Influence of Yoga in Patients With Neurocardiogenic Syncope (SYNC - YOGA)
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:
NCT01695525
First received: July 5, 2012
Last updated: January 22, 2013
Last verified: January 2013
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Purpose
Syncope is a common problem that many clinicians may encounter in various outpatient settings. Neurocardiogenic syncope (NCS) is a benign condition characterized by a self limited episode of systemic hypotension. Patients are usually managed with education on syncope, anxiety management, and coping skills.
It has been established that practice of Yoga could relieve stress and anxiety. In a different study, they also found that Yoga positively influences cardiovascular function by decreasing the heart rate and blood pressure. The main objective of Yoga is to achieve control over the autonomic nervous system and able to control functions like heart rate, blood pressure and respiratory rate.
Based on the findings that Yoga relieves stress and reduces heart rate, the investigators propose to study if Yoga can decrease the frequency of NCS and also reduce the symptoms associated with these episodes.
| Condition | Intervention |
|---|---|
|
Syncope, Vasovagal |
Other: Yoga |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Neurocardiogenic Syncope and the Role That Yoga Plays in People With Autonomic Dysfunction |
Resource links provided by NLM:
Further study details as provided by University of Kansas:
Primary Outcome Measures:
- Change in frequency of recurrent syncopal spells in patients with Neurocardiogenic syncope (NCS) [ Time Frame: Baseline to 3 Months ] [ Designated as safety issue: No ]Differences in the incidence of syncopal spells pre and post Yoga.
- Change in frequency of recurrent syncopal spells in patients with Neurocardiogenic syncope (NCS) [ Time Frame: Baseline to 1 Year ] [ Designated as safety issue: No ]Differences in the incidence of syncopal spells pre and post Yoga.
- Change in frequency of recurrent syncopal spells in patients with Neurocardiogenic syncope (NCS) [ Time Frame: Baseline to 1 Year ] [ Designated as safety issue: No ]Differences in the incidence of syncopal symptoms pre and post Yoga.
Secondary Outcome Measures:
- Change in Heart Health [ Time Frame: 3 Months, 1 Year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | January 2015 |
| 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 times per week at a minimum, and daily at a maximum. Participants will receive training in different Yoga techniques including breathing exercises, postures and meditation. Participants will be asked to practice 1 hour Yoga sessions comprised of breathing exercises, postures and meditation.
|
Other: Yoga
Includes breathing exercises, postures, and meditation. Participant practices yoga at their home a minimum of 3 times per week for 1 hour per time. Participation can last for up to 1 year.
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of recurrent Neurocardiogenic syncope
- At least one episode of syncope or pre-syncopal event in the last 3 months prior to enrollment
Exclusion Criteria:
- Previously established diagnosis of any psychiatric illness.
- Previous history of Coronary Artery Disease, myocardial infarction, congestive heart failure, carotid sinus hypersensitivity
- Established diagnosis of tachy and/or brady arrhythmias, except cardioinhibiotry neurocardiogenic syncope.
- History of pacemaker, ICD or CRT-D implantation.
Other conditions where Yoga should be avoided are:
- Pregnant women
- Subjects with untreated or uncontrolled high blood pressure
- Subjects with past history of Pnuemothorax.
- Subjects with severe cervical spondylitis and cervical, thoracic or lumbar disc prolapse.
- Subjects with carotid stenosis
- Subjects with history of psychosis (evidence of acute episodes with deep and prolonged meditation) or substance abuse.
- Subjects with the history of epilepsy ( evidence of acute episodes with deep and prolonged meditation)
- Subjects with glaucoma
- Subjects with history of Total Hip Replacement.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01695525
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 of Medicine, University of Kansas Medical Center Research Institute |
| ClinicalTrials.gov Identifier: | NCT01695525 History of Changes |
| Other Study ID Numbers: | 12945 |
| Study First Received: | July 5, 2012 |
| Last Updated: | January 22, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Kansas:
|
Neurocardiogenic Syncope Yoga |
Additional relevant MeSH terms:
|
Syncope Syncope, Vasovagal Unconsciousness Consciousness Disorders Neurobehavioral Manifestations Neurologic Manifestations |
Nervous System Diseases Signs and Symptoms Orthostatic Intolerance Primary Dysautonomias Autonomic Nervous System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013