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CTRI Number  CTRI/2025/03/082375 [Registered on: 17/03/2025] Trial Registered Prospectively
Last Modified On: 15/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   Benefits Of Online Exercise On Walking Capacity And Heart Disease Risk Score In Medically Managed Coronary Artery Disease Patients 
Scientific Title of Study   Effect Of E-Media Based Structured Exercise On Cardiovascular Risk And Functional Capacity In Conservatively Managed Coronary Artery Disease Patients 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  A shali sara helan 
Designation  MPT cardiopulmonary sciences student 
Affiliation  Sri Ramachandra Institute Of higher education and research institute 
Address  Faculty of Physiotherapy No.1 Ramachandra Nagar Porur, Chennai - 600 116 Tamil Nadu, India.

Chennai
TAMIL NADU
600116
India 
Phone  9790767363  
Fax    
Email  sherlysara50@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr T Senthil kumar 
Designation  associate professor Faculty of Physiotherapy 
Affiliation  Sri Ramachandra Institute Of higher education and research institute 
Address  Faculty of Physiotherapy Sri Ramachandra Institute Of Higher Education And Research No.1 Ramachandra Nagar Porur, Chennai - 600 116 Tamil Nadu, India.

Chennai
TAMIL NADU
600116
India 
Phone  8248172742  
Fax    
Email  senthilkumar.t@sriramachandra.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr T Senthil kumar 
Designation  associate professor Faculty of Physiotherapy 
Affiliation  Sri Ramachandra Institute Of higher education and research institute 
Address  Faculty of Physiotherapy Sri Ramachandra Institute of Higher Education And Research No.1 Ramachandra Nagar Porur, Chennai - 600 116 Tamil Nadu, India.

Chennai
TAMIL NADU
600116
India 
Phone  8248172742  
Fax    
Email  senthilkumar.t@sriramachandra.edu.in  
 
Source of Monetary or Material Support  
B1 cardiac center Sri Ramachandra Medical center, No.1 Ramachandra Nagar Porur, Chennai - 600116 Tamil Nadu, India. 
 
Primary Sponsor  
Name  A Shali Sara Helan 
Address  Sri Ramachandra Institute of Higher Education and Research Faculty of Physiotherapy No.1 Ramachandra Nagar Porur, Chennai - 600116 Tamil Nadu, India. 
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 T Senthil Kumar  Sri Ramachandra Institute Of Higher Education And Research  B1 Cardiac Center Sri Ramachandra Medical center, No.1 Ramachandra Nagar Porur, Chennai - 600116 Tamil Nadu, India.
Chennai
TAMIL NADU 
9790767363

senthilkumar.t@sriramachandra.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional Ethics Committee Sri Ramachandra Institute Of Higher Education and Research (DU) Chennai - 600116  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I21||Acute myocardial infarction,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Regular aerobic activity and counselling  walking distance for 20 minutes will be prescribed based on 6 minute walk test using the 20 minute walk distance formula it will be given for 6 weeks consisting of 20 to 30 minutes with at least 5 days per week 
Intervention  structured exercise program  current recommendation of the European society of cardiology consisting of 45-60 minutes per session with atleast 2-3 training session per week at 70-85 percentage of their maximum heart rate 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Conservatively managed CAD patients
2. Age: 35-70yrs
3. Both male and female
4. Patient who has knowledge on usage of mobile
phone and internet 
 
ExclusionCriteria 
Details  -Unstable angina
-Recent MI
-Abnormal hemodynamic status 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Other 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Framingham risk score   Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
functional capacity (6 minute walk test )  functional capacity (6 minute walk test ) 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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   N/A 
Date of First Enrollment (India)   27/03/2025 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Every year, cardiovascular illnesses result in 1.8 million fatalities. Exercise reduces mortality from cardiac causes by 15% to 31% and is recommended in class I for the care of these patients.  Gullati and colleagues verified in their investigation involving 5721 women without symptoms that, for each 1 MET rise in their ability to exercise , there was a 17% decrease in the risk of death. Traditional management strategies emphasises physical activity to mitigate cardiovascular risk factor. However adherence to exercise has various barriers such as lack of time, motivation to exercise and access to facilities. In recent years E-Media has emerged as a valuable tool for promotion health e-media intervention provide structured exercise program tailored to individual needs by synthesizing current evidences this study highlights the potential role of e-media in providing structured exercise program in the management of cardiovascular risk factor in conservatively managed CAD patient. Participants will be enrolled from the Medical Centre and G-block, SRIHER. All study participants would be briefed on the objective, process of the study and outcome, and their informed consent in writing would be collected. The cardiac risk factors will be assessed using the Framingham Risk Score and Functional capacity will be assessed utilizing the 6-minute walk test (6MWT), a standardized and widely recognized test for evaluating cardiovascular endurance and physical fitness in clinical populations will be assessed Prior to the commencment of the study and used as outcome measures. Using convinient sampling the participants will be allocated in two groups: the interventional group and the control group. For a duration of six weeks, the participants in the interventional group will receive structured exercise program according to the current recommendation of the European society of cardiology consisting of 45-60 minutes per session, with atleast 2-3 training session per week at 70-85% of their maximum heart rate. The 6-minute walk test and the Framingham risk score will be collected as a post-test following the six-week period. Results will be obtained

 
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