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CTRI Number  CTRI/2025/09/094733 [Registered on: 15/09/2025] Trial Registered Prospectively
Last Modified On: 12/09/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Checking How Silicosis Affects Breathing by Measuring How Far Patients Can Walk 
Scientific Title of Study   Assessment Of Exercise Capacity In Silicosis Patients Using Desaturation Distance Ratio From Six Minute Walk Test 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Payal Kumawat 
Designation  2nd Year MBBS Student 
Affiliation  RUHS college of Medical Science, jaipur 
Address  Rajasthan University Of Health Sciences Kumbha Marg Pratap Nagar Jaipur

Jaipur
RAJASTHAN
302033
India 
Phone  9326385909  
Fax    
Email  kumawatpayal9869@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sonali Sharma 
Designation  Professor 
Affiliation  RUHS college of Medical Science, jaipur 
Address  2nd Floor Dept Of Biochemistry RUHS CMS Kumbha Marg Pratap Nagar Jaipur

Jaipur
RAJASTHAN
302033
India 
Phone  9414314678  
Fax    
Email  sonalisharma14@gmail.com  
 
Details of Contact Person
Public Query  
Name  Payal Kumawat 
Designation  2nd Year MBBS Student 
Affiliation  RUHS college of Medical Science, jaipur 
Address  Rajasthan University Of Health Sciences Kumbha Marg Pratap Nagar Jaipur

Jaipur
RAJASTHAN
302033
India 
Phone  9326385909  
Fax    
Email  kumawatpayal9869@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Payal Kumawat  RUHS College of Medical Science   Academic Block, 1st floor , RUHS CMS , Sector 11 Kumbha Marg Pratap Nagar , Jaipur 302033
Jaipur
RAJASTHAN 		 9326385909

kumawatpayal9869@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
RUHSCMSETHICSCOMMITTEE   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J668||Airway disease due to other specific organic dusts,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  a. Patients should of be greater than18 years age
b. Confirmed diagnosis of silicosis based on spirometry and radiological findings.
c. Patients having history of occupational history of mining, construction and building, stone work, pottery, ceramics and glass making, sandblasting, foundry work or any other occupational history.  
 
ExclusionCriteria 
Details  a. Patients with history of an either unstable angina or
myocardial infarction) within 30 days prior to the test
b. Inability to perform 6 Minute Walk Test
c. Patients who are at risk of acute respiratory failure, or the presence of a noncardiopulmonary condition that may become exacerbated by exercise.
d. Patients with severe uncontrolled hypertension and a resting heart rate greater than 120 beats per minute
e. Any comorbidity which might affect exercise capacity.
f. Patients with any kind of neuromuscular
problems.
g. Patients on oxygen therapy.
h. Patients with acute T.B and lung tumors.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To measure the Desaturation Distance ratio (DDR) during 6 Minute Walk Test in patients with silicosis
2. To evaluate the corelation between DDR and severity of silicosis as determined by
spirometry and radiological findings 		 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
1. To investigate the relationship between DDR & Dyspnoea scores
2. To assess work fatigue in silicosis patients using Multidimensional Fatigue
Inventory (MFI-20) scale & to corelate with DDR 		 3 months 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   06/10/2025 
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="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

Silicosis, one of the most common occupational respiratory diseases, is an irreversible chronic lung disease caused by inhalation of silica dust in a crystalline form.The prevalence of silicosis in India ranges widely from 3.5% in the ordnance factory to 54.6% in the slate-pencil industry. Silicosis leads to decreased lung function capacity.

The 6-minute walk test (6MWT) is a test used for checking the exercise capacity of the patients by measuring the distance walked in 6 minutes. It is easy and inexpensive to perform, and reflects the functional capacity of patients. Many studies have proved its usefulness in as a prognostic indicator for predicting mortality or lung transplantation.

To monitor the progress of severity in patients with silicosis, evaluating capacity for work is important, by measuring the respiratory functions.

It is a hospital based cross sectional observational study, in which the Diagnosed Silicosis patients above 18 years of age attending the outpatient clinic of the Respiratory Medicine Department will be recruited. Their lung function tests will be done. 6-minute walk test(6MWT) will be performed along a 30-meter corridor, and their heart rate, blood pressure and oxygen saturation will be measured during before and after the test.

This study will help in Understanding the exercise capacity of silicosis patients, and then help in developing personalized rehabilitation programs that address their specific needs and limitations

 
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