| CTRI Number |
CTRI/2025/07/091388 [Registered on: 22/07/2025] Trial Registered Prospectively |
| Last Modified On: |
24/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study on the effect of Gender and Level of Physical Activity on Sit-to-Stand tests performance in patients with Interstitial Lung Disease |
|
Scientific Title of Study
|
Effect of Gender and Level of Physical Activity on Sit-to-Stand test performance in patients with Interstitial Lung Disease |
| Trial Acronym |
STST, ILD |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jatin |
| Designation |
PG Student |
| Affiliation |
College of Physiotherapy, Pt. B.D. Sharma PGIMS, Rohtak |
| Address |
Pt. Bhagwat Dayal Sharma PGIMS, Rohtak, Haryana, India
Rohtak
HARYANA
124001
India |
| Phone |
7404457012 |
| Fax |
|
| Email |
jatinbhutani61@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gitanjali Sikka |
| Designation |
Associate Professor |
| Affiliation |
College of Physiotherapy, Pt. B.D. Sharma PGIMS, Rohtak |
| Address |
Pt. Bhagwat Dayal Sharma PGIMS Rohtak, Haryana, India
Rohtak
HARYANA
124001
India |
| Phone |
7027192620 |
| Fax |
|
| Email |
gsikka27@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jatin |
| Designation |
PG Student |
| Affiliation |
College of Physiotherapy, Pt. B.D. Sharma PGIMS, Rohtak |
| Address |
Pt. Bhagwat Dayal Sharma PGIMS, Rohtak, Haryana, India
Rohtak
HARYANA
124001
India |
| Phone |
7404457012 |
| Fax |
|
| Email |
jatinbhutani61@gmail.com |
|
|
Source of Monetary or Material Support
|
| College of Physiotherapy, Pt. B. D. Sharma PGIMS, Rohtak, Haryana, India, 124001 |
|
|
Primary Sponsor
|
| Name |
College of Physiotherapy, PGIMS, Rohtak |
| Address |
Pt. B.D. Sharma University of Health Sciences, Rohtak, Haryana, India, 124001 |
| 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 |
| Dr Jatin |
Pt. B.D. Sharma PGIMS, Rohtak, Haryana, India |
Outpatient Department, Pulmonary Critical Care and Medicine, Rohtak, Haryana, India, 124001
Rohtak
HARYANA |
7404457012
jatinbhutani61@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee |
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 |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
All genders, clinically diagnosed with Interstitial Lung Disease.
Ability to perform Sit-to-Stand test unaided. |
|
| ExclusionCriteria |
| Details |
Patients with co-morbidities like COPD and lung cancer.
Recent acute exacerbation.
Unstable cardiac disease.
Long-term oxygen therapy. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
1. Sit-to-Stand Test Performance
a. 5-repetition STST: Time taken to complete 5 repetitions.
b. 10-second STST: Number of repetitions in 10s.
c. 30-second STST: Number of repetitions in 30s.
d. 60-second STST: Number of repetitions in 60s.
2. Physical Activity Assessment
a. International Physical Activity Questionnaire (IPAQ)
b. Paffenbarger Physical Activity and Exercise Index |
At Baseline |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
1. Cardiorespiratory Parameters (Heart Rate, Oxygen Saturation, Blood Pressure)
2. Fatigue (Borg CR10 Scale)
3. Pulmonary Function testing (Spirometry) [FEV1, FVC, FEV1/FVC ratio] |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/08/2025 |
| 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="1"
Months="1"
Days="1" |
|
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
|
This study will investigate the differences in the various Sit-to-Stand test performances among male and female ILD patients across different physical activity levels. A total of 60 participants will be assessed using validated sit-to-stand test protocols, with functional capacity, physical activity, cardiorespiratory response, fatigue and pulmonary function tests measured. The aim is to clarify the impact of gender and level of physical activity on performance, contributing to better management and rehabilitation planning for ILD patients. |