FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2018/08/015397 [Registered on: 20/08/2018] Trial Registered Prospectively
Last Modified On: 24/08/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Yoga for patients with Implantable Cardiac Devices 
Scientific Title of Study   A Randomized controlled trial to evaluate the efficacy of Yoga on Psychological and Arrhythmic outcomes of patients implanted with Implantable Cardioverter Defibrillator 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nitish Naik 
Designation  PROFESSOR  
Affiliation  All india institute of medical sciences 
Address  Room No-25, 7th Floor, CN centre All India Institute of Medical Sciences

New Delhi
DELHI
110029
India 
Phone  01126593218  
Fax    
Email  nitishnaik@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Nitish Naik 
Designation  PROFESSOR  
Affiliation  All india institute of medical sciences 
Address  Room No-25, 7th Floor, CN centre All India Institute of Medical Sciences

New Delhi
DELHI
110029
India 
Phone  01126593218  
Fax    
Email  nitishnaik@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Nitish Naik 
Designation  PROFESSOR  
Affiliation  All india institute of medical sciences 
Address  Room No-25, 7th Floor, CN centre All India Institute of Medical Sciences

New Delhi
DELHI
110029
India 
Phone  01126593218  
Fax    
Email  nitishnaik@yahoo.co.in  
 
Source of Monetary or Material Support  
AYUSH BHAWAN, B Block, GPO Complex, INA Colony, New Delhi, Delhi 110023 
 
Primary Sponsor  
Name  MINISTRY OF AYUSH 
Address  AYUSH BHAWAN, B Block, GPO Complex, INA Colony, New Delhi, Delhi 110023 
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 Nitish Naik  ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI  Centre for Integrative Medicine and Research, AIIMS Convergence block, 7th Floor, Ansari Nagar, New Delhi
New Delhi
DELHI 		 01126593218

nitishnaik@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, AIIMS   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients implanted with Implantable Cardioverter Defibrillator (ICD),  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Comparator Agent  nil  Not Applicable 
Intervention  YOGA   Yoga intervention will be performed at the Centre for Integrative Medicine and Research (CIMR) at AIIMS, New Delhi. Along with the standard medical therapy, patients assigned to the yoga group shall undergo the yoga intervention, which comprises of physical postures, pranayama (controlled breathing), and meditation. There will be 5 supervised sessions in first week followed by 3 supervised sessions per month in the first three months till the first follow-up period. Each session will have a pre-planned curriculum that will progressively made more challenging which will facilitate adherence and secure repeatability of the intervention. Subsequently patients will perform home based Yoga (every day or with a frequency of at least 5 sessions per week).  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients between 18to 60 years of age
2. ICD implanted at least 8 weeks prior
3. Willing to participate in Yoga
4. NYHA Class I or II symptoms
5. Deemed ready to participate by their physician.
 
 
ExclusionCriteria 
Details  1. Contraindications to Yoga
2. Advanced heart failure (NYHA Class III/IV)
3. Pregnancy
4. Patients already practicing regular Yoga or receiving any other alternative medicine for the same desired effect
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. ICDs/ CRT-Ds burden of ventricular arrhythmia will be assessed from device interrogation.
2. Florida Shock Anxiety Scale (FSAS) will be used to access the shock anxiety
3. Zung self-assessment anxiety score (SAS)
4. Zung self-assessment depression score (SDS)
5. Quality of Life outcomes will be measured using the WHO QoL BREF questionnaire.
 		 Data collection will be done at baseline, 12 weeks & 6 months in person at the hospital. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Florida Patient Acceptance Survey (FPAS) will be used to access the acceptance of the ICD device by the patient
2. Mental stress will be assessed using the Perceived Stress Scale (PSS)
3. A log book will be used to evaluate the frequency of hospital visit and need of drug regimen modification
 		 6 months 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   01/09/2018 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not yet Published  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Ventricular arrhythmias are an important cause of morbidity, mortality and sudden death. There is a direct co-relationship between burden of ventricular arrhythmias and total mortality. Autonomic tone plays a central role in occurrence of ventricular arrhythmias with Yoga having a profound influence on cardiovascular physiology through its effects on central neural outflow and autonomic tone. It also improves mental and psychological wellbeing through central effects on mood and emotion.  This is a prospective, randomized, controlled study designed to test the effects of yoga on psychological and arrhythmic outcomes in patients with structural heart disease. Patients with structural heart disease who have an implantable cardioverter defibrillator or a cardiac resynchronization device with defibrillator will be randomized to either Yoga Intervention (with usual care) or usual care. Patients will have periodic assessment of clinical characteristics, arrhythmia burden, psychological and quality of life parameters at baseline, 12 weeks and at end of study. 

 
Close