Influence of Yoga in Patients With Neurocardiogenic Syncope (SYNC - YOGA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of Kansas
Sponsor:
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: April 30, 2014
Last verified: April 2014
  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 2014 (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:

    1. Pregnant women
    2. Subjects with untreated or uncontrolled high blood pressure
    3. Subjects with past history of Pnuemothorax.
    4. Subjects with severe cervical spondylitis and cervical, thoracic or lumbar disc prolapse.
    5. Subjects with carotid stenosis
    6. Subjects with history of psychosis (evidence of acute episodes with deep and prolonged meditation) or substance abuse.
    7. Subjects with the history of epilepsy ( evidence of acute episodes with deep and prolonged meditation)
    8. Subjects with glaucoma
    9. Subjects with history of Total Hip Replacement.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: April 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas:
Neurocardiogenic Syncope
Yoga

Additional relevant MeSH terms:
Syncope, Vasovagal
Syncope
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 July 20, 2014