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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of Kansas
Sponsor:
Information provided by (Responsible Party):
Dhanunjaya Lakkireddy, MD, FACC, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT01695538
First received: July 5, 2012
Last updated: April 30, 2014
Last verified: April 2014
  Purpose

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 Intervention
Inappropriate Sinus Tachycardia
Other: Yoga

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Yoga on Arrhythmia Burden and Quality of Life in Patients With Inappropriate Sinus Tachycardia

Resource links provided by NLM:


Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • Determine if Yoga affects the rate and duration of IST episodes [ Time Frame: Change from Baseline to 3 Months ] [ Designated as safety issue: No ]
  • Determine if Yoga affects the rate and duration of IST episodes [ Time Frame: Change from Baseline to 1 Year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Change in Quality of Life [ Time Frame: 3 Months, 1 Year ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: December 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01695538

Contacts
Contact: Donita Atkins, RN (913) 588-9714 datkins2@kumc.edu

Locations
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Donita Atkins, RN    913-588-9714    datkins2@kumc.edu   
Sponsors and Collaborators
Dhanunjaya Lakkireddy, MD, FACC
Investigators
Principal Investigator: Dhanunjaya Lakkireddy, MD, FACC University of Kansas
  More Information

No publications provided

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
Study First Received: July 5, 2012
Last Updated: April 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas:
Yoga
atrial tachycardia

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

ClinicalTrials.gov processed this record on July 24, 2014