Influence of Yoga in Patients With Neurocardiogenic Syncope

Syncope, Vasovagal Clinical Trial

— SYNC - YOGA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01695525
• Other study ID #: 12945
• Status: Completed
• Phase: Phase 0
• First received: July 5, 2012
• Last updated: June 27, 2015
• Start date: June 2012
• Est. completion date: March 2015

Study information

• Verified date: June 2015
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Syncope
• Syncope, Vasovagal

Intervention

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.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Dhanunjaya Lakkireddy, MD, FACC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Change in Heart Health		3 Months, 1 Year	No