| CTRI Number |
CTRI/2025/08/092768 [Registered on: 11/08/2025] Trial Registered Prospectively |
| Last Modified On: |
09/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the co relation between 1 minute sit to stand test and 6 minute walk test in Interstitial Lung Disease. |
|
Scientific Title of Study
|
To Study the co relation between 1 minute sit to stand test and 6 minute walk test in patients of Interstitial Lung Disease. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Subhajit Khamaru |
| Designation |
DM Fellow |
| Affiliation |
AIIMS,Rajkot |
| Address |
Department of Pulmonary Medicine
AIIMS, Rajkot
Rajkot
GUJARAT
360110
India |
| Phone |
08961374093 |
| Fax |
|
| Email |
subhajit.mck@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kunal Deokar |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS,Rajkot |
| Address |
Department of Pulmonary Medicine, AIIMS, Rajkot
Rajkot
GUJARAT
360110
India |
| Phone |
08169451380 |
| Fax |
|
| Email |
dkunal@live.in |
|
Details of Contact Person
Public Query
|
| Name |
Subhajit Khamaru |
| Designation |
DM Fellow |
| Affiliation |
AIIMS,Rajkot |
| Address |
Department of Pulmonary Medicine,
AIIMS,RAJKOT
Department of Pulmonary Medicine, AIIMS, Rajkot
Rajkot
GUJARAT
360110
India |
| Phone |
08961374093 |
| Fax |
|
| Email |
subhajit.mck@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Subhajit Khamaru |
| Address |
ROOM NO 520
AIIMS MAIN BOYS HOSTEL
AIIMS,RAJKOT
RAJKOT,GUJARAT
PIN-360110 |
| 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 |
| Subhajit Khamaru |
AIIMS RAJKOT |
Pulmonary Medicine
Rajkot
GUJARAT |
08961374093
subhajit.mck@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| InstitutionalEthicsCommittee,AIIMS,Rajkot |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J848||Other specified interstitial pulmonary diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
PATIENTS OF INTERSTITIAL LUNG DISEASE |
|
| ExclusionCriteria |
| Details |
1]NOT GIVING CONSENT
2]POOR COMPREHENSION CAPACITY
3]HYPOXIC AT ROOM AIR,SPO2 LESS THAN 88%
4]HEMODYNAMICALLY UNSTABLE
5]UNABLE TO PERFORM THE TESTS
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| There is good correlation between 1 minute sit to stand test and 6-minute walk test in patients of Interstitial Lung Disease. |
At the 1st visit to the Pulmonary medicine OPD after diagnosis of Interstitial Lung Disease |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="69"
Sample Size from India="69"
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)
|
20/08/2025 |
| 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="0"
Months="8"
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
|
Interstitial Lung Disease is a chronic lung disease of interstitial lung inflammation and fibrosis. Due to varied etiology ILD often has diverse presentations and an unpredictable course. Hence monitoring the disease to assess treatment response is a vital part of the disease management. Exercise testing has emerged as a promising method of disease evaluation that can also be useful in early part of the disease. Out of different exercise tests 6 minute walk test is easy to perform and reproducible. However it is time consuming requires 30 meter long corridor which is not available in many health centers. This test is sensitive to change in methodology such as supplemental oxygen, track layout and its length and to the variations of verbal instructions. 1 minute sit to stand test has been evaluated in different respiratory conditions, its less time consuming and requires only a standard chair, on which patient is supposed to perform repeated sit down and stand up maneuvers for a duration of 1 minute. The present study is conducted to co relate 6 minute walk test and 1 minute sit to stand test in patients of ILD. |