| CTRI Number |
CTRI/2025/11/097601 [Registered on: 18/11/2025] Trial Registered Prospectively |
| Last Modified On: |
18/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
The study is about how playing fun moving games with special glasses called virtual reality glasses can help people heavier in weight move it can also help lower body fat and improve body mass index which shows if a persons weight is healthy for their height |
|
Scientific Title of Study
|
Effect of virtual reality exercise program on functional capacity and bmi in obese individuals |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Komal Late |
| Designation |
PG Student |
| Affiliation |
Parul Institute of Physiotherapy |
| Address |
Parul Institute of Physiotherapy
Parul University Post Limda Taluka Waghodiya District Vadodara 391760
Vadodara
GUJARAT
391760
India |
| Phone |
8657158284 |
| Fax |
|
| Email |
komallate19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Advita Deepak |
| Designation |
Associate Professor |
| Affiliation |
Parul Institute of Physiotherapy |
| Address |
Parul Institute of Physiotherapy
Parul University Post Limda Taluka Waghodiya District Vadodara 391760
Vadodara
GUJARAT
391760
India |
| Phone |
8320655918 |
| Fax |
|
| Email |
advita.deepak@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Komal Late |
| Designation |
PG Student |
| Affiliation |
Parul Institute of Physiotherapy |
| Address |
Parul Institute of Physiotherapy
Parul University Post Limda Taluka Waghodiya District Vadodara 391760
Vadodara
GUJARAT
391760
India |
| Phone |
8657158284 |
| Fax |
|
| Email |
komallate19@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul university vadodara gujurat 391760
parul institute of physiotherapy |
|
|
Primary Sponsor
|
| Name |
Parul Institute Of Physitherapy |
| Address |
Parul Institute of Physiotherapy
Parul university Limda Waghodiya Vadodara Gujurat 391760 |
| Type of Sponsor |
Private medical college |
|
|
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 komal late |
Parul institute of physiotherapy |
parul institute of physiotherapy parul university pg class 401 4th floor
Vadodara
GUJARAT |
8657158284
komallate19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Parul University Institutional Ethics Committee for Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Nil |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group 1 virtual reality exercise
|
group 1 virtual reality exercise is a game based exercise program for 20 minutes
|
| Comparator Agent |
group 2 conventional exercise |
group 2 receives treadmill walking for 20 minutes both groups receive a cool down and warm up for 5 minutes each |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Age group 18 to 30 year
both genders are included
individuals with body mass index greater than 30 kg per m2
voluntary participation and ability to communicate effectively
subjects who are able to understand and follow simple verbal instructions |
|
| ExclusionCriteria |
| Details |
Presence of visual acuity deficit
severe cardiovascular musculoskeletal or respiratory conditions that contraindicate physical activity
significant perceptual cognitive impairment
pregnant women |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Functional capacity and body mass index |
6 weeks
6 days per week for 30 minutes per day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
05/12/2025 |
| 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
|
Need of the study Obesity significantly reduces functional capacity and increases the risk of comorbidities Traditional exercise programs often lack engagement and adherence virtual reality based exercise offers an interactive and motivating alternative that may enhance participation and outcomes Purpose of the study To evaluate the effectiveness of virtual reality exercise programs on improving functional capacity and reducing body mass index in obese individuals |