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
|
|
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
|
|
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 populations. Understanding 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. |