| CTRI Number |
CTRI/2012/02/002408 [Registered on: 08/02/2012] Trial Registered Prospectively |
| Last Modified On: |
22/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Other (Specify) [YOGA based Cardiac Rehabilitation Programme] |
| Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
Modification(s)
|
A study on effectiveness of YOGA based cardiac rehabilitation programme in India and United Kingdom |
|
Scientific Title of Study
|
Effects of a yoga-based cardiac rehabilitation programme (Yoga-CaRe)
on cardiovascular health: a clinical trial (India) and mechanistic study (UK) |
|
Secondary IDs if Any
|
| Secondary ID |
Registry |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dorairaj Prabhakaran |
| Address |
C-1/52, IInd Floor, Safdarjung Development Area, New Delhi
South
DELHI
110016
India |
| Phone |
011-26850117 |
| Fax |
011-26850588 |
| Email |
dprabhakaran@ccdcindia.org |
|
Details Contact Person
Scientific Query
|
| Name |
Dorairaj Prabhakaran |
| Address |
C-1/52, IInd Floor, Safdarjung Development Area, New Delhi
DELHI
110016
India |
| Phone |
011-26850117 |
| Fax |
011-26850588 |
| Email |
dprabhakaran@ccdcindia.org |
|
Details Contact Person
Public Query
|
| Name |
Dorairaj Prabhakaran |
| Address |
C-1/52, IInd Floor, Safdarjung Development Area, New Delhi
DELHI
110016
India |
| Phone |
011-26850117 |
| Fax |
011-26850588 |
| Email |
dprabhakaran@ccdcindia.org |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
P.O. Box No. 4911
Ansari Nagar
New Delhi - 110029
India |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Medical Research Council |
14th Floor
One Kemble Street
London
WC2B 4AN
|
|
|
Countries of Recruitment
|
India
United Kingdom |
Sites of Study
Modification(s)
|
| No of Sites = 18 |
| Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrRaghavaSharma |
Lalitha Super Specialties Hospitals (P) LTD |
Department of Cardiology
Kothapet Guntur – 522001
Andhra Pradesh India
Guntur
|
919440808620
918632332866
drpvr.lssh@gmail.com |
| Dr Ambuj Roy |
All India Institute of Medical Sciences |
Department of Cardiology
Ansari Nagar
New Delhi
New Delhi
|
09868393945
drambujroy@gmail.com |
| Dr K U Natarajan |
Amrita Institute of Medical Sciences |
Department of Cardiology
Ponekkara PO
Cochin 682041
Kerala India
Ernakulam
|
91-484-2853570
kumar_rk@yahoo.com |
| Dr Joel Nesaraj |
Bethesda Hospital |
Department of Cardiology
P.B. No. 56
Mission Compound Ambur 635802 Vellore Tamil Nadu
Vellore
|
09443235031
joel.nesraj@rediffmail.com |
| Dr Bhaskar Rao |
CARE Hospital Heart institute |
Department of Cardiology
10-50-11/5
Waltair Main Roadram Nagar
Visakhapatnam
Andhra pradesh
INDIA 530003
Visakhapatnam
|
081-2734766
bhaskarstudies@hotmail.com |
| DrBhishav Mohan |
Dayanand medical college and hospital |
Department of Cardiology
Tagore Nagar
Civil lines Ludhiana 141001
Punjab India
Ludhiana
|
09876741158
bishav_68@yahoo.co.in |
| Dr Bhim Shankar |
Frontier Life Line (K.M.Cherian Heart Foundation) |
Department of Cardiology
R-30-C Ambattur Industrial Estate
Mogappair Chennai-600037
Thiruvallur
|
09841825507
bhimshankarraj@yahoo.co.in |
| Dr Natarajan |
G. Kuppuswamy Naidu Memorial Hospital |
Department of Cardiology
P.B. No. 6327
Nethaji Road
Pappanaickenpalayam
Coimbatore - 641 037
Coimbatore
|
09842206679
dr_snrcbe@yahoo.co.in |
| Dr Vivek Chaturvedi |
G.B Pant Hospital |
Department of Cardiology
J. L. Nehru Marg
New Delhi 110002
New Delhi
|
09718599111
chaturvedimd@gmail.com |
| Dr P C Negi |
Indira Gandhi Medical College |
Department of Cardiology
Shimla 171001
Himachal Pradesh
India
Shimla
|
91-9418103709
prakashnegi@hotmail.com |
| Dr Sanjay Porwal |
J.N. Medical College, KLE University |
Department of Cardiology
Belgaum-590010
Karnataka India
Belgaum
|
91-831-24094053
drsanjayporwal@gmail.com |
| Dr Amritha Ganesh |
Mahatma Gandhi Medical College & Research Institute |
Department of Cardiology
PulliarKuppam
Puducherry
Chennai
|
04132615458
amirtha2001@rediffmail.com |
| Dr RameshBabu |
Medwin Hospital |
Department of Cardiology
Nampally
Hyderabad 500001 India
Hyderabad
|
09177000889
4023204053
rameshbabubyrapaneni@yahoo.co.in |
| Dr Chidambaram |
Rajamuthiah medical College & Hospital |
Department of Cardiology
Annamali Nagar 608 002
Cuddalore
|
09829798107
deanrmmc@yahoo.com |
| Dr Abraham Oomman |
Ramana Maharshi Rangammal Hospital |
Department of Cardiology
Athiyandal-606603
Tiruvanamalai
|
09841174578
914175236693
drabrahamoomman@gmail.com |
| Dr Satyendra Tiwari |
Sanjay Gandhi PGIMS |
Department of Cardiology
Lucknow 226014
Lucknow
|
0522-2668700
stewari_sgpgi@yahoo.com |
| Dr Subhash Chander Manchanda |
Sir Ganga Ram Hospital |
Department of Cardiology
New Rajinder Nagar
New Delhi 110060
New Delhi
|
011-28744331
doctormanchanda@yahoo.com |
| Dr Ravi Math |
Sri Jayadeva hospital |
Department of Cardiology
Bangalore
Bangalore
|
09535108410
ravismath@rediffmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 21 |
| Name of Committee |
Approval Status |
| All India Institute of Medical Sciences |
Approved |
| Amrita Institute of Medical Sciences |
Approved |
| Apollo Hospitals |
Approved |
| CARE Hospital |
Approved |
| CARE Hospital Heart institute |
Approved |
| Centre for Chronic Disease Control |
Approved |
| Dayanand medical college and hospital |
Approved |
| Fortis Escorts Hospital |
Approved |
| Frontier Life Line |
Approved |
| G. Kuppuswamy Naidu Memorial Hospital |
Approved |
| Indira Gandhi Medical College |
Approved |
| JSS Medical College and Hospital |
Approved |
| King Georges Medical University |
Approved |
| KLE University |
Approved |
| Lalitha Super Specialties Hospitals (P) LTD |
Approved |
| Lisie Hospital |
Approved |
| M S Ramaih Medical College and Hospitals |
Approved |
| SAL Hospital |
Approved |
| Shri B.M.Patil Medical College, Hospital and Research Centre |
Approved |
| Sir Ganga Ram Hospital |
Approved |
| Sri Jayadeva hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Acute Myocardial Infarction |
| Patients |
Acute myocardial infarction, unspecified |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard Care |
The control arm will receive enhanced standard care involving a leaflet in the hospital before discharge (session 1), followed by two sessions offering standard educational advice at weeks 5 and 12 (sessions 2, 3). The sessions will be delivered in groups (similar to the intervention). A different member of the team (i.e. not yoga instructor) will deliver these sessions to avoid contamination. |
| Intervention |
YOGA based cardiac rehabilitation programme |
The intervention being assessed is Yoga-CaRe, a yoga-based cardiac rehabilitation programme, delivered at the hospital in 13 sessions spread over 3 months, complemented
by audio-video material for self-supervised sessions at home. All Yoga- CaRe sessions will be provided by the Yoga-CaRe instructor. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Male and female patients 30 - 80 years old
• Patients with first or consequent acute myocardial infarction who survive to hospital
discharge. Myocardial infarction will be confirmed by standard definition (symptoms,
cardiac enzymes and electrocardiographic changes).28 Those that have undergone a
revascularisation procedure during previous or current admission will also be eligible.
• Willing and able to attend the complete hospital-based CR programme on their own
• Patients who are willing to consent. |
|
| ExclusionCriteria |
| Details |
• Patients who are not willing to consent. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) The primary outcome measure will be a composite of total mortality, nonfatal myocardial infarction and stroke.
2) The co-primary outcome of quality of life outcome will be assessed by the EuroQol EQ-5D Health-Related Quality of Life (HRQOL)questionnaire |
1) At one year.
2) At 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Return to pre-infarct daily activities will be assessed by questionnaire
2) Data on smoking cessation and compliance with medication for secondary prevention will
be based on self-reports
3) Cost-effectiveness will be assessed by the EuroQoL method |
1) At 12 week
2) At 12-week
3) At 12 week & 6-monthly |
|
|
Target Sample Size
|
Total Sample Size="4080"
Sample Size from India="4000" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/10/2012 |
| Date of First Enrollment (Global) |
01/10/2012 |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
Modification(s)
|
Chandrasekaran AM, Kinra S, Ajay VS, Chattopadhyay K, Singh K, Singh K, Praveen PA5, Soni D, Devarajan R, Kondal D, Manchanda SC, Hughes AD, Chaturvedi N, Roberts I, Pocock S, Ebrahim S, Reddy KS, Tandon N, Prabhakaran D; Yoga-CaRe Trial Team. Effectiveness and cost-effectiveness of a Yoga-based Cardiac Rehabilitation (Yoga-CaRe) program following acute myocardial infarction: Study rationale and design of a multi-center randomized controlled trial. Int J Cardiol. 2019 Apr 1;280:14-18. |
Brief Summary
Modification(s)
|
Cardiovascular diseases cause considerable death and disability in India and the UK, and secondary prevention is a priority area for both governments. Cardiac Rehabilitation Programmes (CR Programs) aim to restore optimal functioning and reduce the risk of adverse vascular outcomes in cardiac patients. CR programmes are often considered unaffordable in developing countries, including India; as a result CR programmes are virtually non-existent. Yoga practices are effective in improved physical fitness, stress reduction and lifestyle change, at the same time entails considerably fewer resources; as a result a yoga-based CR programme may be more feasible to implement at scale in India, in addition to being culturally appropriate. In the UK, yoga may appeal to certain disadvantaged groups (e.g. ethnic minorities, women and the elderly) that currently have low CR uptake. In this background, the ICMR and Medical Research Council of UK has selected this research proposal for funding. The study has two Components: The India Study: In the India component of the study, we plan to summarise existing knowledge on cardiovascular health effects of yoga from scientific literature and yogic texts, and apply that knowledge to a recommended model of CR to develop a yoga-based CR programme (Yoga-CaRe). Then, we will evaluate the effectiveness and cost-effectiveness of Yoga-CaRe in a large clinical trial in India, randomising 4,000 patients with acute myocardial infarction to receive Yoga-CARE or enhanced standard care, and follow them for quality of life and cardiac morbidity and mortality over one year. The UK Study: In the UK component of the study we plan to perform a mechanistic study which will provide complementary information to the clinical trial in India; 80 patients with AMI will be randomised to receive yoga classes in addition to CR (routinely offered in the UK), and assessed for the acute (after first yoga class) and chronic (after 3 months) effects of yoga on neuro-endocrine pathways, cardiovascular risk factors and sub-clinical outcomes. Providing a sound scientific mechanism for observed clinical effects is vital for traditional therapies to gain wider acceptance. The expected outcomes of this research include a scalable intervention and greater collaboration between India and UK researchers by working on this cross-disciplinary translational research project, that plays to the complementary strengths of the two research groups (large clinical networks in India and sophisticated laboratory facilities in the UK project) and health belief systems (modern Western and traditional Indian). |
