Yoga and Rate and Duration of Inappropriate Sinus Tachycardia (IST) Episodes (YOGA STAR)
Primary Purpose
Inappropriate Sinus Tachycardia
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Yoga
Sponsored by
About this trial
This is an interventional treatment trial for Inappropriate Sinus Tachycardia focused on measuring Yoga, atrial tachycardia
Eligibility 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
Sites / Locations
- University of Kansas Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Yoga
Arm Description
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.
Outcomes
Primary Outcome Measures
Determine if Yoga affects the rate and duration of IST episodes
Determine if Yoga affects the rate and duration of IST episodes
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
Change in Quality of Life
Full Information
NCT ID
NCT01695538
First Posted
July 5, 2012
Last Updated
November 13, 2015
Sponsor
Dhanunjaya Lakkireddy, MD, FACC
1. Study Identification
Unique Protocol Identification Number
NCT01695538
Brief Title
Yoga and Rate and Duration of Inappropriate Sinus Tachycardia (IST) Episodes
Acronym
YOGA STAR
Official Title
The Effect of Yoga on Arrhythmia Burden and Quality of Life in Patients With Inappropriate Sinus Tachycardia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Withdrawn
Study Start Date
December 2011 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dhanunjaya Lakkireddy, MD, FACC
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inappropriate Sinus Tachycardia
Keywords
Yoga, atrial tachycardia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Yoga
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Yoga
Intervention Description
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.
Primary Outcome Measure Information:
Title
Determine if Yoga affects the rate and duration of IST episodes
Time Frame
Change from Baseline to 3 Months
Title
Determine if Yoga affects the rate and duration of IST episodes
Time Frame
Change from Baseline to 1 Year
Secondary Outcome Measure Information:
Title
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
Title
Change in Quality of Life
Time Frame
3 Months, 1 Year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dhanunjaya Lakkireddy, MD, FACC
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
12. IPD Sharing Statement
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Yoga and Rate and Duration of Inappropriate Sinus Tachycardia (IST) Episodes
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