| CTRI Number |
CTRI/2025/07/091003 [Registered on: 16/07/2025] Trial Registered Prospectively |
| Last Modified On: |
15/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
In our study we will be including patients with heart bypass (CABG). We will be giving yoga exercises to see their improvement in quality of life and fitness. |
|
Scientific Title of Study
|
Effect of yoga-integrated Cardiac Rehabilitation Implemented via Home and Hospital-Based Approaches on Inflammatory Markers, Exercise Capacity, and Quality of Life in Post-Coronary Artery Bypass Graft (CABG) Patients: A Randomized Controlled Trial. |
| Trial Acronym |
CABG- Coronary Artery Bypass Graft |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MGM school of physiotherapy |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrDanish siddiqui |
| Designation |
Post graduate student |
| Affiliation |
MGM school of physiotherapy |
| Address |
Abrar colony beed by pass road near Patel lawns aurangabad
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
7776036177 |
| Fax |
|
| Email |
danishsiddiqui53@Yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr junneshwar bidve |
| Designation |
Professor and HOD |
| Affiliation |
MGM school of physiotherapy |
| Address |
Department of Cardiovascular and respiratory physiotherapy OPD 4, MGM school of Physiotherapy, Chh. Sambhajinagar, Maharashtra 431003, India
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
8237197885 |
| Fax |
|
| Email |
junneshwarb@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr junneshwar bidve |
| Designation |
Professor and HOD |
| Affiliation |
MGM school of physiotherapy |
| Address |
Department of Cardiovascular and respiratory physiotherapy OPD 4, MGM school of Physiotherapy, Chh. Sambhajinagar, Maharashtra 431003, India
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
8237197885 |
| Fax |
|
| Email |
junneshwarb@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM school of Physiotherapy, N-6 CIDCO, Aurangabad 431003, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
MGM school of physiotherapy |
| Address |
N-6 cidco aurangabad 431003 Maharashtra, India |
| 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 |
| DANISH SIDDIQUI |
mgm school of physiotherapy |
Department of Cardiovascular and respiratory physiotherapy OPD 4, MGM school of Physiotherapy, Chh. Sambhajinagar, Maharashtra 431003, India
Aurangabad
MAHARASHTRA |
7776036177
ds833558@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee for research on human subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z951||Presence of aortocoronary bypass graft, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Cardiac Rehabilitation Only
|
Warm-up:
Stretching and breathing exercises.
Main session:
Treadmill walking (10 minutes).
Cycling (10 minutes).
Cool-down (5-10 minutes): Stretching and relaxation techniques.
|
| Intervention |
Cardiac rehabilitation with yoga |
Group A: (Experimental) Yoga + Cardiac Rehabilitation
Warm-up: Stretching and breathing exercises.
Main session:
Yoga:
Tree pose, Mountain pose, Chair pose, and Triangular pose.
Cardiac rehabilitation:
Treadmill walking (10 minutes) + Cycling (10 minutes).
Cool-down (5-10 minutes):
Pranayama and Bhramari breathing techniques.
|
| Comparator Agent |
Home-Based Yoga + Cardiac Rehabilitation |
Initial Guidance: Participants receive a detailed plan and a demonstration session.
Daily Home Routine:
Warm-up: Stretching and breathing exercises (5-10 minutes).
Main session:
Yoga:
Tree pose, Mountain pose, Chair pose, and Triangular pose.
Walking: 10-15 minutes in their environment.
Cool-down:
Pranayama and Bhramari breathing techniques.
Monitoring: Participants maintain a diary or log and report weekly.
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients who have undergone CABG surgery within the last 8 weeks
Age group 40-70 years
Willingness to participate in the study and provide informed consent
Ability to perform physical exercises with minimal assistance
|
|
| ExclusionCriteria |
| Details |
Patients with significant postoperative complications, e.g., infection, unstable angina
History of severe musculoskeletal disorders that impair mobility
Unwillingness to adhere to the rehabilitation protocol or follow-up assessments |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
6 min walk test
MacNew HRQOL questionnaire |
pre- and post-intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
ESR Erythrocyte Sedimentation Rate
CRP C-reactive protein |
pre- and post-intervention |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
30/07/2025 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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 randomized controlled trial investigates the impact of yoga-integrated cardiac rehabilitation (CR) delivered through home-based and hospital-based approaches in patients recovering from coronary artery bypass graft (CABG) surgery. The study involves three groups: Group A receives hospital-based yoga-integrated CR, Group B undergoes standard hospital-based CR without yoga, and Group C follows a home-based yoga-integrated CR program. The intervention includes aerobic training (walking/treadmill, cycling), yoga stretches (tree, mountain, chair, and triangle poses), breathing techniques (pranayama, bhramari), and warm-up/cool-down routines. Outcomes are assessed using the 6-Minute Walk Test (6MWT), MacNew Quality of Life Questionnaire, and inflammatory markers such as CRP and ESR. The study aims to evaluate differences in exercise capacity, quality of life, and inflammation reduction among the groups. This research emphasizes the potential benefits of combining yoga with conventional rehabilitation, particularly in resource-limited or remote settings where hospital visits are challenging. By comparing supervised and unsupervised methods, the study also highlights the feasibility of home-based programs for long-term patient care. The results may support integrating holistic practices like yoga into routine cardiac rehabilitation protocols to enhance recovery, functional capacity, and overall well-being of post-CABG patients. |