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CTRI Number  CTRI/2023/03/050656 [Registered on: 14/03/2023] Trial Registered Prospectively
Last Modified On: 11/05/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of Yoga based Cardiac Rehabilitation (Yoga-CaRe) in Heart Failure 
Scientific Title of Study   Effectiveness of Yoga based Cardiac Rehabilitation (Yoga-CaRe) in Heart Failure: A Randomized Controlled Clinical Trial 
Trial Acronym  Yoga-CaRe HF Trial 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Dorairaj Prabhakaran MD DM MSc 
Designation  Executive Director 
Affiliation  Centre for Chronic Disease Control 
Address  Centre for Chronic Disease Control Clinical Trial Department Flat number 52 Second Floor Block C1 Safdurjung Development Area New Delhi

South
DELHI
110016
India 
Phone    
Fax    
Email  dprabhakaran@ccdcindia.org  
 
Details of Contact Person
Scientific Query  
Name  Prof Dorairaj Prabhakaran MD DM MSc 
Designation  Executive Director 
Affiliation  Centre for Chronic Disease Control 
Address  Flat number 52 Second Floor Block C1 Safdurjung Development Area New Delhi


DELHI
110016
India 
Phone    
Fax    
Email  dprabhakaran@ccdcindia.org  
 
Details of Contact Person
Public Query  
Name  Dr Chandrasekaran BNYS MPH 
Designation  Programme Officer 
Affiliation  Centre for Chronic Disease Control 
Address  Flat number 52 Second Floor Block C1 Safdurjung Development Area New Delhi

South
DELHI
110016
India 
Phone  8287992563  
Fax    
Email  chandrasekaran@ccdcindia.org  
 
Source of Monetary or Material Support  
Indian Council for Medical Research New Delhi 
 
Primary Sponsor  
Name  Centre for Chronic Disease Control 
Address  Flat number 52 Second Floor Block C1 Safdurjung Development Area New Delhi 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 14  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Surender Deora  All India Institute of Medical Sciences  Department of Cardiology, Room No 445 OPD building C Block AIIMS JODHPUR
Jodhpur
RAJASTHAN 		 08003996715

drsdeora@gmail.com 
Dr Sadananda  Sri Jayadeva Institute of Cardiovascular Sciences and Research  Department Clinical Research 1st Floor KRS Road Kumabara Koppalu Mysore
Mysore
KARNATAKA 		 0821242150

Sadanand_dm@rediffmail.com 
Dr Ambuj Roy  All India Institute of Medical Sciences  Room #32 7th Floor Department of Cardiology Cardio Thoracic Centre CN Towers All India Institute of Medical Sciences New Delhi
South
DELHI 		 01126594420

drambujroy@gmail.com 
Dr Bhanu Duggal  All India Institute of Medical Sciences  Department of Cardiology Virbhadra Road Shivaji Nagar near Barrage Sturida Colony Rishikesh
Dehradun
UTTARANCHAL 		 09869418148

bhanuduggal2@gmail.com 
Dr Bhupinder Singh  All India Institute of Medical Sciences  Additional Professor and Head Department of cardiology, All India Institute of Medical Sciences Dabwali road Bathinda
Bathinda
PUNJAB 		 8427800682

doc_bhupi@rediffmail.com 
Dr Prasad M R  Dr Prabhakar Kore Hospital  Site Management Office and Department of Cardiology Second Floor Dr Prabhakar Kore Hospital JN Medical College KLE University Nehru Nagar Belgaum
Belgaum
KARNATAKA 		 083124094053

drprasadmr@gmail.com 
Dr Sunil Kumar  JSS Hospital  2nd Floor Department Of Cardiology JSS Hospital MG Road Mysore
Mysore
KARNATAKA 		 08212335555

sunil_cardio@yahoo.co.in 
Dr Jabir Abdullarkutty  Lisie Hospital  Department of Cardiology and Department of Clinical Research PB No 3053 Kochi
Ernakulam
KERALA 		 04842403877

drjabi@yahoo.co.in 
Dr Amit Malviya  North Eastern Indira Gandhi Regional Institute of Medical Sciences   Department of Cardiology North Eastern Indira Gandhi Regional Institute of Medical Sciences Mawdiangdiang, Shillong, Meghalaya
East Khasi Hills
MEGHALAYA 		 08794705698

dramit_malviya@rediffmail.com 
Dr Kiran R Aithal  SDM College of Medical Sciences and Hospital  Department of Medicine SDM College of Medical Sciences and Hospital SDM University Manjushree Nagar Sattur Dharwad
Dharwad
KARNATAKA 		 08362370057

drkiranaithal@yahoo.com 
Dr Subash C Manchanda  Sir Ganga Ram Hospital  Sir Ganga Ram Hospital Cardiology Office 5th Floor Dharam Vira Heart Centre Department of Cardiology Rajinder Nagar New Delhi
North West
DELHI 		 01128744331

doctormanchanda@yahoo.com 
Dr Prabhavathi Batt  Sri Jayadeva Institute of Cardiovascular Sciences and Research  Clinical Research Office 2nd Floor Sri Jayadeva Institute of Cardiovascular Sciences and Research Bannerghatta road 9th Block Jayanagar Bengaluru
Bangalore
KARNATAKA 		 08022977400

prabhavathi_in@yahoo.com 
Dr Nagendra Boopathy  Sri Ramachandra Institute of Higher Education and Research  Department of Cardiology, Sri Ramachandra Institute f Higher Education and Research
Chennai
TAMIL NADU 		 04446928916

srmcclinicalresearch@gmail.com 
Dr Bishav Mohan  Unit- Hero DMC Heart Institute  Additonal Medical Superintendent Unite Hero DMC Heart Insititute Dayanand Medical college and Hospital
Ludhiana
PUNJAB 		 01612304282

bishav_68@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 15  
Name of Committee  Approval Status 
AIIMS Bathinda Institutional Ethics Committee  Approved 
AIIMS Jodhpur IEC  Approved 
AIIMS Rishikesh  Approved 
Centre for Chronic Disease Control  Approved 
Datte Maghe Institute of Higher Education And Research  Approved 
DMC Ludhiana  Approved 
Government General Hospital Guntur  Approved 
Institutional Ethics Committee, AIIMS  Approved 
JSS Medical College IEC  Approved 
KLE Academy of Higher Education and Research  Approved 
NEIGRIHMS  Approved 
SDM College of Medical Sciences and Hospital  Approved 
SJICSR Mysuru IEC  Approved 
Sri Jayadeva Institute Ethics Commitee  Approved 
SRIHER IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I509||Heart failure, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Enhanced Standard Care  The participants in the control group will receive enhanced standard care which includes three educational sessions spread over three months. The educational sessions provides information on healthy life practices and heart failure specific dietary changes physical activity and stress management. The three sessions will be delivered over three months and participants are expected to practice at home regularly till the end of follow-up 
Intervention  Yoga based cardiac rehabilitaton programme for Heart Failure (Yoga-CaRe HF)  The Yoga-CaRe HF programme involves an array of health education component aiming at lifestyle changes dietary changes improving physical activity reducing stress adhering to medications and conventional management long term control of risk factors such as maintenance of healthy weight normal blood pressure and glycemic levels etc. In addition specific yoga practcies such as asana pranayama meditation and relaxative practcies will be taught in 20 sessions over a three months duration. The sessions could be in-person at the hospital and or a virtual session based on feasibility, adaptability and requirements of the participant. The supervised sessions will be supplemented by regular daily practice of yoga at home. Spouses will be encouraged to attend all the sessions and continue home practice. Th training will be delivered over three months and the participants will be expected to practice by themselves till the end of the study follow-up period 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1 Male and female patients above 18years
Physician diagnosed heart failure patients based on ESC guidelines
2 Patients should be NYHA class II and or III
3 Willing and able to attend the complete hospital-based CR programme on their own

Diagnosis of Heart Failure will be based on the European Society of Cardiology ESC Guidelines.
The diagnosis of HF-REF requires three conditions to be satisfied
1 Symptoms typical of Heart Failure
2 Signs typical of Heart Failure
3 Reduced Left Ventricular Ejection Fraction 
 
ExclusionCriteria 
Details  1 Comorbid disease or behavioural or other limitations that interfere with performing Yoga
training or prevent the completion of 1 year of exercise training
2 Elective Cardiovascular procedure or hospitalization planned in the coming 3 months
3 Currently pregnant or intend to become pregnant in the next year
4 Heart failure secondary to significant correctable/reversible cause like primary valvular
disease or correctable congenital heart disease
5 Performance of exercise training/yoga at regular intervals (more than once per week) at a
moderate-to-vigorous intensity at any time in the previous six weeks
6 Participation in other clinical trial 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Centralized 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Co-primary outcome -1
Major adverse cardiovascular events which is a composite
of all-cause mortality, nonfatal stroke and all cause hospitalisations at a median follow-up of one
year

Co-primary outcome-2
Quality of life as assessed by the Minnesota Living with Heart Failure Questionnaire MLHFQ at three months 		 Co-primary outcome-1
Median follow-up of one
year and Co-primary outcome-1
Three months 
 
Secondary Outcome  
Outcome  TimePoints 
Six-minute walk test 6MWT   3 and 6 months 
Cardiovascular mortality at end of trial follow-up  Median Follow-up 1 year 
Heart Failure Specific Hospitalisation at end of trial follow-up  Median Follow-up 1 year 
Quality of life as measured by MLHFQ  6 months and 12 months 
Self rated health as measured by European Quality of Life Questionnare EQ-5D-5L   3 and 6 months 
Smoking Cessation   3 months and 1 year 
Adherence to prescribed therapy   Three months and final follow-up (median 1 year) 
Self reported frailty as reported by Fried Frailty Phenotype tool   3 and 6 months 
Cost effectiveness   Median Follow-up 1 year 
Quality of life and depression among care-givers   3 months and 6 months 
Safety outcomes   Median Follow-up 1 year 
 
Target Sample Size   Total Sample Size="3500"
Sample Size from India="3500" 
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 3 
Date of First Enrollment (India)   03/04/2023 
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="1"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Not Applicable 
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 -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  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 - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [dprabhakaran@ccdcindia.org].

  6. For how long will this data be available start date provided 10-08-2027 and end date provided 01-08-2037?
    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  
Cardiac rehabilitation programme, a Class-I indication for patients  with heart failure is virtually non-existent in India. India is home to millions of people with heart failure. A structured, culturally appropriate cardiac rehabilitation model suitable for India is lacking. Yoga has been widely used in clinical settings for its potential cardiovascular benefits among others. However, conclusive evidence on the effect of Yoga based cardiac rehabilitation programme in patients with heart failure is not established through adequately powered randomized controlled trials on several important outcomes such as clinical endpoints such as all-cause mortality and all-cause hospitalisation, patient-reported outcomes such as disease-specific quality of life outcomes, disease specific functional outcome measures such as six-minutes’ walk test and the mchanistic pathways through which Yoga-CaRe could exert benefits are not adequately explored.

The specific objectives of the research study are
1. To develop a Yoga-based Cardiac Rehabilitation programme (Yoga-CaRe) for patients with Heart Failure following a systematic process.
2. To test the effectiveness Yoga-CaRe programme on cardiovascular events and quality of life in a multi-centre randomized controlled trial
3. To evaluate the mechanism behind the potential benefits of yoga in a mechanistic sub-study.
 
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