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CTRI Number  CTRI/2023/09/057877 [Registered on: 20/09/2023] Trial Registered Prospectively
Last Modified On: 19/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Association between body composition, muscle strength and functional performance in subjects with chronic lung disease in dakshina kannada; A Cross-sectional Study 
Scientific Title of Study   Association Between Body Composition, Muscle Strength, and Functional Performance In Subjects With Chronic Lung Disease In Dakshina Kannada. 
Trial Acronym  nil  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sahana S 
Designation  PG Student 
Affiliation  Kasturba Medical College,Department of Physiotherapy, Mangalore.,MAHE 
Address  Kasturba Medical College, Department of Physiotherapy Bejai, Mangalore, Dakshina Kannada. Karnataka.

Dakshina Kannada
KARNATAKA
575004
India 
Phone  7795448517  
Fax    
Email  sahana10598@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mr Shyam Krishnan K 
Designation  Assistant Professor - Senior Scale 
Affiliation  Kasturba Medical College,Department of Physiotherapy, Mangalore.,MAHE 
Address  Kasturba Medical College, Department of Physiotherapy Bejai, Mangalore, Dakshina Kannada. Karnataka.

Dakshina Kannada
KARNATAKA
575004
India 
Phone  9880072564  
Fax    
Email  krish.shyam@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Mr Shyam Krishnan K 
Designation  Assistant Professor - Senior Scale 
Affiliation  Kasturba Medical College,Department of Physiotherapy, Mangalore. 
Address  Kasturba Medical College, Department of Physiotherapy Bejai, Mangalore, Dakshina Kannada. Karnataka.

Dakshina Kannada
KARNATAKA
575004
India 
Phone  9880072564  
Fax    
Email  krish.shyam@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Medical College,Bejai, Mangalore. Dakshina Kannada 
 
Primary Sponsor  
Name  Kasturba Medical College  
Address  Department of Physiotherapy, Kasturba Medical College, Center for Basic Sciences, Bejai, Mangalore- 575 004  
Type of Sponsor  Private medical college 
 
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 
Mr Shyam Krishnan K  KMC hospital  KMC Attavar,KMC Jyoti. Department of Physiotherapy. Mangalore. Dakshina Kannada. Karnataka
Dakshina Kannada
KARNATAKA 		 9880072564

krish.shyam@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Kasturba Medical College, Mangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J440||Chronic obstructive pulmonary disease with acute lower respiratory infection,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Subjects of any gender, in the age group 18 years and above
Ability to ambulate independently.
 
 
ExclusionCriteria 
Details  Subjects with co-existing musculoskeletal, neurological, and cardiovascular conditions limiting functional performance to know diagnosis of malignancies.
Subject with severe acute exacerbation with severely limited exercise tolerance.
Subject with poor cognitive ability as indicated by MOCA or mini-COG
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Karada Bio-electrical impedance analyzer
Microfet handheld dynamometer
Six-minute walk test
Respiratory pressure meter 		 Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="28"
Sample Size from India="28" 
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)   05/10/2023 
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  

In this study, Analysis of body composition such as body weight, body fat percentage, BMI, segmental subcutaneous fat, skeletal muscle percentage, resting metabolism, visceral fat level, and body age will be done using KARADA Bioelectrical Impedance Analyser. Measurement of peripheral muscle strength of lower extremity muscle groups will be done by using a Microfet handheld dynamometer. Subjects will be assessed for respiratory muscle strength, i.e, maximal inspiratory pressure(PIMax) and maximal expiratory pressure(PEMax) using MicroRPM. Functional performance will be assessed using a six-minute walk test. The data collected will be statistically analysed and the results interpreted will be measured accordingly.

The study helps in understanding the association between physical performance and variables of muscle strength and body composition will help in exploring multifactorial intervention programmes for the restoration of functional performance in people with chronic lung disease.

 
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