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CTRI Number  CTRI/2024/07/070808 [Registered on: 18/07/2024] Trial Registered Prospectively
Last Modified On: 17/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Investigating How Strong Your Core Affects How Long You Can Hold Your Breath in Young Adults 
Scientific Title of Study   Correlation of Core Endurance with Breath Hold Time in normal young adults 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sushama Bhandare 
Designation  Assistant Professor 
Affiliation  Seth GSMC and KEMH 
Address  Physiotherapy school and centre Seth Gordhandas Sunderdas Medical college and KEM Hospital OC building OPD room no. 402 Parel Mumbai 400012

Mumbai
MAHARASHTRA
400012
India 
Phone  9763576098  
Fax    
Email  sushamab7@rediffmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sushama Bhandare 
Designation  Assistant Professor 
Affiliation  Seth GSMC and KEMH 
Address  Physiotherapy school and centre Seth Gordhandas Sunderdas Medical college and KEM Hospital OC building OPD room no. 402 Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9763576098  
Fax    
Email  sushamab7@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sushama Bhandare 
Designation  Assistant Professor 
Affiliation  Seth GSMC and KEMH 
Address  Physiotherapy school and centre Seth Gordhandas Sunderdas Medical college and KEM Hospital OC building OPD room no. 402 Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9763576098  
Fax    
Email  sushamab7@rediffmail.com  
 
Source of Monetary or Material Support  
Physiotherapy school and centre Seth Gordhandas Sunderdas medical college, Parel Mumbai 400012 
 
Primary Sponsor  
Name  Dr Sushama Bhandare  
Address  Physiotherapy school and centre Seth Gordhandas Sunderdas Medical college and KEM Hospital OC building room no. 402 Parel Mumbai 400012 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
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 Khushbu Lichade PT  Physiotherapy school and centre Seth Gordhandas Sunderdas Medical College and KEM hospital   Physiotherapy school and centre Seth Gordhandas Sunderdas Medical college and KEM Hospital OC building OPD room no. 402, Acharya dhonde marg, Parel Mumbai 400012
Mumbai
MAHARASHTRA 		 9763576098

khushbu1431999@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE -3 OF SETH GS MEDICAL COLLEGE MUMBAI  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Normal Young Adults 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  1. Age group: 18-25 years
2. BMI is 18.5 - 23.0 kg/m2
3. Willing to participate
4. Individuals who are able to perform McGill protocol
 
 
ExclusionCriteria 
Details  1. Recent back surgery, and/or are in the midst of an acute low-back flare-up
2. With major strength deficiencies, where the individual cannot even lift the torso from a forward flexed position to a neutral position
3. MSK, CVRS and Neuro conditions
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Mcgill’s torso muscular endurance test battery
2. Breath Hold Time 		 1 time assessment at 0 week 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
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)   01/08/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/08/2024 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Core is the group of trunk muscles that surround the spine and abdominal viscera. Core endurance is defined as the ability to maintain a position or perform multiple repetitions. Breath hold time is measure of cardiopulmonary reserve measured by the length of time that a person can hold breath voluntarily. Breath hold time needs static contraction of diaphragm, there is evidence which shows that there’s linear correlation between breath holding time and core strength which also poses further to find out if any correlation exists between breath hold time and core endurance. Study aims to find out correlation of core endurance with breath hold time in normal young adults. A correlation study will be conducted, with sample size 62. Core endurance will be measured using McGill protocol; first flexor group, then side flexors and lastly extensor group will be assessed according to the protocol with a break of 10 minutes between each test of muscles. After recording the core endurance 10 min break will be given followed by which breath hold time will be recorded in which 3 trials will be taken and the best reading will be noted. Cross overs will be maintained to avoid any biases in the results. 
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