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CTRI Number  CTRI/2024/01/061301 [Registered on: 09/01/2024] Trial Registered Prospectively
Last Modified On: 29/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effects of e-Media Supported Exercise Based Phase II Cardiac Rehabilitation in Heart Bypass Surgery Patients- A Randomized Controlled Trial 
Scientific Title of Study   Effects of e-Media Supported Exercise Based Phase II Cardiac Rehabilitation in Coronary Artery Bypass Surgery Patients- A Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Manoj Kumar R 
Designation  Post Graduate Student-MPT Cardiopulmonary Science 
Affiliation  Sri Ramachandra Institute of Higher Education and Research 
Address  140,C1 Raksha Flats, Baba Nagar 3rd Main Road, Villivakkam , Chennai
No.1 Mount Poonamalle Road, Sri Ramachandra Nagar, Iyyappanthangal, Chennai
Chennai
TAMIL NADU
600049
India 
Phone  7904670448  
Fax    
Email  manojkumarmpt1999@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Senthil Kumar T 
Designation  Associate Professor 
Affiliation  Sri Ramachandra Institute of Higher Education and Research 
Address  Sri Ramachandra Faculty of Physiotherapy,2nd Floor,No.1 Mount Poonamalle Road, Ramachandra Nagar, Iyyappanthangal, Chennai

Chennai
TAMIL NADU
600116
India 
Phone  8248172742  
Fax    
Email  senthilkumar.t@sriramachandra.edu.in  
 
Details of Contact Person
Public Query  
Name  Manoj Kumar R 
Designation  Post Graduate Student-MPT Cardiopulmonary Science 
Affiliation  Sri Ramachandra Institute of Higher Education and Research 
Address  140,C1 Raksha Flats, Baba Nagar 3rd Main Road, Villivakkam , Chennai

Chennai
TAMIL NADU
600049
India 
Phone  7904670448  
Fax    
Email  manojkumarmpt1999@gmail.com  
 
Source of Monetary or Material Support    
Primary Sponsor  
Name  Nil 
Address  Nil 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Senthil Kumar T  Sri Ramachandra Institute of Higher Education and Research  Sri Ramachandra Faculty of Physiotherapy,2nd Floor,No.1 Mount Poonamalle Road, Ramachandra Nagar, Iyyappanthangal, Chennai
Chennai
TAMIL NADU 		 8248172742

senthilkumar.t@sriramachandra.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee for Students Project  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I219||Acute myocardial infarction, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Exercise Training  3 Months of e-Media supported Exercise Training that includes : 1st Month-Aerobic training; 2nd Month-Aerobic and Resistance training; 3rd Month-Aerobic, Resistance and Flexibility training; Frequency- 5 days per week; Total Duration - 12 weeks 
Comparator Agent  Usual Care   Control Group will be given usual care including Counselling and Education on Lifestyle Modification. The Pre Test data will be collected at the time of patient discharge. The Post Test data will be collected after 12 weeks from the time of patient discharge. No follow up would be done in between this 12 weeks.  
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Adult patients (age: 35 to 65 years) who have undergone Coronary Artery Bypass
Grafting (CABG) surgery
2. Patients in the Phase II cardiac rehabilitation stage, indicating that they have completed
10
the initial recovery period after surgery and are ready to engage in exercise-based
rehabilitation.
3. Patients who are deemed suitable for home-based cardiac rehabilitation- Low cardiac
risk stratification
4. Patients with access to electronic media devices (e.g., computer, smartphone, tablet)
and internet connectivity.
5. Patients who can understand and communicate effectively in the language used for the
study materials and assessments. 
 
ExclusionCriteria 
Details  1. Patients with severe cognitive impairments or mental health conditions that may hinder
their ability to engage in the cardiac rehabilitation program or provide informed consent.
2. Patients with significant comorbidities or medical conditions that would limit their
ability to safely participate in a home-based cardiac rehabilitation program
3. Patients with contraindications to exercise or significant medical conditions that may
affect their ability to safely participate in the rehabilitation program.
4. Patients who have participated in a structured cardiac rehabilitation program within the
past six months.
5. Patients who are unable or unwilling to comply with the study requirements or follow
the assigned e-media supported rehabilitation program. 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Other 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Functional Capacity-6 minute walk Test
2.Rating of Perceived Exertion-BORG scale 		 12 Weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1.Quality of Life- WHOQOL-BREF
2.Physical Activity-GPAQ 		 12 Weeks 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   22/01/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
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   The RCT study is being conducted for the PG dissertation for the partial fulfillment of the course Masters of Physiotherapy. The subjects are post Coronary Artery bypass surgery patients. The  subjects will be provided with  proper concern for the study. There will be two groups where subjects will be assigned randomly to one is experimental and the other is  control. The experimental group will receive the intervention that is exercises in this study for phase 2 cardiac rehabilitation through e-media. The interventions used in the study are approved by the doctors and the physiotherapist of SRMC. The control group will receive usual care. Pre and post test assessment will be done and the results will be analyzed and interpreted. 
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