| CTRI Number |
CTRI/2024/07/069809 [Registered on: 02/07/2024] Trial Registered Prospectively |
| Last Modified On: |
01/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Agreement between maximal uptake of oxygen calculated by walking for six minutes and performing step test in healthy adults who do not exercise daily |
|
Scientific Title of Study
|
Agreement between VO2 max estimated from six minute walk test and Siconolfi step test in healthy untrained 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 |
Sushama Bhandare |
| Designation |
Assistant Professor |
| Affiliation |
Seth G S Medical College and KEMH |
| Address |
Seth G S Medical College and
KEMH
Physiotherapy School and centre
OPD 402
Cardiovascular and respiratory department
Opp Tata Hospital Parel Mumbai 12
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9820219984 |
| Fax |
|
| Email |
sushamab7@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sushama Bhandare |
| Designation |
Assistant Professor |
| Affiliation |
Seth G S Medical College and KEMH |
| Address |
Seth G S Medical College and
KEMH
Physiotherapy School and centre
OPD 402
Cardiovascular and respiratory department
Opp Tata Hospital Parel Mumbai 12
MAHARASHTRA
400012
India |
| Phone |
9820219984 |
| Fax |
|
| Email |
sushamab7@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Saloni Patil |
| Designation |
PG student |
| Affiliation |
Seth G S Medical College and KEMH |
| Address |
Seth G S Medical College and
KEMH
Physiotherapy School and centre
OPD 402
Cardiovascular and respiratory department
Opp Tata Hospital Parel Mumbai 12
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9527790192 |
| Fax |
|
| Email |
patilsaloni478@gmail.com |
|
|
Source of Monetary or Material Support
|
| Seth GS Medical College and KEM Hospital Parel Dr E Borges Road Mumbai 12
Pin 400012
Maharashtra,
India
|
|
|
Primary Sponsor
|
| Name |
Physiotherapy School and centre Seth GS Medical College and KEMH |
| Address |
Physiotherapy School and centre and Department of cardiology
Seth GS Medical College and KEM Hospital Parel east Mumbai 12 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Sushama Bhandare |
Physiotherapy School and Centre Seth GS Medical College |
Physiotherapy School and
Centre Department of
Cardiopulmonary
Rehabilitation Seth G S
Medical College and
KEMH Parel Mumbai
12
Mumbai
MAHARASHTRA
Mumbai
MAHARASHTRA |
9820219984
sushamab7@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Seth GS Medical Institutional Ethics committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy untrained individuals with age 18 – 29 years |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
29.00 Year(s) |
| Gender |
Both |
| Details |
1)Both genders
2) Age 18 – 29 years
3)healthy untrained individuals
|
|
| ExclusionCriteria |
| Details |
1)Young Adults With Any Neuromuscular, Cardiorespiratory, and vascular condition
2)Young adults involved in any sports specific training
3)Individuals performing aerobic exercises on daily basis
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Six minute walk test
Siconolfi step test |
This is one time study hence boththe outcomes will be taken only once with the resting period of 1 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="67"
Sample Size from India="67"
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) |
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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
VO2 max is a widely accepted measure of fitness which indicates maximum rate of oxygen transport to exercising muscle. It is expressed in liters of O2 consumed per minute. Siconolfi step test and six minute walk test can be used to predict VO2 max. Purpose of this study is to assess whether an agreement exists between the VO2 max estimated by six minute walk test and Siconolfi step test, which can allow expanding this study in various population and help to assess feasibility and applicability of siconolfi step test to replace the six minute walk test. Study aims to assess agreement between VO2 max estimated from six minute walk test and siconolfi step test in healthy untrained young adults.First weight and height of the subject will be taken. Vitals will be taken (Heart rate, respiratory rate, RPE, spo2) then the subject will perform a six minute walk test, and siconolfi step test with a washout period of one hour. Post test vitals will be taken after each test. Data analysis will be done using obtained results. Cross overs will be maintained to avoid any biases in the results.
|