| CTRI Number |
CTRI/2023/01/048737 [Registered on: 04/01/2023] Trial Registered Prospectively |
| Last Modified On: |
24/05/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [WARM-UP PROTOCOL FOR SPORTSPERSONS ] |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Effect of warm-up before exercise or practice, on cognitive function such as accuracy in games, reaction time before opponents in sportspersons |
|
Scientific Title of Study
|
A RANDOMISED CONTROL TRIAL TO DESCRIBE THE DISTRIBUTION OF COGNITIVE FUNCTION MEASURED BY MOTOR PRAXIS TASK, PSYCHOMOTOR VIGILANCE TASK IMMEDIATELY AFTER GENERAL WARM-UP AND SPORT SPECIFIC WARM-UP PROTOCOL IN SELECTED SPORTSPERSONS: A PILOT STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ARIVARASAN S |
| Designation |
PG RESIDENT SPORTS MEDICINE |
| Affiliation |
ARMED FORCES MEDICAL COLLEGE |
| Address |
DEPT OF SPORTS MEDICINE, ARMED FORCES MEDICAL COLLEGE, PUNE
ARMED FORCES MEDICAL COLLEGE, PUNE
Pune
MAHARASHTRA
411040
India |
| Phone |
9003221137 |
| Fax |
|
| Email |
arivarasan1990@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Col Dr Karuna Datta |
| Designation |
Professor and Head of Department |
| Affiliation |
ARMED FORCES MEDICAL COLLEGE |
| Address |
DEPT OF SPORTS MEDICINE, ARMED FORCES MEDICAL COLLEGE, PUNE
ARMED FORCES MEDICAL COLLEGE, PUNE
Pune
MAHARASHTRA
411040
India |
| Phone |
9003221137 |
| Fax |
|
| Email |
karunadatta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ARIVARASAN S |
| Designation |
PG RESIDENT SPORTS MEDICINE |
| Affiliation |
ARMED FORCES MEDICAL COLLEGE |
| Address |
DEPT OF SPORTS MEDICINE, ARMED FORCES MEDICAL COLLEGE, PUNE
ARMED FORCES MEDICAL COLLEGE, PUNE
Pune
MAHARASHTRA
411040
India |
| Phone |
9003221137 |
| Fax |
|
| Email |
arivarasan1990@gmail.com |
|
|
Source of Monetary or Material Support
|
| Armed Forces Medical College
Solapur- Pune Highway, Near Race course, Wanowrie, Pune, Maharashtra - 411040 |
|
|
Primary Sponsor
|
| Name |
ARMED FORCES MEDICAL COLLEGE |
| Address |
ARMED FORCES MEDICAL COLLEGE PUNE |
| 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 |
| SQN LDR DR ARIVARASAN S |
ARMED FORCES MEDICAL COLLEGE |
Dept of Sports Medicine,
ARMED FORCES MEDICAL COLLEGE, PUNE
Pune
MAHARASHTRA |
9003221137
arivarasan1990@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, ARMED FORCES MEDICAL COLLEGE, PUNE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
SELECTED SPORTSPERSONS WITHOUT ANY DISEASE/ DISABILITY and MUSCULOSKELETAL INJURIES |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Protocol1 |
General warm-up protocol for 15 minutes duration involves
Jogging in comfortable pace for a duration of 15 minutes |
| Intervention |
Protocol2 |
Sports specific warm-up protocol of 15 minutes duration including
Jogging
Activation & mobilization exercises
Potentiation exercises |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Male |
| Details |
Volunteering sportspersons who are falling in age group between 15-35years of age and active in particular sports for at least more than 6 months in sports institute of western Maharashtra |
|
| ExclusionCriteria |
| Details |
Diagnosed with any disease/ disorder with/without treatment
Suffering from any musculoskeletal injury or undergoing any rehabilitation
Unwilling subjects |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcomes measured are Accuracy
Reaction time
using Motor Praxis Task and Psychomotor Vigilance task using a validated software named Joggle Research application for cognitive function assessment |
Baseline as soon as recruited,
second time on 1st day. third time after 48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of false starts in computerized psychomotor vigilance task after sports specific warm up in comparison with general warm up |
on Day 1 and after 48 hours |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "28"
Final Enrollment numbers achieved (India)="28" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/01/2023 |
| Date of Study Completion (India) |
31/03/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/03/2023 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Sent for publication |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [arivarasan1990@gmail.com].
- For how long will this data be available start date provided 05-01-2023 and end date provided 30-06-2023?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
Modification(s)
|
Athletes falling in inclusion criteria were taken for the study after written informed consent and description of the study. Their pre-warm-up heart rate and cognitive function were taken which is considered as baseline for both the warm-up protocol to be performed. Then the participants were randomized to perform warm-up protocol 1 and 2 on two separate occasions, 48 hours apart to allow the participants to recover.
Warm-up protocol 1 - Athletes were asked to do warm up in their comfortable pace of jogging for 15 minutes. Post-warm-up heart rate was measured and the cognitive testing was done immediately after warm-up.
Warm-up protocol 2 - Athletes were asked to do sports-specific warm-up protocol created which included jogging, activation and mobilization of major muscle groups, and sports-specific movement patterns including plyometric movements for a total of 15 minutes. Post-warm-up heart rate was measured and the cognitive testing was done immediately post warm-up.
Cognitive testing was done using the Joggle research application, a validated computerized neurocognitive assessment tool that had the Motor Praxis task, validated by Gur RC et al 2001 and the Psychomotor Vigilance task, validated by Basner et al 2011 for determining the accuracy and reaction time of the participants.
The results of accuracy and reaction time after both the warm-up protocol was analyzed using standard statistical software and found that both the accuracy and reaction time improved after sports-specific warm-up. |