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

Inappropriate Sinus Tachycardia Clinical Trial

— YOGA STAR  

Official title:

The Effect of Yoga on Arrhythmia Burden and Quality of Life in Patients With Inappropriate Sinus Tachycardia

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01695538
• Other study ID #: 12946
• Status: Withdrawn
• Phase: N/A
• First received: July 5, 2012
• Last updated: November 13, 2015
• Start date: December 2011
• Est. completion date: November 2015

Study information

• Verified date: November 2015
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Inappropriate Sinus Tachycardia
• Tachycardia
• Tachycardia, Sinus

Intervention

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.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Dhanunjaya Lakkireddy, MD, FACC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine if Yoga affects the rate and duration of IST episodes		Change from Baseline to 3 Months	No
Primary	Determine if Yoga affects the rate and duration of IST episodes		Change from Baseline to 1 Year	No
Secondary	Effect yoga has on resting heart rate or occurrence of IST episodes in patients that have undergone treatment with medications and/or ablation procedures		3 Months, 1 Year	No
Secondary	Change in Quality of Life		3 Months, 1 Year	No