| CTRI Number |
CTRI/2024/06/068372 [Registered on: 05/06/2024] Trial Registered Prospectively |
| Last Modified On: |
06/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Yoga] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Yoga-Based Cardiac Rehabilitation Program in Myocardial Infarction |
|
Scientific Title of Study
|
Integrated Yoga-Based Cardiac Rehabilitation Program in Myocardial Infarction |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shreyansh Chauhan |
| Designation |
Ph.D. (Research Scholar) |
| Affiliation |
Banaras Hindu University |
| Address |
Department of cardiology, Faculty of Modern Medicine, Institute of Medical Sciences, Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8126679136 |
| Fax |
|
| Email |
shreyanshchauhan099@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dharmendra Jain |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Department of cardiology, Faculty of Modern Medicine, Institute of Medical Sciences, Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9319048929 |
| Fax |
|
| Email |
djaincard@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dharmendra Jain |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Department of cardiology, Faculty of Modern Medicine, Institute of Medical Sciences, Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9319048929 |
| Fax |
|
| Email |
djaincard@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Medical Sciences, Banaras Hindu University, Varanasi 221005 India |
|
|
Primary Sponsor
|
| Name |
Shreyansh Chauhan |
| Address |
Department of Cardiology, Faculty of Modern Medicine, Institute of Medical Sciences, Banaras Hindu University, Varanasi Pin code 221005, India |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Dr Dharmendra Jain |
Sir Sunder Lal Hospital |
Third Floor, CCU, Department of Cardiology, Faculty of Modern Medicine, Sir Sunder Lal Hospital Institute of Medical Sciences, Banaras Hindu University
Varanasi
UTTAR PRADESH |
8126679136
shreyanshchauhan099@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Institute of Medical Sciences Banaras Hindu University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I509||Heart failure, unspecified, (2) ICD-10 Condition: I213||ST elevation (STEMI) myocardial infarction of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard Exercise Based Cardiac Rehabilitation |
Participants in this group will receive standard medical treatment coupled with exercise-based rehabilitation care.
Phase 1: Inpatient programme
Phase 2: Discharge patients. |
| Intervention |
Yoga- Based Cardiac Rehabilitation |
Participants in this group will receive standard medical treatment along with the additional care of Yoga as part of their rehabilitation program in three different phases.
Phase 1 : (Intervention - First Week)
Phase 2 : (Intervention - 2nd – 4th Week)
Phase-3 : (Intervention of 7th Week beyond) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1 Male and female patients aged above 18 years.
2 Patient with first-time Myocardial Infarction.
3 Consent and compliance with all aspects of the study, protocol, and methods, providing data during follow-up contact.
|
|
| ExclusionCriteria |
| Details |
1 Patients who have undergone Coronary artery bypass graft will not be included.
2 The patient encountered recurrent Myocardial Infarction in his life will not be considered.
3 Reporting history of concurrent pulmonary diseases like chronic obstructive pulmonary disease and severe musculoskeletal diseases like osteoarthritis restraining the patient from performing yoga.
4 Patients with valvular heart disease for whom practicing yoga will not be easy.
5 Cognitive or severe psychopathology that could prevent participation.
Involvement with any other ongoing studies.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Effects of Yoga-Care Rehabilitation program on Cardiac Profile -LVEF, BNP, and 6-MWT in MI patients |
Three Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the potential of yoga in improving serum inflammation markers and enhancing overall quality of life.
2. Effectiveness of physiotherapeutic intervention in MI and comparative analysis with yoga therapy.
|
Three Months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
16/06/2024 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study, conducted at Sir Sunderlal Hospital, Banaras Hindu University, Varanasi, aims to assess the efficacy of an Integrated Yoga-Based Cardiac Rehabilitation Program for patients recovering from Myocardial Infarction (MI). Patients will be randomly assigned to two groups: a study group receiving Integrated Yogic approach with standard pharmacotherapy, and a control group receiving exercise-based standard medical care. The study will evaluate the program’s effects on cardiac profile parameters such as LVEF, BNP, and 6-MWT, as well as its impact on inflammatory markers IL-6 and hsCRP, and overall quality of life. The duration of the main protocol, from screening to last follow-up, is estimated to be 12 months. Initial study will involve 10 randomized patients in each arm, with the main study to be conducted with total 60 patients in both the groups. Inclusion criteria include patients above 18 years of age experiencing first-time MI, while exclusion criteria involve severe musculoskeletal diseases and other associated physiological conditions. Statistical analysis will include assessment of cardiac performance using LVEF, BNP, and 6-minute walking test, as well as evaluation of mental, social, and emotional health using inflammatory markers IL-6 and WHO-QoL |