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
|
|
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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Healthy adolescents |
|
Intervention / Comparator Agent
|
|
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.
|