| CTRI Number |
CTRI/2019/08/020640 [Registered on: 09/08/2019] Trial Registered Prospectively |
| Last Modified On: |
01/08/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Does the repeated sprinting exercises produce the impact on brain executive function in sedentary individuals. |
|
Scientific Title of Study
|
Effect of repeated sprinting exercises on brain executive function in sedentary individuals. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shaffi Bakash |
| Designation |
PG Student |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
Room No: 1
SRM College of Physiotherapy
SRM Institute of Science and Technology
Kattankulathur
Kancheepuram (DT)
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9944107102 |
| Fax |
|
| Email |
shafismart77@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ayyappan Jayavel |
| Designation |
Associate Professor |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
Room No: 1
SRM College of Physiotherapy
SRM Institute of Science and Technology,
Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9994948597 |
| Fax |
|
| Email |
ayyappanpt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ayyappan Jayavel |
| Designation |
Associate Professor |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
Room No:1
SRM College of Physiotherapy
SRM Institute of Science and Technology,
Kattankulathur
Coimbatore
TAMIL NADU
603203
India |
| Phone |
9994948597 |
| Fax |
|
| Email |
ayyappanpt@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mr.Shaffi Pakash,
Room np:1
SRM College of Physiotherapy
SRM IST |
|
|
Primary Sponsor
|
| Name |
MrShaffi Pakash |
| Address |
Room No: 1
SRM College of Physiotherapy
SRM IST
kattankulathur |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| MrJAyyappan |
SRM College of Physiotherapy |
No.1, SRM College of Physiotherapy,
SRM Institute of Science and Technology,
Kattankulathur
Kancheepuram
TAMIL NADU |
9994948597
ayyappanpt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Intitutional Ethical Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Sedentary population (The subjects those who walk less than 5000 steps per day comes under sedentary population. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
N/A |
N/A |
| Intervention |
Repeated Sprinted training |
it is a form of high intensity exercise done in high intensity with equal amount of rest and intrval for 5 min |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Male |
| Details |
Sedentary population (The subjects those who walk <5000 steps/day comes under sedentary population). |
|
| ExclusionCriteria |
| Details |
Recent lower limb injury
Cardiac ailments
History of Recent fracture
History of Recent Surgery
Subject who are not willing
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Blood lactate measurement
Rate of Perceived Exertion
Felt Arousal scale
Stroop Color & Word Test
|
Pre experiment and post experiment
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
Target Sample Size
|
Total Sample Size="166"
Sample Size from India="166"
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)
|
20/08/2019 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
According to the criteria the subjects will be selected and informed consent form will be obtained from them. The selected subjects will be evaluated Pre and post Test with the outcome measures and high intensity exercises will be given followed by outcome measures will be measured • Blood lactate measurement • RPE (Borg scale) (Post Test only) • Felt arousal scale • The Stroop Color and Word Test (SCWT)
|