| CTRI Number |
CTRI/2026/03/105867 [Registered on: 10/03/2026] Trial Registered Prospectively |
| Last Modified On: |
23/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A STUDY TO COMPARE 1 MINUTE SIT TO STAND TEST AGAINST SIX MINUTE WALK TEST TO MONITOR PATIENTS OF CHRONIC LUNG DISEASE. |
|
Scientific Title of Study
|
A STUDY TO COMPARE 1 MINUTE SIT TO STAND TEST WITH SIX MINUTE WALK TEST AS AN INDICATOR OF EXERCISE IMPAIRMENT 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 |
ZAIN FATEH |
| Designation |
SENIOR RESIDENT |
| Affiliation |
MAULANA AZAD MEDICAL COLLEGE AND LOK NAYAK HOSPITAL |
| Address |
DEPARTMENT OF PULMONARY MEDICINE,NEW MEDICAL BLOCK, LOK NAYAK HOSPITAL ,DELHI
2 BAHADUR SHAH ZAFAR ROAD,NEAR DELHI GATE,DELHI-11002
Central
DELHI
110002
India |
| Phone |
7679460178 |
| Fax |
|
| Email |
zainmd.2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
NARESH KUMAR |
| Designation |
DIRECTOR PROFESSOR AND HEAD OF DEPARTMENT |
| Affiliation |
MAULANA AZAD MEDICAL COLLEGE AND LOK NAYAK HOSPITAL. |
| Address |
DEPARTMENT OF PULMONARY MEDICINE, NEW MEDICAL BLOCK, LOK NAYAK HOSPITAL , DELHI
2 BAHADUR SHAH ZAFAR ROAD,NEAR DELHI GATE,DELHI-11002
Central
DELHI
110002
India |
| Phone |
9953946064 |
| Fax |
|
| Email |
drnareshmamc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ZAIN FATEH |
| Designation |
SENIOR RESIDENT |
| Affiliation |
Lok Nayak Hospital & MAMC Delhi |
| Address |
DEPARTMENT OF PULMONARY MEDICINE, NEW MEDICAL BLOCK,LOK NAYAK HOSPITAL DELHI.
Central
DELHI
110002
India |
| Phone |
7679460178 |
| Fax |
|
| Email |
zainmd.2@gmail.com |
|
|
Source of Monetary or Material Support
|
| MAULANA AZAD MEDICAL COLLEGE AND LOK NAYAK HOSPITAL 2,BAHADUR SHAH ZAFAR MARG NEAR DELHI GATE,DELHI-110002.
CENTRAL DELHI, INDIA |
|
|
Primary Sponsor
|
| Name |
MAULANA AZAD MEDICAL COLLEGE AND LOK NAYAK HOSPITAL |
| Address |
MAULANA AZAD MEDICAL COLLEGE AND LOK NAYAK HOSPITAL 2,BAHADUR SHAH ZAFAR MARG NEAR DELHI GATE,DELHI-110002. CENTRAL DELHI, INDIA |
| 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 |
| Zain Fateh |
LOK NAYAK HOSPITAL DELHI |
DEPARTMENT OF PULMONARY MEDICINE, ROOM NO-10, NEW MEDICAL BLOCK
2,BAHADUR SHAH ZAFAR MARG NEAR DELHI GATE,DELHI-110002. CENTRAL DELHI, INDIA
Central
DELHI |
7679460178
zainmd.2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana_Azad_Medical_College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J849||Interstitial pulmonary disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Newly diagnosed or previously diagnosed case of interstitial lung disease based on clinico-radiological criteria.
Patients providing written informed consent. |
|
| ExclusionCriteria |
| Details |
Patients unable to perform procedure.
Contraindications to spirometery
Hemodynamically unstable patients
Severe hypoxemia
Significant musculoskeletal/neurological deficit |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of nadir Spo2,heart rate,borg scale value obtained from one minute sit to stand test with similar parameters obtained from six minute walk test. |
At One year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Conparison of nadir Spo2, heart rate and borg scale value obtained from one minute sit to stand test and six minute walk test with Forced vital capacity, Total lung capacity and Diffusion Lung capacity for Carbon Monoxide(DLCO) values.
2.Association of High Resolution Computed Tomography(HRCT) findings with Diffusion lung capacity for carbon monoxide(DLCO) values in patients of Interstitual Lung disease.
3.Comparison of nadir Spo2, heart rate and borg scale value obtained from one minute sit to stand test and six minute walk test in different subtypes of Interstitial Lung Disease. |
One year |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
15/03/2026 |
| 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 Six Minute Walk Test (6MWT) is the gold standard for assessing Interstitial Lung Disease (ILD) but is time consuming and requires significant physical space (a 30 meter corridor). The Objective To evaluate if the 1-Minute Sit-to-Stand Test (1-MSTST)—a rapid, space saving alternative, is a valid indicator of exercise impairment and desaturation compared to the 6MWT. Methodology Design-A prospective, comparative study of ILD patients. Procedure-Participants perform both tests; the number of 1-MSTST repetitions will be correlated with the 6MWT distance. Parameters-Heart rate, SpO2 desaturation, and perceived exertion (Borg Scale) will be monitored for both. Outcome To demonstrate that the 1-MSTST is a reliable, clinical tool for monitoring ILD progression, especially in resource-limited or crowded settings. |