| 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
|
|
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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
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
None |
|
|
Intervention / Comparator Agent
|
|
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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. |