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

Neurocardiogenic Syncope and the Role That Yoga Plays in People With Autonomic Dysfunction

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.

Study Overview

• Status: Completed
• Conditions: Syncope, Vasovagal
• Intervention / Treatment: Other: Yoga

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in frequency of recurrent syncopal spells in patients with Neurocardiogenic syncope (NCS)	Differences in the incidence of syncopal spells pre and post Yoga.	Baseline to 3 Months
Change in frequency of recurrent syncopal spells in patients with Neurocardiogenic syncope (NCS)	Differences in the incidence of syncopal spells pre and post Yoga.	Baseline to 1 Year
Change in frequency of recurrent syncopal spells in patients with Neurocardiogenic syncope (NCS)	Differences in the incidence of syncopal symptoms pre and post Yoga.	Baseline to 1 Year

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in Heart Health	3 Months, 1 Year

Collaborators and Investigators

• Sponsor: Dhanunjaya Lakkireddy, MD, FACC
• Investigators: Principal Investigator: Dhanunjaya Lakkireddy, MD, FACC, University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: July 5, 2012
• First Submitted That Met QC Criteria: September 26, 2012
• First Posted (Estimate): September 28, 2012

Study Record Updates

• Last Update Posted (Estimate): June 30, 2015
• Last Update Submitted That Met QC Criteria: June 27, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: Yoga; Neurocardiogenic Syncope
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Autonomic Nervous System Diseases; Unconsciousness; Consciousness Disorders; Primary Dysautonomias; Orthostatic Intolerance; Syncope; Syncope, Vasovagal
• Other Study ID Numbers: 12945