FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/10/059287 [Registered on: 30/10/2023] Trial Registered Prospectively
Last Modified On: 09/10/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Evaluation Of Cognition of Physically Inactive And Active Young subjects Using Stroop test –A Case Control Study 
Scientific Title of Study   EVALUATION OF COGNITIVE INTERFERENCE BETWEEN PHYSICALLY INACTIVE AND ACTIVE YOUNG INDIVIDUALS USING STROOP TEST –A CASE CONTROL 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  Akshata Anil Maha 
Designation  Intern 
Affiliation  Dr. Ulhas Patil college of physiotherapy  
Address  NH 06 Gat No 57 1 Khirdi ShivarTal And Dist Jalgaon

Jalgaon
MAHARASHTRA
42530
India 
Phone  7507995790  
Fax    
Email  akshata1704maha@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pradnya Mahajan  
Designation  Assistant professor  
Affiliation  Dr Ulhas Patil college of physiotherapy  
Address  NH 06 Gat No 57 Khirdi ShivarTal And Dist Jalgaon

Jalgaon
MAHARASHTRA
42530
India 
Phone  9284034348  
Fax    
Email  ppradz1816@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Pradnya Mahajan  
Designation  Assistant professor  
Affiliation  Dr Ulhas Patil college of physiotherapy  
Address  NH 06 Gat No 57 Khirdi ShivarTal And Dist Jalgaon


MAHARASHTRA
42530
India 
Phone  9284034348  
Fax    
Email  ppradz1816@gmail.com  
 
Source of Monetary or Material Support  
Dr.Ulhas Patil College of Physiotherapy  
 
Primary Sponsor  
Name  Akshata Maha 
Address  NH 06, Gat No. 57 1, Khirdi Shivar, Tal And Dist Jalgaon 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pradnya Mahajan   Dr. Ulhas Patil college of physiotherapy   NH 06, Gat No. 57 1, Khirdi Shivar, Tal And Dist Jalgaon
Jalgaon
MAHARASHTRA 
9284034348

ppradz1816@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee of Dr. Ulhas Patil college of physiotherapy   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy active and inactive individuals  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  a) Inclusion criteria for Case
1. Literate
2. IPAQ score <600 MET min/week
3. Age 18-25 year old
b) Inclusion criteria for Control
1. Literate
2. IPAQ score >600 MET min/week
3. Age 18-25 year old
 
 
ExclusionCriteria 
Details 
1) Thyroid
2) Obesity
3) Diabetes mellitus
4) Hypertension
5) any other co morbidities  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Stroop test  Stroop test 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="56" 
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)   30/11/2023 
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="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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   Ethical clearance will be obtained from Institutional Ethical Committee & Principal of
Dr. Ulhas patil college of physiotherapy. A written informed consent form will be
obtained from subjects who are willing to participate. Subject will be screened
according to inclusion and exclusion criteria. The aim of the study and its objective will
be explained to willing participants. Selected participants demographics details
outcome measures will be recorded. To determine the weekly Physical Activity(PA) of
Participants Short version of IPAQ will be used. The participants will be asked about
moderate intensity active time, vigorous intensity active time and walking time. The
participants METs will be calculated according to the IPAQ guidelines as follows:
 Walking MET – minutes/week = 3.3 ∗ walking minutes ∗ walking days
 Moderate MET−minutes/week = 4.0∗moderate−intensity activity
minutes∗moderate−intensity days
 Vigorous MET− minutes/week = 8.0∗vigorous−intensity activity
minutes∗vigorous−intensity days
 Total physical activity MET−minutes/week = sum of
walking+moderate+vigorous MET−minutes/weekscore
In IPAQ guidelines individuals scoring MET weekscore <600 METs /week are labelled
as Physically Inactive while >600METs/week are labelled as Physically Active. On this
basis the participants will be divided into two groups according to the total metabolic
equivalent of task (MET) in a week .
1. Individuals with MET-min/week <600 (CASE)
2. Individuals with MET-min/week >600 (CONTROL)
After screening and dividing the subjects in two groups, Stroop Word Colour Test
(SCWT) will be administered amongst the two of them as follows.
Name of the participant and time of test will be noted on the data sheet. Task will be
determined and planned. Two of them represent the “congruous condition” in which participants are required to read names of colors (henceforth referred to as color
words) printed in black ink (W) and name different color patches (C).Conversely, in the third table, named color-word (CW) condition, color-words are
printed in an inconsistent color ink (for instance the word “red” is printed in green ink).
Thus, in this incongruent condition, participants are required to name the color of the
ink instead of reading the word. In other words, the participants are required to perform
a less automated task (i.e., naming ink color) while inhibiting the interference arising
from a more automated task. For eg. In congruous condition some random set of
alphabets will be displayed ,and participants will be instructed to “say the name of
colour, as fast as possible and not to read the word” in this there will be no conflicting
information to the brain that brain have to filter out.Each set of word will consist of 30 unique word colour combinations. As the participant
completes the task,tally marks will be given for each error. If the participant makes
more than 3 errors the task will be stopped and begin again. All the observations and
recordings will be noted down in data sheet.
In this method, the number of items correctly named in 45 s in each conditions is
calculated (i.e., W, C, CW). Then the predicted CW score (Pcw) is calculated using
the following formula:
Pcw = 45/{((45 × W) + (45 × C))/(W × C)}
equivalent to:
 Pcw = (W × C)/(W + C)
Then, the Pcw value is subtracted from the actual number of items correctly named in
the incongruous condition(CW)
i.e. IG = CW − Pcw
this procedure allows to obtain an interference score (IG) based on the performance
in both W and C conditions. Thus, a negative IG value represents a pathological ability
to inhibit interference, where a lower score means greater difficulty in inhibiting interference.
 
Close