SYNC - YOGA: Influence of Yoga in Patients With Neurocardiogenic Syncope

Sponsor

Dhanunjaya Lakkireddy, MD, FACC (Other)

Overall Status

Completed

CT.gov ID

NCT01695525

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Syncope, Vasovagal	Other: Yoga	Early Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

8 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2012

Actual Primary Completion Date :

Mar 1, 2015

Actual Study Completion Date :

Mar 1, 2015

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change in frequency of recurrent syncopal spells in patients with Neurocardiogenic syncope (NCS) [Baseline to 3 Months]
Differences in the incidence of syncopal spells pre and post Yoga.
Change in frequency of recurrent syncopal spells in patients with Neurocardiogenic syncope (NCS) [Baseline to 1 Year]
Differences in the incidence of syncopal spells pre and post Yoga.
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

Change in Heart Health [3 Months, 1 Year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	University of Kansas Medical Center	Kansas City	Kansas	United States	66160

Sponsors and Collaborators

Dhanunjaya Lakkireddy, MD, FACC

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dhanunjaya Lakkireddy, MD, FACC, Professor of Medicine, University of Kansas Medical Center

ClinicalTrials.gov Identifier:

NCT01695525

Other Study ID Numbers:

12945

First Posted:

Sep 28, 2012

Last Update Posted:

Jun 30, 2015

Last Verified:

Jun 1, 2015

Keywords provided by Dhanunjaya Lakkireddy, MD, FACC, Professor of Medicine, University of Kansas Medical Center

Neurocardiogenic Syncope

Yoga

Additional relevant MeSH terms:

Syncope

Syncope, Vasovagal

Study Results

No Results Posted as of Jun 30, 2015