| CTRI Number |
CTRI/2017/09/009925 [Registered on: 26/09/2017] Trial Registered Retrospectively |
| Last Modified On: |
30/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role of yoga in patients with heart attack |
|
Scientific Title of Study
|
Evaluation of Autonomic tone, Vascular and Endothelial function in Myocardial Infarction Patients undergoing Yoga based Cardiac Rehabilitation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S Edmin Christa |
| Designation |
Research Scholar |
| Affiliation |
AIIIMS, New Delhi |
| Address |
Department of Physiology
AIIMS
New Delhi
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
drchristabnys@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K K Deepak |
| Designation |
Professor and Head |
| Affiliation |
AIIIMS, New Delhi |
| Address |
Department of Physiology
AIIMS
New Delhi
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
kkdeepak@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Edmin Christa |
| Designation |
Research Scholar |
| Affiliation |
AIIIMS, New Delhi |
| Address |
Department of Physiology
AIIMS
New Delhi
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
drchristabnys@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences
Ansari Nagar
New Delhi |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
All India Institute of Medical Sciences
Ansari nagar
New Delhi |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| S Edmin Christa |
AIIMS |
Room no:6005, Autonomic and Vascular function lab, Department of Physiology, Convergence Building, AIIMS
New Delhi
South
DELHI |
8373961624
drchristabnys@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for Postgraduate Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I219||Acute myocardial infarction, unspecified, Myocardial Infarction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard Care Group |
Widely accepted standard medical care for MI |
| Intervention |
yoga care group |
standard care and yoga intervention |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with MI
2. Willingness to attend the yoga sessions
|
|
| ExclusionCriteria |
| Details |
1. Patients who regularly practice yoga
2. Current participation in other clinical trials
3. Severe valvular diseases, arrhythmias, heart failure (Killip class IV), end stage renal diseases and end stage liver diseases.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Heart rate variability (HRV),
Blood Pressure Variability (BPV),
Baroreflex Sensitivity (BRS), Pulse wave velocity (PWV),
Augmentation Index (AIx), Flow mediated dilatation (FMD)
|
Baseline - 3 weeks post MI
Intervention - 3 Months
Post intervention - at the end of 3rd month
follow up - 3 months after intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Echocardiography |
Baseline - 3 weeks post MI
Intervention - 3 Months
Post intervention - at the end of 3rd month
follow up - 3 months after intervention |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/05/2015 |
| Date of Study Completion (India) |
22/06/2017 |
| 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)
|
Effect of Yoga-Based Cardiac Rehabilitation on Heart Rate Variability: Randomized Controlled Trial in Patients Post-MI.
Christa E, Srivastava P, Chandran DS, Jaryal AK, Yadav RK, Roy A, Deepak KK.
Int J Yoga Therap. 2019 Nov;29(1):43-50. doi: 10.17761/2019-00019. Epub 2019 Jan 31.
PMID:30702948 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The therapeutic landscapes of yoga are diverse. Several studies have shown that yoga and meditation control risk factors for cardiovascular disease like hypertension, type II diabetes and insulin resistance, obesity, lipid profile, psychosocial stress and smoking. Some randomized studies suggest that yoga / meditation could retard or even regress early and advanced coronary atherosclerosis.
CR is the process of restoring desirable levels of physical, social, and psychological functioning after the onset of cardiovascular illness. The aims of CR programmes are to optimise patient’s functioning, enhance quality of life, and minimise the risk of recurrent cardiac events. Comprehensive CR programmes are multi-component interventions, which include elements of exercise training, relaxation and stress management, secondary prevention, and pay attention to the patient’s psychosocial adjustment. Yoga covers most of the elements of a comprehensive CR programme: improved physical fitness, stress reduction and lifestyle.
The proposed research is to understand the mechanism behind the effects of Yoga based cardiac rehabilitation on autonomic, vascular and endothelial functions in patients following Acute Myocardial Infarction. Most of the studies on yoga are limited to healthy subjects and diseased conditions other than myocardial infarction. This study is unique in that there is deficiency of data on the effect of yoga based cardiac rehabilitation in acute Myocardial infarction patients. Therefore, this study proposes to test the mechanisms underlying the effects of Yoga-Cardiac Rehabilitation program in patients with acute myocardial infarction to suggest a road map for future enhancement of Yoga based Cardiac rehabilitation. |