| CTRI Number |
CTRI/2025/09/094229 [Registered on: 04/09/2025] Trial Registered Prospectively |
| Last Modified On: |
03/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Video game–based exercise and brain games help young adults improve their thinking and focus |
|
Scientific Title of Study
|
Effect of Exergaming vs Neurobic exercise on Executive function in young adult - A Compartive study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Samruddhi Kulkarni |
| Designation |
PG student |
| Affiliation |
Parul institute of physiotherapy |
| Address |
Parul University 409 Electrotherapy lab P O Limda Tal Waghodia Dist Vadodara 391760 Gujarat State India
Vadodara
GUJARAT
391760
India |
| Phone |
8446531660 |
| Fax |
|
| Email |
samruddhik304@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Joyal Tejpal |
| Designation |
Assistant professor |
| Affiliation |
Parul Institute of Physiotherapy |
| Address |
Parul University 409 Electrotherapy lab P O Limda Tal Waghodia Dist Vadodara 391760 Gujarat State India
Vadodara
GUJARAT
391760
India |
| Phone |
9909981454 |
| Fax |
|
| Email |
joyal.tejpal25384@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Samruddhi Kulkarni |
| Designation |
PG student |
| Affiliation |
Parul Institute of Physiotherapy |
| Address |
Parul University P O Limda Tal Waghodia Dist Vadodara 391760 Gujarat State India
Vadodara
GUJARAT
391760
India |
| Phone |
8446531660 |
| Fax |
|
| Email |
samruddhik304@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [] |
|
|
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 |
| Samruddhi Kulkarni |
Parul Sevashram Hospital |
Parul University P O Limda Tal Waghodia Dist Vadodara 391760 Gujarat State India neurophysiotherpy department Room no 201
Vadodara
GUJARAT |
8446531660
samruddhik304@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 |
Young Adults |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Exergaming |
Exergaming (exercise + gaming) involves playing video games that require physical movement to control gameplay. It combines physical exercise with cognitive engagement through interactive tasks, visual feedback, and decision-making. Enhances attention, working memory, planning, and problem-solving through real-time decision-making.
4 weeks of intervention,alternate day in a week for 45 minutes |
| Comparator Agent |
Neurobic exercise |
Neurobic exercises are brain exercises that stimulate neurons by using unusual or novel sensory and cognitive activities. It works on neuroplasticity by creating a new neural connections and strengthening existing ones. Improves memory, flexibility, and attention control and enhances creativity and problem-solving by forcing the brain to think in new ways.
4 weeks of intervention, alternate days in a week for 45 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Age -18 to 25 yrs
No history of significant neurological or psychiatric disorders
No medical conditions that could impair cognitive performance (e.g.,
severe cardiovascular disease, uncontrolled diabetes)
No current use of medication that could impair cognitive function.
Willing to participate.
Participants who are not included in any other study.
Executive skill questionnaire scores below 40. |
|
| ExclusionCriteria |
| Details |
Individuals with a history of neurological disorders.
Participants who currently abuse drugs or alcohol, or those who are on
medications that affect cognition.
Individuals with physical disabilities,
Current participation in any other exercise program or cognitive training
program. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Executive Skill Questionnarie |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adult Executive Functioning Inventory |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
16/10/2025 |
| 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="1"
Months="0"
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
|
Executive function (EF) refers to a set of higher-level cognitive skills that
enable individuals to plan, make decisions, solve problems, manage time
effectively, and engage in goal-directed behavior. It includes key cognitive
abilities such as working memory, cognitive flexibility, inhibitory
control, and task switching. While research on interventions for cognitive enhancement in older
populations is well-established, relatively fewer studies focus on
enhancing executive function in young adults. As young adults are often faced with cognitive challenges, such as
managing multiple tasks, making complex decisions, and adapting to new
environments, neurobic exercises may serve as an effective way to enhance
executive function. While research has established that both physical exercise and cognitive
training independently contribute to improved cognitive function, there is
a lack of comparative studies. |