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CTRI Number  CTRI/2018/07/014921 [Registered on: 17/07/2018] Trial Registered Prospectively
Last Modified On: 13/07/2018
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Correlational 
Study Design  Cluster Randomized Trial 
Public Title of Study   Do physical fitness,exams marks and the brain functioning, of a school going child, depend on each other? 
Scientific Title of Study   Association of physical fitness, academic performance and cognitive functions in adolescent urban school children- A Correlational study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sonam Jain 
Designation  MPTh sudent 
Affiliation  Sancheti Institute College of Physiotherapy 
Address  Sancheti Healthcare Academy, Thube Park, Shivajinagar, Pune

Pune
MAHARASHTRA
411005
India 
Phone  020-25539393  
Fax    
Email  dr.sonam.jain01@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Apurv Shimpi 
Designation  Professor 
Affiliation  Sancheti Institute College of Physiotherapy 
Address  Sancheti Healthcare Academy, Sancheti Institute College of Physiotherapy, 11/12 1st Floor Community Physiotherapy Deaprtment, Thube Park Shivajinagar, Pune

Pune
MAHARASHTRA
411005
India 
Phone  020-25539393  
Fax    
Email  apurv008@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sonam Jain 
Designation  MPTh sudent 
Affiliation  Sancheti Institute College of Physiotherapy 
Address  Sancheti Healthcare Academy, Thube Park, Shivajinagar, Pune

Pune
MAHARASHTRA
411005
India 
Phone  020-25539393  
Fax    
Email  dr.sonam.jain01@gmail.com  
 
Source of Monetary or Material Support  
Dr. Sonam Jain 
 
Primary Sponsor  
Name  Dr Sonam Jain 
Address  Sancheti Healthcare Academy, Sancheti Institute College of Physiotherapy, 11/12 1st Floor Community Physiotherapy Deaprtment, Thube Park Shivajinagar, Pune 
Type of Sponsor  Other [self] 
 
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 Sonam Jain  Sancheti Institute College of Physiotherapy  Sancheti Healthcare Academy, Sancheti Institute College of Physiotherapy, 11/12 1st Floor Community Physiotherapy Deaprtment, Thube Park Shivajinagar, Pune
Pune
MAHARASHTRA 
9763343187

dr.sonam.jain01@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
sancheti institute for orthopaedics and rehabilitationr  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy adolescents 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  14.00 Year(s)
Gender  Both 
Details  1. Children from 7th to 9th standard (12-14 years)
2. Both males and females 
 
ExclusionCriteria 
Details  Children with any known cardiovascular, musculoskeletal or neurological disorder 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Aerobic capacity: PACER test
2. Anthropometric measures: Height, weight and BMI
3. Academic performance: Exam marks
4. Cognitive function: Stroop test
5. Socioeconomic status: Modified Kuppuswamy scale
6. Lifestyle habits: Questionnaire 
1. Aerobic capacity: PACER test- 20 mins
2. Anthropometric measures: Height, weight and BMI- 10 mins
3. Academic performance: Exam marks- 10 mins
4. Cognitive function: Stroop test- 5 mins
5. Socioeconomic status: Modified Kuppuswamy scale- 5 mins
6. Lifestyle habits: Questionnaire- 5 mins 
 
Secondary Outcome  
Outcome  TimePoints 
1. Anthropometric measures: Height, weight and BMI
2. Socioeconomic status: Modified Kuppuswamy scale
3. Lifestyle habits: Questionnaire 
1. Anthropometric measures: Height, weight and BMI- 10 mins
2. Socioeconomic status: Modified Kuppuswamy scale- 5 mins
3. Lifestyle habits: Questionnaire- 5mins 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   23/07/2018 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

BACKGROUND: Physical fitness in children and adolescents determines their health status and predicts if they are prone to co-morbidities that may extend in adulthood. The initial literature on the benefits of being physically fit were limited to the musculoskeletal and cardiorespiratory systems. The recent trends have shown that physical fitness has an effect on the neurological system as well. Physical inactivity, childhood obesity and sedentary life in school going age is a growing threat to the health domain, across the world. The World Health Organization reports that 81% of the adolescents do not keep up to the daily recommendations of physical activity. In countries like India, a steady decline in the physical fitness has been seen, especially in the urban school children. This is because they spend an average of 8 to 9 hours weekly in additional tuitions or coaching classes. Their “play” time is being reduced and they are forced to “study” in those hours to keep up their academics in this competitive world.Considering physical inactivity to be a problem in today’s world and the growing evidences on physical fitness being related to cognition and academic performance, there is a need to explore more on these relationships. Thus, this study aims to find the correlation between physical fitness, academic performance and cognitive functions in adolescent urban school children.

HYPOTHESIS: There will be an association between physical fitness, academic performance and cognitive function.

CLINICAL IMPORTANCE: If an association is found between these three domains, it will help change one’s perspective about exams. Children will indulge more in physical activities. This will not only improve their physical health but also have an effect on the mental health.

FUTURE SCOPE: Further studies may include interventional programs in addition to the school physical training sessions to find the added benefits of a scheduled exercise program.

 
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