Determine if Yoga affects the rate and duration of IST episodes
Time frame: Change from Baseline to 1 Year
2 secondary outcomes
Effect yoga has on resting heart rate or occurrence of IST episodes in patients that have undergone treatment with medications and/or ablation procedures
Time frame: 3 Months, 1 Year
Change in Quality of Life
Time frame: 3 Months, 1 Year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2015.
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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.
Dhanunjaya Lakkireddy, MD, FACC principal investigator
University of Kansas Medical Center
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 in people with Inappropriate Sinus Tachycardia, 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 10 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: withdrawn, as of the sponsor's last update on 16 Nov 2015. 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 was withdrawn before enrolling participants, so there are no results.
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?
Determine if Yoga affects the rate and duration of IST episodes (time frame: Change from Baseline to 3 Months). The study lists 2 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 16 Nov 2015.