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CTRI Number  CTRI/2020/12/029709 [Registered on: 10/12/2020] Trial Registered Prospectively
Last Modified On: 24/10/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Agreement between maximal oxygen uptake (VO2max) estimated from two submaximal exercise tests (Six Minute Walk Test and Chester Step Test) in normal adults 
Scientific Title of Study   Agreement between VO2max estimated from Six Minute Walk Test and Chester Step Test in normal adults 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sushama Bhandare 
Designation  Assistant Professor 
Affiliation  PT School and Centre, Seth GS Medical College and KEM Hospital 
Address  PT School and Centre, Seth G S Medical College and KEM Hospital, Acharya Dhonde Marg, Parel East

Mumbai
MAHARASHTRA
400012
India 
Phone  02224143435  
Fax    
Email  sushamab7@rediffmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sushama Bhandare 
Designation  Assistant Professor 
Affiliation  PT School and Centre, Seth GS Medical College and KEM Hospital 
Address  PT School and Centre, Seth G S Medical College and KEM Hospital, Acharya Dhonde Marg, Parel East

Mumbai
MAHARASHTRA
400012
India 
Phone  02224143435  
Fax    
Email  sushamab7@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Sayali Rasal 
Designation  Post graduate student (MPT) 
Affiliation  PT School and Centre, Seth GS Medical College and KEM Hospital 
Address  PT School and Centre, Seth G S Medical College and KEM Hospital, Acharya Dhonde Marg, Parel East

Mumbai
MAHARASHTRA
400012
India 
Phone  02224143435  
Fax    
Email  rasalsayali137@gmail.com  
 
Source of Monetary or Material Support  
PT School and Centre, Seth G S Medical College and KEM Hospital, Acharya Dhonde Marg, Parel East, Mumbai 400012 
 
Primary Sponsor  
Name  Sushama Bhandare 
Address  PT School and Centre, Seth G S Medical College and KEM Hospital, Acharya Dhonde Marg, Parel East, Mumbai 400012 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Sushama Bhandare  PT School and Centre, Seth GS Medical College and KEM Hospital  PT School and Centre, Seth G S Medical College and KEM Hospital, Acharya Dhonde Marg, Parel East
Mumbai
MAHARASHTRA 
02224143435

sushamab7@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC)-II, Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra, India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  None  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1. Normal healthy adults
2. Able to complete Stage 3 of Chester Step Test 
 
ExclusionCriteria 
Details  1. Subjects engaged in regular sports or vigorous physical activity
2. Obese individuals (BMI > 23 kg/m2) (Indian population) 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
VO2max estimated from
1. Six Minute Walk Test by equation given by Burr et al.
2. Chester Step Test Graph by plotting heart rate points vs incremental workload in stages  
Estimation of VO2max to be done immediate to the completion of each exercise test. 
 
Secondary Outcome  
Outcome  TimePoints 
None  NA 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/01/2021 
Date of Study Completion (India) 30/07/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
World Journal of Advanced Research and Reviews, 2022, 15(01), 018-030 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Cardiorespiratory fitness denotes the capacity of an individual to perform large muscle, dynamic, moderate to vigorous physical activity for a prolonged period of time. It depends upon the integrated functional status of the cardiovascular, respiratory, metabolic and musculoskeletal systems. The assessment of cardiorespiratory fitness is of pivotal importance as it gives us a general idea of the fitness of the individual and is a vital part of any preventive or rehabilitation program. The criterion used to assess the cardiorespiratory fitness is maximal oxygen uptake (VO2max) expressed in liters/minute (L/min) as an absolute value or in milliliters/kilogram/minute (ml/kg/min) as relative VO2max. It is the maximal rate at which one can consume oxygen during physical activity and the true physiological limit reached where no further increase in the oxygen uptake will occur on continuing the exercise. The gold standard for measuring VO2max is graded maximal exercise testing, performed in a lab using gas analysis. Maximal exercise testing protocols mandate the requirement of an expensive laboratory setup of equipments, monitoring systems and emergency equipments, require trained personnel, are time consuming and labor intensive and risk the precipitation of unwarranted symptoms which may lead to adverse events. When compared to maximal exercise testing, submaximal exercise tests have a greater applicability to physiotherapists in assessment of cardiorespiratory fitness and exercise prescription due to their low-risk, low-cost, low-supervision nature and objective evaluation of VO2max.

The six minute walk test is a commonly used self paced, level ground walking submaximal exercise test performed across a 100 feet hallway for six minutes. The 6MWT results and the anthropometric variables of the individual are used to estimate the VO2max using the equation given by Burr et al. The Chester Step Test is a submaximal incremental metronome based multistage step test. The total test time is of 10 minutes comprising five stages lasting for 2 minutes each.  The step height is adaptable depending upon the age and the physical abilities of the individual. The VO2max is estimated by plotting a graph of the heart rate points achieved at the end of each stage on the specified Chester step test data record sheet. Thus the current study was undertaken to assess the agreement between the VO2max estimated by these two submaximal exercise tests namely the six minute walk test and Chester step test.

80 normal healthy adults (40 males and 40 females) between the age group of 18-40 years and able to complete Stage 3 of Chester step test were recruited for this study. Individuals engaged in regular sports or vigorous physical activity and those with BMI greater than 23 kg/m2 were excluded. The participants were explained about the study protocol, the purpose of the study and written consent was obtained from them. The six minute walk test was performed on the first day followed by the Chester Step Test on the next day for all odd numbered participants and vice versa for even numbered participants. A practice test and then the final test were performed on the same day with a gap of minimum 1 hour between the two tests. 

The mean VO2max-6MWT and VO2max-CST were 43.53 ± 4.65 ml/kg/min and 38.34 ± 4.94 ml/kg/min respectively. The Bland and Altman analysis revealed that the mean difference between VO2max-6MWT and VO2max-CST was 5.19 ± 5.50 ml/kg/min which exceeded the maximum acceptable difference of 3 ml/kg/min decided a priori. The standard error of mean was 0.61 ml/kg/min and the standard error of limits of agreement was 1.06 ml/kg/min. It was therefore concluded that an agreement did not exist between VO2max-6MWT and VO2max-CST in the given study population and that the tests cannot be used interchangeably.

 

 


 
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