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CTRI Number  CTRI/2017/12/010917 [Registered on: 19/12/2017] Trial Registered Prospectively
Last Modified On: 04/06/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Yoga in patients with Vasovagal Syncope 
Scientific Title of Study
Modification(s)  		 Effect of Yoga on Clinical Outcomes and Quality of Life in patients with Vasovagal Syncope. A randomized controlled trial 
Trial Acronym  LIVE-Yoga 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Gautam Sharma 
Designation  Professor Incharge 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room No. 7004, 7th Floor, Convergence Block, Center for Integrative Medicine and Research(CIMR)

South West
DELHI
110029
India 
Phone  01126549326  
Fax    
Email  drgautamsharma12@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Gautam Sharma 
Designation  Professor Incharge 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room No. 7004, 7th Floor, Convergence Block, Center for Integrative Medicine and Research(CIMR)

South West
DELHI
110029
India 
Phone  01126549326  
Fax    
Email  drgautamsharma12@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Gautam Sharma 
Designation  Professor Incharge 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room No. 7004, 7th Floor, Convergence Block, Center for Integrative Medicine and Research(CIMR)

South West
DELHI
110029
India 
Phone  01126549326  
Fax    
Email  drgautamsharma12@gmail.com  
 
Source of Monetary or Material Support  
FUNDING AGENCY: MINISTRY OF AYUSH INFRASTRUCTURAL SUPPORT : ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI 
 
Primary Sponsor  
Name  Ministry of AYUSH 
Address  Ayush Bhawan, B Block GPO Complex, INA, New Delhi 110 023  
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Gautam Sharma  All India Institute of Medical Sciences  Room No. 7004, 7th Floor, Convergence Block, Center for Integrative Medicine and Research(CIMR)
South West
DELHI 		 01126549326

drgautamsharma12@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Institute Ethics Committee  Approved 
Institute Ethics Committee  Approved 
Institute Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R55||Syncope and collapse,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Standard Medical Therapy  The patient will only receive standard medical therapy (There is no specific therapy or drug that cures VVS but the usually prescribed standard medical treatment includes lifestyle modifications to avoid injury (Hydration etc.), the counter-pressure maneuver and/or prescription of β-blocker(AHA-class IIb). A log book will be given to the patients to report, frequency and duration of pre-syncope and syncope episodes.  
Intervention  Yoga  Patients will be given Yoga as an intervention along with the standard medical therapy. The yoga intervention comprises of physical postures, pranayama (controlled breathing), and meditation. A log book will be given to the patients to report, frequency and duration of pre-syncope and syncope episodes along with adherence to yoga.  
 
Inclusion Criteria
Modification(s)  
Age From  15.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. All adults between 15-70 years of age
2. Both genders
3. Diagnosed to have VVS
(HUTT positive within last 3 months)
4. At least two episode of syncope or pre-syncope event in the last 3 months prior to enrolment
5. Patients with no other cause of Syncope
6. Patients willing and able to practice Yoga at least for 40 minutes /5 days/week 
 
ExclusionCriteria 
Details  1. Not willing or not fulfilling the criteria of inclusion
2. Practicing yoga before
3. Accelerated hypertension(> 180/110 mm Hg)
4. Any disease which is potent to cause syncope like significant arrhythmias (Atrial Fibrillation, Atrial Flutter, Ectopic Atrial Tachycardia), Mobitz Type 2, Complete Heart Block, Sinus Bradycardia(Pause > 3 sec), Sick Sinus Syndrome with AF(pause > 5 sec in awake state), Heart Failure(LVEF ≤ 35 %, > NYHA-II) 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
To evaluate the effect of Yoga on the clinical outcome (Number of episodes of syncope and presyncope ) of patients with VVS over a follow-up period of one year.  Baseline, 6 weeks, 6 months, 12 months
 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
To evaluate the effect of Yoga on the Quality of Life(QoL) in patients with Vasovagal Syncope.
 		 Baseline, 6 weeks, 6 months, 12 months 
To evaluate the short-term effect of yoga in HUTT positive response in patients with Vasovagal Syncope.  Baseline, 6 weeks 
To evaluate the effect of Yoga on Autonomic function in patients with Vasovagal Syncope.  Baseline, 6 weeks 
Adherence of yoga practice of the patients with Vasovagal Syncope.  Baseline, 6 weeks, 6 months, 12 months 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "55"
Final Enrollment numbers achieved (India)="55" 
Phase of Trial   Phase 1/ Phase 2 
Date of First Enrollment (India)   01/01/2018 
Date of Study Completion (India) 30/12/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Published in 2022 JACC Clinical Electrophysiology. doi_10.1016/jacep.2021.09.007  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - None of the above

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drgautamsharma12@gmail.com].

  6. For how long will this data be available start date provided 01-06-2022 and end date provided 01-06-2025?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  

The proposed study is a two-parallel-arm pre-preliminary phase 2 randomized controlled trial to evaluate the clinical outcomes (No. of episodes of syncope and presyncope) of patients with Vasovagal Syncope (VVS). 

Based on the inclusion and exclusion criteria, the patients will be randomized to either Intervention arm or control arm.

1. Intervention arm: Yoga as an intervention will be given to the patient along with the standard medical therapy for the duration of one year.

The Yoga Intervention includes two phases:

Phase 1: Baseline to 6 months:-

There will be 14 supervised sessions for the duration of 40 minutes each (first 8 supervised sessions at Center for Integrative Medicine and Research (CIMR), AIIMS; Remaining 6 supervised sessions over a period of 6 months at CIMR or via video conferencing). 

The supervised yoga intervention will be given under the guidance of an institutionally certified yoga therapist, who will also assist the participants in home-based Yoga sessions by providing video and telephonic consultations. Participants will be given booklets and will be encouraged to practice at home.

 Phase 2: 6 months to 12 months:-

The participants will be advised to practice yoga at home for the duration of 40 minutes/day for at least 5 days/ week.

2. Control arm: The patients in control arm will receive only standard medical therapy offered at All India Institute of Medical Sciences (AIIMS), New Delhi for the same period of time.

Follow-up visits & assessment: Baseline, 6 weeks, 6 months and 12 months. 

After baseline assessment, first evaluation will be done at 6 weeks [(HUTT and Holter recordings) along with the clinical events, WHO QoL BREF questionnaire & Syncope Functional Status Questionnaire (SFSQ)] and then repeat assessments with only clinical events and questionnaires at  6 months and 12 months  for each patient.

NOTE: A logbook will be given to the patients to report frequency of pre-syncope and syncope episodes and adherence to yoga therapy. The compliance to yoga will be assessed telephonically and through logbook verification during scheduled visits.

 
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