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CTRI Number  CTRI/2025/04/084482 [Registered on: 09/04/2025] Trial Registered Prospectively
Last Modified On: 08/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Assessing the Validity and Reliability of the 2-Minute Step Test in Children with Normal, Overweight, and Obese BMI 
Scientific Title of Study   Validity and Reliability of 2-Minute Step Test in Normal, Overweight and Obese children. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aradhana Chhabra 
Designation  PG student  
Affiliation  M.M Institute of Physiotherapy and Rehabilitation 
Address  Room No. 6, Ground Floor, Department of Physiotherapy, M.M Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar Mullana

Ambala
HARYANA
133203
India 
Phone  09816870145  
Fax    
Email  aradhanachhabra19@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kanu goyal 
Designation  Assistant professor  
Affiliation  M.M Institute of Physiotherapy and Rehabilitation 
Address  Room No. 6, Ground Floor, Department of Physiotherapy, M.M Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar Mullana

Ambala
HARYANA
133203
India 
Phone  7015143108  
Fax    
Email  goyalkanu02@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Kanu goyal 
Designation  Assistant professor  
Affiliation  M.M Institute of Physiotherapy and Rehabilitation 
Address  Room No. 6, Ground Floor, Department of Physiotherapy, M.M Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar Mullana

Ambala
HARYANA
133203
India 
Phone  7015143108  
Fax    
Email  goyalkanu02@gmail.com  
 
Source of Monetary or Material Support  
Aradhana Chhabra Room No. 6, Ground Floor, Department of Physiotherapy, M.M Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar Mullana  
 
Primary Sponsor  
Name  Aradhana Chhabra 
Address  Room No. 6, Ground Floor, Department of Physiotherapy, M.M Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar Mullana  
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 
Aradhana Chhabra  MM international school, Mullana   Room no: 112 block B ground floor MM international school, mullana
Ambala
HARYANA 
09816870145

aradhanachhabra19@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, Maharishi Markandeshwar Institute Of Medical Sciences And Reserch Mullana, Ambala, Communication of Decision of the Ethics Committee (IEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Normal, Overweight And Obese children. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1.BMI for 5 to 19 years old children
Normal:5th percentile to less than the 85th percentile
Overweight:85th to less than the 95th percentile.22 2.Able to follow verbal commands
 
 
ExclusionCriteria 
Details  1. Orthopaedics or neurological impairment
2. Myocardial infarction; implanted pacemaker or any metallic prosthesis; unstable angina; chronic heart rhythm disorders
3. Moderate or severe heart valvular disease; uncontrolled hyper tension; uncontrolled and/or insulin-dependent diabetes mellitus
4. Any history of respiratory disease
 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
2 Min step test  two time at Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
spO2
Heart Rate (HR)
 
Two time at Baseline

 
 
Target Sample Size   Total Sample Size="360"
Sample Size from India="360" 
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)   26/04/2025 
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 Yet Recruiting 
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  

The assessment of physical fitness in children is crucial for promoting health and preventing obesity-related issues. One of the popular methods for evaluating cardiovascular endurance is the 2min step test, which measures how effectively a child can perform a stepping exercise over a defined duration. The 2 Minute Step Test (2MST) is a simple, cost-effective measure of cardiovascular endurance, often utilized in pediatric populationsUnderstanding the Reliability and validity of this test is particularly important when considering variations in body composition among children, as differences in fat mass and lean body mass can influence performance outcomes and health implication. To assess the Validity and Reliability of the 2MST in children with varying body compositions, including those classified as normal weight, overweight, and obese. A sample of 360 children aged 6 to 12 years will be recruited and characterized based on their Body Mass Index (BMI). Each participant will undergo the 2MST twice, with performance measured in the number of steps completed in two minutes. Subjects will be recruited based on inclusion criteria. The 2 Min Step test will be conducted, we will count the maximum number of knee elevations that the individual can perform in 2 minutes, in which the minimum height occurs at a midpoint of the distance between the patella and the anterior superior iliac spine (during a stationary gait, without displacing the body). The data will be analyzed by using SPSS software (Statistical Package for Social Sciences version 20.0). To check the normality, Kolmogorov test will be applied as sample size estimated is 360.

 
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