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CTRI Number  CTRI/2024/10/074567 [Registered on: 01/10/2024] Trial Registered Prospectively
Last Modified On: 03/10/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   To study balance in people with lung disease and compare it to healthy individuals 
Scientific Title of Study   Comparison of balance in patients with Interstitial Lung Disease versus age matched normals Observational analytical study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mariya Jiandani 
Designation  Professor (Additional) 
Affiliation  Physiotherapy School and Centre Seth G S Medical College and KEMH 
Address  Room No 16, Ground Floor, CVTC Building, Physiotherapy School and Centre Seth G S Medical College and KEMH, Parel East, Mumbai, Maharashtra- 400012

Mumbai
MAHARASHTRA
400012
India 
Phone  9820191106  
Fax    
Email  mpjiandani@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mariya Jiandani 
Designation  Professor (Additional) 
Affiliation  Physiotherapy School and Centre Seth G S Medical College and KEMH 
Address  Room No 16, Ground Floor, CVTC Building, Physiotherapy School and Centre Seth G S Medical College and KEMH, Parel East, Mumbai, Maharashtra- 400012


MAHARASHTRA
400012
India 
Phone  9820191106  
Fax    
Email  mpjiandani@gmail.com  
 
Details of Contact Person
Public Query  
Name  Shravani Kale 
Designation  Executive Cardiopulmonary Physiotherapist 
Affiliation  Pratibha Prabhakar Pulmonary Rehabilitation Centre 
Address  1st floor, Divyajyot CHS Ltd., Building No. 8, Above HDFC Bank, S. V. Road, Goregaon (West)- Mumbai, Maharashtra-400104

Mumbai
MAHARASHTRA
400104
India 
Phone  9833665984  
Fax    
Email  kale.shravani11@gmail.com  
 
Source of Monetary or Material Support  
Physiotherapy School and Centre Seth G S Medical College and KEMH 
Pratibha Prabhakar pulmonary Rehabilitation Centre 
 
Primary Sponsor  
Name  Pratibha Prabhakar Pulmonary Rehabilitation Centre 
Address  1st Floor, Divyajyot CHS Ltd., Building No 8, Above HDFC bank, S. V. Road, Goregaon (West), Mumbai, Maharashtra-400104 
Type of Sponsor  Private hospital/clinic 
 
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 
Shravani kale  Pratibha Prabhakar Pulmonary Rehabilitation Centre  1st floor, Divyajyot CHS Ltd., Building No. 8, Above HDFC Bank, S. V. Road, Goregaon (West), Mumbai, Maharashtra-400104
Mumbai
MAHARASHTRA 		 9833665984

kale.shravani11@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Seth G S Medical institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J849||Interstitial pulmonary disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NILL  NILL 
Comparator Agent  NILL  NILL 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Diagnosed with any type of ILD by a chest physician
2. Subjects free from respiratory symptoms with no respiratory diagnosis.  
 
ExclusionCriteria 
Details  1. Individuals with active arthritis, severe osteoporosis and using walking aid
2. Individuals who had a hospitalization or exacerbation in the last 4 weeks
3. Individuals who are currently undergoing Pulmonary Rehabilitation Program and have
completed more than 2 weeks already
4. Individuals who completed Pulmonary Rehabilitation Program in less than last 1 year
5. Individuals having any musculoskeletal or neurological condition, diabetic or other types
of neuropathy
6. Known Psychiatric illness
7. Not willing to participate. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Brief BESTest total score
 		 One-time assessment at baseline
 
 
Secondary Outcome  
Outcome  TimePoints 
ABC scale total score  One-time assessment at baseline 
 
Target Sample Size   Total Sample Size="128"
Sample Size from India="128" 
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)   11/10/2024 
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="0"
Months="11"
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   The patients with ILD, experience  respiratory symptoms such as exertional dyspnoea, dry cough, exercise intolerance, fatigue, exercise-induced hypoxemia which in certain cases progresses to hypoxemia at rest as the disease progresses, leading to the requirement of Long Term Oxygen Therapy (LTOT) and extrapulmonary impairments such as skeletal and respiratory muscle dysfunction, reduced bone mineral density and osteoporosis. The use of supplemental oxygen and, the prevalence of LTOT use have been suggested to make the patients with chronic respiratory diseases more susceptible to falls and can result in serious fall-related complications with delayed recovery. Hence we find it necessary to assess balance in patients with ILD. 
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