| CTRI Number |
CTRI/2024/08/072231 [Registered on: 09/08/2024] Trial Registered Prospectively |
| Last Modified On: |
05/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Smartphone use] |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Effect of mental fatigue induced by smartphones on physical and technical performance in basketball players. |
|
Scientific Title of Study
|
Effect of smartphone induced mental fatigue on physical and technical performance variables in basketball players. |
| 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 Vikram Singh Yadav |
| Designation |
Assistant Professor |
| Affiliation |
College of Physiotherapy, Pt. B. D. Sharma Post Graduate Institute of Medical Sciences, Rohtak |
| Address |
Faculty room, E-block, Department of Physiotherapy College of Physiotherapy, PGIMS, Rohtak Haryana 124001 India
Rohtak
HARYANA
124001
India |
| Phone |
9466441234 |
| Fax |
|
| Email |
vikramsinghyadav@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Manisha |
| Designation |
PG student |
| Affiliation |
College of Physiotherapy, Pt. B. D. Sharma Post Graduate Institute of Medical Sciences, Rohtak |
| Address |
PG clinic, E-block, Department of Physiotherapy College of Physiotherapy, PGIMS, Rohtak Haryana 124001 India
Rohtak
HARYANA
124001
India |
| Phone |
7027507943 |
| Fax |
|
| Email |
sourabhathwal1122@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vikram Singh Yadav |
| Designation |
Assistant Professor |
| Affiliation |
College of Physiotherapy, Pt. B. D. Sharma Post Graduate Institute of Medical Sciences, Rohtak |
| Address |
Faculty room, E-block, Department of Physiotherapy College of Physiotherapy, PGIMS, Rohtak Haryana 124001 India
Rohtak
HARYANA
124001
India |
| Phone |
9466441234 |
| Fax |
|
| Email |
vikramsinghyadav@gmail.com |
|
|
Source of Monetary or Material Support
|
| College of Physiotherapy, Pandit B.D. Sharma Post Graduate Institute of Medical Sciences, UHS, Rohtak Haryana 124001 India |
|
|
Primary Sponsor
|
| Name |
College of Physiotherapy Pt. B. D. Sharma Post Graduate Institute of Medical Sciences, Rohtak |
| Address |
College of Physiotherapy, Pandit B.D. Sharma Post Graduate Institute of Medical Sciences, UHS, Rohtak Haryana 124001 India |
| Type of Sponsor |
Government 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 Vikram Singh Yadav |
College of Physiotherapy, Pt. B. D. Sharma Post Graduate Institute of Medical Sciences, Rohtak |
College of Physiotherapy, Pandit B.D. Sharma Post Graduate Institute of Medical Sciences, UHS, Rohtak Haryana 124001 India
Rohtak
HARYANA |
9466441234
vikramsinghyadav@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee Pt. B. D. Sharma Post Graduate Institute of Medical Sciences, UHS, Rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Sports Person |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
playing videogames |
PLAY VIDEO GAME on smartphone(visit 2) |
| Intervention |
Smartphone use |
SOCIAL MEDIA use on smartphone(visit 1)
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Male |
| Details |
An athlete within the age group of 18-35 years.
Only male basketball players will be included in the study.
Participants will be free of any cardiopulmonary disorder and metabolic disease and visual disorder. |
|
| ExclusionCriteria |
| Details |
An athlete who smokes, is an alcoholic and uses an ergogenic aids.
An athlete who is having cardiopulmonary and metabolic disease and visual disorder.
An athlete who suffered an injury in the last three months. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Explosive strength of upper lmb
Explosive strength of lower limb
Agility t-test
Dynamic balance
Basketball shooting accuracy
Dribble deficit |
At baseline (visit 1)
Social media use on smartphone(visit 2)
Play videogames on smartphone(visit 3) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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)
|
30/08/2024 |
| 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
|
The study aims to evaluate the level of mental fatigue due to smartphone use and its effect on technical and physical performance variables of 25 male basketball players. Mental fatigue will be evaluated in two different conditions on smartphones. Three visits are scheduled for assessment visit 1- baseline parameters, visit 2 condition I on smartphone and visit 3 condition II on smartphone. After measurement data will be analysed and appropriate software will be used to compare pre post intervention and within groups. |