| CTRI Number |
CTRI/2025/08/093135 [Registered on: 18/08/2025] Trial Registered Prospectively |
| Last Modified On: |
17/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Assessing the effectiveness of virtual reality in motivating towards healthy lifestyle habits habits among people at risk of coronary artery disease- A experimental study |
|
Scientific Title of Study
|
Assessing the effectiveness of virtual reality in enhancing cardiovascular health and motivation towards healthy lifestyle habits in the people at risk of developing coronary artery disease- A experimental study |
| Trial Acronym |
Experimental study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aditi Watwe |
| Designation |
Post Graduate |
| Affiliation |
Dayananda Sagar College of Physiotherapy Dayananda Sagar University |
| Address |
Block number F, Dayananda Sagar University Devarakaggalahalli, Harohalli Kanakapura Road, Dt, Ramanagara, Karnataka 562112, India
Bangalore Rural
KARNATAKA
562112
India |
| Phone |
6364471204 |
| Fax |
|
| Email |
watweaditi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR. Shrihari Sharma |
| Designation |
PhD |
| Affiliation |
Dayananda Sagar College of Physiotherapy Dayananda Sagar University |
| Address |
Block number F, Dayananda Sagar University Devarakaggalahalli, Harohalli Kanakapura Road, Dt, Ramanagara, Karnataka 562112, India
Bangalore Rural
KARNATAKA
562112
India |
| Phone |
9886040520 |
| Fax |
|
| Email |
srihari-physio@dsu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Aditi Watwe |
| Designation |
Post Graduate |
| Affiliation |
Dayananda Sagar College of Physiotherapy Dayananda Sagar University |
| Address |
Block number F, Dayananda Sagar University Devarakaggalahalli, Harohalli Kanakapura Road, Dt, Ramanagara, Karnataka 562112, India
Bangalore Rural
KARNATAKA
562112
India |
| Phone |
6364471204 |
| Fax |
|
| Email |
watweaditi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dayananda sagara college of physiotherapy Devarakaggalahalli, Harohalli Kanakapura Road, Dt, Ramanagara, Karnataka 562112, India |
|
|
Primary Sponsor
|
| Name |
Dayananda Sagar University |
| Address |
Dayananda Sagar University Devarakaggalahalli, Harohalli
Kanakapura Road, Dt, Ramanagara,562112 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| 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 |
| DrShrihari Sharma |
College of physiotherapy Dayananda Sagar University |
Block number F, Department of cardiopulmonary sciences Dayananda sagar university, devarakaggalahalli, harohalli, kanakpura road ramanagara,Dt., Karnataka-562112
Bangalore
KARNATAKA |
9886040520
srihari-physio@dsu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
People at risk of Coronary Artery Disease |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Virtual Reality |
Participants will be introduced to Virtual Reality head mounted device and will be prepared for operating the device.
Participants then will be shown various types of motivational videos which will help themselves to motivate about the exercise and healthy lifestyle.
The virtual reality therapy module will be consist of 7days of sessions of 15minutes per day. The pre and post therapy recording on situational motivation scale. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Individuals at low and moderate risk of developing coronary artery disease.
Age above 18years and above.
Individual who can read and understand English language.
Written informed consent form.
Individuals who are willing to participate as volunteers in the study.
|
|
| ExclusionCriteria |
| Details |
Individuals who are visually impaired.
Individuals using hearing aid.
Individuals who are not cognitively sound.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Situational Motivation Scale |
2
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
28/08/2025 |
| 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="6"
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
|
Coronary artery disease (CAD), caused by the buildup of atherosclerotic plaques in the heart’s arteries, is a major global health issue, leading to over 7 million deaths annually. In 2022, there were an estimated 315 million cases worldwide, with rising prevalence in India—especially among younger individuals and urban populations. Modifiable risk factors like poor diet, physical inactivity, smoking, and obesity play a significant role in CAD development, while non-modifiable factors include age, sex, and genetics. Traditional health education methods often fall short in motivating lasting lifestyle changes. Emerging technologies like Virtual Reality (VR) offer immersive, personalized experiences that can improve awareness, motivation, and engagement with healthy behaviors. VR’s potential in promoting prevention, especially among high-risk groups, highlights its value in reducing the burden of CAD and improving quality of life through early intervention and behavior change. |