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CTRI Number  CTRI/2023/05/052330 [Registered on: 07/05/2023] Trial Registered Prospectively
Last Modified On: 07/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Single Arm Study 
Public Title of Study   To find the use of introducing physical activity along with fitness on college going students 
Scientific Title of Study   Effect of Physical Activity and Physical fitness on Academic Performance of Collegiate Potential Learners- A Pre Post Experimental Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jumana Habil Bhagat 
Designation  Post graduate student 
Affiliation  Nitte Institute of Physiotherapy 
Address  Nitte institute of physiotherapy, Nitte Deemed to be University, Nithyananda Nagar, Deralakatte, Mangaluru Department No: 20

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9980764622  
Fax    
Email  jumanabhagat17@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Yogita Hatmode  
Designation  Assistant Professor  
Affiliation  Nitte Institute of Physiotherapy 
Address  Nitte institute of physiotherapy, Nitte Deemed to be University, Nithyananda Nagar, Deralakatte, Mangaluru Department No: 20

Dakshina Kannada
KARNATAKA
575017
India 
Phone  9881981280  
Fax    
Email  yogita.hathmode@gmail.com  
 
Details of Contact Person
Public Query  
Name  Yogita Hatmode  
Designation  Assistant Professor  
Affiliation  Nitte Institute of Physiotherapy 
Address  Nitte institute of physiotherapy, Nitte Deemed to be University, Nithyananda Nagar, Deralakatte, Mangaluru Department No: 20

Dakshina Kannada
KARNATAKA
575017
India 
Phone  9881981280  
Fax    
Email  yogita.hathmode@gmail.com  
 
Source of Monetary or Material Support  
Nitte institute of physiotherapy, Nitte deemed to be university, nithyananda nagar, deralakatte, dakshina kannada, mangaluru, karnataka, 575017 
 
Primary Sponsor  
Name  Nitte deemed to be university  
Address  Nitte institute of physiotherapy, Nitte Deemed to be University, Nithyananda Nagar, Deralakatte, Mangaluru  
Type of Sponsor  Research institution and hospital 
 
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 
Jumana Habil Bhagat  Nitte institute of physiotherapy  Department no. 20, Nitte institute of physiotherapy Nitte Deemed to be University, Nithyananda Nagar, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA 		 9980764622

jumanabhagat17@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Comittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Individuals(students) 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Physical activity  Record of academic performance in the 1st internal examination of third year BPT will be collected and potential learners will be identified as per the potential learner policy of the institute. Consent will be obtained from interested potential learners and risk stratification will be done by Physical Activity Readiness Questionnaire(PARQ). Students who come under low risk category will be recruited in the study as per the inclusion criteria. The primary researcher will assess the pre physical activity and physical fitness levels using IPAQ –SF and ALPHA FIT test battery, respectively. The students will be trained by combination of aerobics and neurobics 60 minutes per day, 3 days a week for 6 weeks. During the sessions the researcher will take feedback about their eating, sleeping, screen time and study time which affects their academic performance and provide them with an information pamphlet highlighting other factors affecting their academic performance. Throughout all the sessions the researcher will encourage the students to value academic integrity. At the end of six weeks the primary researcher will measure their post physical activity and physical fitness levels using IPAQ –SF and ALPHA FIT test battery, respectively, as well as collect their academic performance of the 2nd internal examination. 
 
Inclusion Criteria  
Age From  17.00 Year(s)
Age To  24.00 Year(s)
Gender  Both 
Details  1. students who are willing to participate and adhere to the intervention program.
2. Age between 17 to 24 years old.
3. Both male and female students
4. Marks in internal examination less than 50%
5. Low risk category according to PAR-Q 
 
ExclusionCriteria 
Details  1. Students unwilling to participate. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
ALPHA FIT BATTERY TEST  Baseline and 6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
International Physical Activity Questionnaire - short form  Baseline and 6 weeks 
Academic performance of internal examination  Baseline and 6 weeks 
 
Target Sample Size   Total Sample Size="7"
Sample Size from India="7" 
Final Enrollment numbers achieved (Total)= "7"
Final Enrollment numbers achieved (India)="7" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   01/09/2023 
Date of Study Completion (India) 01/01/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   In various cross sectional studies conducted previously, it has been established that physical activity and physical fitness have a role on active health status of the students. But there is a lack of interventional studies for the same. Moreover there are currently no studies done to see the effect of physical activity and physical fitness on academic performance among the potential learners.
Hence there is a growing need to perform an intervention to evaluate the effect of physical activity and physical fitness on active health status and mental health of the students; by incorporating fun filled exercise protocols; and thereby its effect on academic performance of collegiate potential students. If a positive effect is seen in the academic performance of potential learners, then this study would stand as a basis for implementation of physical activity regime in the day to day routine of universities. 
 
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