| 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
|
|
|
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
|
|
|
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
|