| CTRI Number |
CTRI/2025/07/091079 [Registered on: 17/07/2025] Trial Registered Prospectively |
| Last Modified On: |
17/07/2025 |
| 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
|
Comparing the effect of Exergaming vs. Real-World Sports on Lung Function. |
|
Scientific Title of Study
|
Comparing the Effect of Exergaming and Real-World Sports on Lung Function and Physical Fitness in Obese Adolescents |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sunil Choudhary |
| Designation |
MPT student |
| Affiliation |
Gurugram University |
| Address |
Department of Physiotherapy, Gurugram University, Kankrola, sector 87, Gurugram, Haryana 122505
Kankrola, Sector 87, Gurugram, Haryana 122505
Gurgaon
HARYANA
122505
India |
| Phone |
9205070705 |
| Fax |
|
| Email |
premchoudharypc888@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shefali Walia |
| Designation |
Associate Professor |
| Affiliation |
Gurugram University |
| Address |
Department of Physiotherapy, Gurugram University, Sector-87, Gurugram, Haryana
Gurgaon
HARYANA
122505
India |
| Phone |
9891770151 |
| Fax |
|
| Email |
shef0604@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sunil Choudhary |
| Designation |
MPT student |
| Affiliation |
Gurugram University |
| Address |
B-76 SFR, Mithapur Extension, Badarpur, New Delhi- 110044
South
DELHI
110044
India |
| Phone |
9205070705 |
| Fax |
|
| Email |
premchoudharypc888@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gurugram University, Sector 87, Gurugram, 122505 |
|
|
Primary Sponsor
|
| Name |
Gurugram university, Department of Physiotherapy |
| Address |
Gurugram University, Sector 87, 122505 |
| Type of Sponsor |
Research institution |
|
|
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 |
| Sunil Choudhary |
Senior Shreeram Model High School |
230, Block A, Block C, Jawahar Colony
Faridabad
HARYANA |
09205070705
premchoudharypc888@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Department of Physiotherapy, Gurugram University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
obesity |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Exergaming |
Obese adolescents will play virtual tennis and table tennis in Xbox360 for 3 days per week for 4 weeks in adolescents with obesity |
| Comparator Agent |
Real World Sports |
Obese Adolescents will play Tennis and Table Tennis 3 days per week for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
19.00 Year(s) |
| Gender |
Both |
| Details |
Adolescents with BMI ranges 25- 29.9 kg/m² will be included in the study.
Parental/guardian consent for participation |
|
| ExclusionCriteria |
| Details |
Inability to comply with the study protocol.
Participants who have regular physiotherapy/ exercise intervention.
Children with underlying cardiovascular, orthopaedic, neurological and any other health condition that would impact participation in the study protocol.
Not willing to participate in the exercise program.
Any absence from the training session.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Lung function assessment-FVC,FEV1,MVV,MIP,MEP. |
at baseline, 4 weeks and 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Physical fitness test-20MSRT |
baseline, at 4 weeks, at 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
29/07/2025 |
| 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="1"
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
|
childhood and adolescents obesity is the growing global public health concern, particular in developed nation. Define by excessive fat accumulation, obesity significantly raises risk of morbidity, psychologically and social issues, and mortality. The increasing prevalence of obesity among children in largely attributed to sedentary lifestyle in reduce physical activity. Obesity, especially in adolescents, negatively impacts respiratory function, including reduced vital capacity, FEC, FEV1 with traditional physical activity often in feasible for many obese adolescents , innovative solution are needed. Exergaming, which integrate video gaming with physical movements , has emerged as a promising intervention to promote physical activity. It is particular engaging for youth and offers an accessible, cost effective option that can improve motivation and adherence. Exergaming may also enhance lung function and overall fitness level similar to or potentially greater than real world sports, especially for those with limited access to conventional exercise. This study aim to compare the effectiveness of exergaming versus traditional sports in improving lung function and physical fitness in obese adolescents. Identifying the more impactful approach will support the development of sustainable, inclusive strategies to address adolescents obesity and its associated health complication. |