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CTRI Number  CTRI/2019/09/021341 [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 Muscle Length in Young Adults 
Scientific Title of Study   Relationship Between Body Mass Index and Flexibility in Young Adults 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ashwini Akash Gite 
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  8407906109  
Fax    
Email  ashwini.gite06@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Neha Mukkamala 
Designation  Assistant Professor 
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 
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  Ashwini Akash Gite 
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 young adults 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  Self declared healthy young adult subjects between the age of 18 to 30 years , of either
gender.  
 
ExclusionCriteria 
Details  Any history of pain, injury or surgery to the low back.
Musculoskeletal injury to the hip or knee that can hamper test performance will be
excluded from the study.
Neurological condition of any type will be excluded from the study.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Body Mass Index, Sit and Reach Test, Active Knee Extension Test  All Outcome measures will be taken Once in the duration of research study of 1 year. 
 
Secondary Outcome  
Outcome  TimePoints 
Global Physical Activity Questionnaire  All Outcome measures will be taken Once in the duration of research study of 1 year. 
 
Target Sample Size   Total Sample Size="1029"
Sample Size from India="1029" 
Final Enrollment numbers achieved (Total)= "570"
Final Enrollment numbers achieved (India)="570" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/09/2019 
Date of Study Completion (India) 16/01/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
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   NIL 
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 which aimed to find out the relationship between Body Mass Index(BMI) and flexibility in young adults in 579 subjects that 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 measure taken were Body Mass Index, Global Physical Activity Questionnaire, Sit and Reach Test, Active Knee Extension Test , which were taken at the time of enrollment of the participant. Mean BMI was 21.83±4.81 kg/m2. There was very weak negative correlation between BMI and Low Back and Hamstring Flexibility(r=-0.14), and weak positive correlation BMI and Hamstring Flexibility(Rt) (r=0.007), (Lt)(r=0.022), both of which were statistically not significant. Association between BMI and GPAQ was statistically significant (p=0.02). In this study males were more flexible and physically active compared to females. There was no statistically significant correlation found between BMI and flexibility. But BMI and physical activity levels showed a statistically significant association.


 
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