Influence of Yoga in Patients With Neurocardiogenic Syncope

NCT01695525 | Completed Early Phase 1

• 1 other identifier: 12945
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Syncope, Vasovagal

Keywords

Neurocardiogenic Syncope; Yoga

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Change in Heart Health

  3 Months, 1 Year

Study Arms (1)

Yoga

EXPERIMENTAL

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

Interventions

Yoga OTHER

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.

Yoga

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of recurrent Neurocardiogenic syncope
• At least one episode of syncope or pre-syncopal event in the last 3 months prior to enrollment

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dhanunjaya Lakkireddy, MD, FACC: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Syncope, Vasovagal

Interventions

Yoga

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Syncope; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Dhanunjaya Lakkireddy, MD, FACC

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: July 5, 2012
• First Posted: September 28, 2012
• Study Start: June 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: June 30, 2015

Record last verified: 2015-06

Locations

US (1)