Yoga and Rate and Duration of Inappropriate Sinus Tachycardia (IST) Episodes
YOGA STAR
The Effect of Yoga on Arrhythmia Burden and Quality of Life in Patients With Inappropriate Sinus Tachycardia
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Dec 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 5, 2012
CompletedFirst Posted
Study publicly available on registry
September 28, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedNovember 16, 2015
November 1, 2015
3.9 years
July 5, 2012
November 13, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Determine if Yoga affects the rate and duration of IST episodes
Change from Baseline to 3 Months
Determine if Yoga affects the rate and duration of IST episodes
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
3 Months, 1 Year
Change in Quality of Life
3 Months, 1 Year
Study Arms (1)
Yoga
EXPERIMENTALParticipants will be asked to practice yoga 3 days per week, at a minimum and encouraged to practice 7 days per week, for 1 year.
Interventions
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 Criteria
You may qualify if:
- Patients diagnosed with inappropriate sinus tachycardia
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dhanunjaya Lakkireddy, MD, FACC
University of Kansas Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 5, 2012
First Posted
September 28, 2012
Study Start
December 1, 2011
Primary Completion
November 1, 2015
Study Completion
November 1, 2015
Last Updated
November 16, 2015
Record last verified: 2015-11