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

November 13, 2015 updated by: Dhanunjaya Lakkireddy, MD, FACC

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determine if Yoga affects the rate and duration of IST episodes
Time Frame: Change from Baseline to 3 Months
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
Change from Baseline to 1 Year

Secondary Outcome Measures

Outcome Measure
Time Frame
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
3 Months, 1 Year
Change in Quality of Life
Time Frame: 3 Months, 1 Year
3 Months, 1 Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dhanunjaya Lakkireddy, MD, FACC

Investigators

  • Principal Investigator: Dhanunjaya Lakkireddy, MD, FACC, University of Kansas Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

July 5, 2012

First Submitted That Met QC Criteria

September 26, 2012

First Posted (Estimate)

September 28, 2012

Study Record Updates

Last Update Posted (Estimate)

November 16, 2015

Last Update Submitted That Met QC Criteria

November 13, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12946

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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