Yoga and Rate and Duration of Inappropriate Sinus Tachycardia (IST) Episodes (YOGA STAR)
This study is currently recruiting participants.
Verified January 2013 by University of Kansas
Sponsor:
Dhanunjaya Lakkireddy, MD, FACC
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: January 22, 2013
Last verified: January 2013
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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 2013 (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
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: | January 22, 2013 |
| 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 June 18, 2013