Influence of Yoga in Patients With Neurocardiogenic Syncope

Early Phase 1

Completed

• Conditions: Syncope, Vasovagal
• Interventions: Other: Yoga

• Registration Number: NCT01695525
• Lead Sponsor: Dhanunjaya Lakkireddy, MD, FACC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-07-05
• Study First Submitted QC: 2012-09-26
• Study First Posted: 2012-09-28
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-27
• Last Update Posted: 2015-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Yoga	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.

Primary Outcome Measures

Name	Time	Method
Change in frequency of recurrent syncopal spells in patients with Neurocardiogenic syncope (NCS)	Baseline to 1 Year	Differences in the incidence of syncopal symptoms pre and post Yoga.

Secondary Outcome Measures

Name	Time	Method
Change in Heart Health	3 Months, 1 Year

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States