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CTRI Number  CTRI/2019/09/021339 [Registered on: 19/09/2019] Trial Registered Prospectively
Last Modified On: 08/06/2020
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Relationship between Index for Body Mass and Physical Fitness in College Students  
Scientific Title of Study   Relationship between BMI and Physical Fitness in College Students  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shaily Bharat Parekh 
Designation  Post Graduate Student 
Affiliation  Sumandeep Vidyapeeth an Institution Deemed to be University 
Address  PG Classroom, On Ground Floor, College of Physiotherapy,Sumandeep Vidyapeeth an Institution Deemed to be University, At and Post Piparia, Taluka Waghodia, District Vadodara

Vadodara
GUJARAT
391760
India 
Phone  7276878448  
Fax    
Email  shailyparekh2612@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Neha Mukkamala 
Designation  Assistant Professor and Guide 
Affiliation  Sumandeep Vidyapeeth an Institution Deemed to be University 
Address  Staff Room, On Ground Floor, College of Physiotherapy,Sumandeep Vidyapeeth an Institution Deemed to be University, At and Post Piparia, Taluka Waghodia, District Vadodara

Vadodara
GUJARAT
391760
India 
Phone  9898216184  
Fax    
Email  neha.cop@sumandeepvidyapeethdu.edu.in  
 
Details of Contact Person
Public Query  
Name  Neha Mukkamala 
Designation  Assistant Professor and Guide 
Affiliation  Sumandeep Vidyapeeth an Institution Deemed to be University 
Address  Staff Room, On Ground Floor, College of Physiotherapy,Sumandeep Vidyapeeth an Institution Deemed to be University, At and Post Piparia, Taluka Waghodia, District Vadodara

Vadodara
GUJARAT
391760
India 
Phone  9898216184  
Fax    
Email  neha.cop@sumandeepvidyapeethdu.edu.in  
 
Source of Monetary or Material Support  
College of Physiotherapy, Sumandeep Nursing College, K.M Shah Dental College and Hospital, Smt.B.K. Shah Medical Institute and research Centre,Department of Pharmacy, Department of Management all affiliated to Sumandeep Vidyapeeth an institution Deemed to be University.  
 
Primary Sponsor  
Name  Shaily Bharat Parekh 
Address  College of Physiotherapy,Sumandeep Vidyapeeth an Institution Deemed to be University, At and Post Piparia, Taluka Waghodia, District Vadodara 
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 
Neha Mukkamala  Sumandeep Vidyapeeth an Institution Deemed to be University and its constituent colleges  Neuro Physiotherapy Lab, Pediatric Physiotherapy Lab, On Ground floor, College Of Physiotherapy, At and Post Piparia, Taluka Waghodia, District Vadodara
Vadodara
GUJARAT 		 9898216184

neha.cop@sumandeepvidyapeethdu.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sumandeep Vidyapeeth Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  healthy college going students 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  Males and Female between 18 to 30 years of age in the study in college students.

 
 
ExclusionCriteria 
Details  Any history of pain in upper limb and lower limb which can affect the performance of the test.

Subjects with any neuro-musculoskeletal system pathology which can affect the performance of the test.

Subjects with cardiac-respiratory conditions which can affect the performance of the test.

Elite athletes (individuals training/competing at a high level).
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Body Mass Index, Sit Up Test, Push Up Test and Queens College Step Test  All Outcome measures will be taken Once in the duration of research study of 1 year. 
 
Secondary Outcome  
Outcome  TimePoints 
Body Mass Index, Sit Up Test, Push Up Test and Queens College Step Test  All Outcome measures will be taken Once in the duration of research study of 1 year. 
 
Target Sample Size   Total Sample Size="79"
Sample Size from India="79" 
Final Enrollment numbers achieved (Total)= "180"
Final Enrollment numbers achieved (India)="180" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/09/2019 
Date of Study Completion (India) 31/12/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 31/12/2019 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Yet to publish. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  		  A cross sectional study was conducted, aim of the study was to find out the relationship between Body Mass Index(BMI) and Physical Fitness in College Students in 180 subjects which was conducted in College of Physiotherapy, Sumandeep Nursing College, K.M Shah Dental College and Hospital, Smt. B.K. Shah Medical Institute and Research Centre, Department of Pharmacy, Department of Management all affiliated to Sumandeep Vidyapeeth an Institution Deemed to be University,  Vadodara in India. The outcome measures were Body Mass Index, Sit Up Test, Push Up Test and Queen’s College Step Test. The study resulted that Males had performed significantly better than females in all the test. In both the genders, decreasing performance was observed from normal weight to underweight to overweight to obese. The association between BMI and physical fitness test were not statistically significant. The correlation between BMI and physical fitness test shows weak positive correlation. The study concluded that Performances on fitness tests varied with weight status. Higher BMI were generally associated with Lower physical fitness. The relationship between BMI and physical fitness in college students were non-linear. 
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