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Yoga and Rate and Duration of Inappropriate Sinus Tachycardia (IST) Episodes (YOGA STAR)

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ClinicalTrials.gov Identifier: NCT01695538
Recruitment Status : Withdrawn
First Posted : September 28, 2012
Last Update Posted : November 16, 2015
Information provided by (Responsible Party):

Study Description
Brief 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. 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.

Condition or disease Intervention/treatment
Inappropriate Sinus Tachycardia Other: Yoga

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Yoga on Arrhythmia Burden and Quality of Life in Patients With Inappropriate Sinus Tachycardia
Study Start Date : December 2011
Primary Completion Date : November 2015
Study Completion Date : November 2015
Arms and Interventions

Arm Intervention/treatment
Experimental: Yoga
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.
Other: Yoga
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.

Outcome Measures

Primary Outcome Measures :
  1. Determine if Yoga affects the rate and duration of IST episodes [ Time Frame: Change from Baseline to 3 Months ]
  2. Determine if Yoga affects the rate and duration of IST episodes [ Time Frame: Change from Baseline to 1 Year ]

Secondary Outcome Measures :
  1. 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 ]
  2. Change in Quality of Life [ Time Frame: 3 Months, 1 Year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients diagnosed with inappropriate sinus tachycardia

Exclusion Criteria:

  • 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
  • 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01695538

United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
Dhanunjaya Lakkireddy, MD, FACC
Principal Investigator: Dhanunjaya Lakkireddy, MD, FACC University of Kansas Medical Center
More Information

Responsible Party: Dhanunjaya Lakkireddy, MD, FACC, Professor, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT01695538     History of Changes
Other Study ID Numbers: 12946
First Posted: September 28, 2012    Key Record Dates
Last Update Posted: November 16, 2015
Last Verified: November 2015

Keywords provided by Dhanunjaya Lakkireddy, MD, FACC, University of Kansas Medical Center Research Institute:
atrial tachycardia

Additional relevant MeSH terms:
Tachycardia, Sinus
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Tachycardia, Supraventricular