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CTRI Number  CTRI/2024/02/062568 [Registered on: 13/02/2024] Trial Registered Prospectively
Last Modified On: 16/04/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   is there any association between Chest Expansion and Pulmonary Function Testing in healthy children in 8 – 15 years of age group 
Scientific Title of Study   Association between Chest Expansion and Pulmonary Function Testing in healthy children in 8 – 15 years of age 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  ADITI L SOMAN 
Designation  assistant professor, Department of Kinesiotherapy 
Affiliation  DECCAN EDUCATION SOCIETYS BRIJLAL JINDAL COLLEGE OF PHYSIOTHERAPY, PUNE 
Address  DECCAN EDUCATION SOCIETYS BRIJLAL JINDAL COLLEGE OF PHYSIOTHERAPY, DEPARTMENT OF KINESIOTHERAPY, GROUND FLOOR FERGUSSON COLLEGE CAMPUS,

Pune
MAHARASHTRA
411004
India 
Phone  08788123192  
Fax    
Email  aditi.soman@despune.org  
 
Details of Contact Person
Scientific Query
 
Name  ADITI L SOMAN 
Designation  assistant professor, Department of Kinesiotherapy 
Affiliation  DECCAN EDUCATION SOCIETYS BRIJLAL JINDAL COLLEGE OF PHYSIOTHERAPY, PUNE 
Address  DECCAN EDUCATION SOCIETYS BRIJLAL JINDAL COLLEGE OF PHYSIOTHERAPY, DEPARTMENT OF KINESIOTHERAPY GROUND FLOOR FERGUSSON COLLEGE CAMPUS,

Pune
MAHARASHTRA
411004
India 
Phone  08788123192  
Fax    
Email  aditi.soman@despune.org  
 
Details of Contact Person
Public Query
 
Name  ADITI L SOMAN 
Designation  assistant professor, Department of Kinesiotherapy 
Affiliation  DECCAN EDUCATION SOCIETYS BRIJLAL JINDAL COLLEGE OF PHYSIOTHERAPY, PUNE 
Address  DECCAN EDUCATION SOCIETYS BRIJLAL JINDAL COLLEGE OF PHYSIOTHERAPY, FERGUSSON COLLEGE CAMPUS, DEPARTMENT OF KINESIOTHERAPY, GROUND FLOOR

Pune
MAHARASHTRA
411004
India 
Phone  08788123192  
Fax    
Email  aditi.soman@despune.org  
 
Source of Monetary or Material Support  
self and the study will be done in Deccan Education Societys Golwalkar primary school in pune city 
 
Primary Sponsor  
Name  NIL 
Address  self funded 
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 
Dr Aditi Laukik Soman  DECCAN EDUCATION SOCIETYS BRIJLAL JINDAL COLLEGE OF PHYSIOTHERAPY  Department of Kinesiotherapy Deccan Education Societys Brijlal Jindal Physiotherapy, Fergusson college campus.
Pune
MAHARASHTRA 
08788123192

aditi.soman@despune.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
DECCAN EDUCATION SOCIETYS BRIJLAL JINDAL COLLEGE OF PHYSIOTHERAPY ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Normal healthy children 8-15 years of age 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  8.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  Healthy children between 8 – 15 years of age.
Boys and girls having normal BMI
 
 
ExclusionCriteria 
Details  History of cardiac, respiratory, musculoskeletal, neurological diseases, cognitive deficits, any abdominal or thoracic surgery in past 1year, spinal deviations, thoracic cage deformities, acute or chronic cough, cold, fever. 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
CHEST EXPANSION  DAY 1 
 
Secondary Outcome  
Outcome  TimePoints 
SPIROMETRY  DAY 1 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="85" 
Phase of Trial   N/A 
Date of First Enrollment (India)   08/03/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="0"
Days="15" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
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  

There is difference between the normal adult and paediatric respiratory system with respect to the anatomical and physiological development of lung. The cross-sectional shape of the infant thorax is cylindrical and not elliptical as in adolescents or adults. Cartilaginous and extremely compliant chest wall of newborn allows necessary distortion of the infant’s thorax to travel through the birth canal. The rib cage of an infant has more horizontal alignment of the ribs compared to the oblique configuration of ribs seen in adults leading to a variation in the biomechanics. Normally, the process of inspiration is active and that of expiration is passive. This occurs as the pump handle movement is seen in the upper thorax while bucket handle movement is seen in lower thorax. With inspiration, there is pump handle movement which causes an increase in the antero-posterior diameter of thorax, while in the bucket handle movement there is an increase in the transverse diameter of the lower thorax. Movement of the ribs occur at costotransverse and the costovertebral joints. Orientation of these joints varies in the upper and lower ribs.  The transverse diameter is greater than the antero-posterior diameter giving it an ellipsoid shape with the ratio 7:5. Development of alveoli in lungs continues and is completed by 10 years of age. Most of this development occurs in 1st 6 months of life. The number of alveoli increases with height. 

Normal chest wall mobility is important for effective lung expansion and subsequent ventilation. Respiratory evaluation is an integral part of chest physiotherapy.

Pulmonary function tests are objectively used to measure an

individual’s ability to breathe and also measures how well the lungs ventilate and exchange gas. It is used to measure forced vital capacity (FVC), Forced expiratory volume(FEV) and some other components. Spirometry is an objective measure to assess or monitor disease progression and deterioration during acute exacerbation, the efficiency of an inhaled drug or its delivery system. It is a procedure that measures the rate of change in lung volumes during forced breathing manoeuvres and is also used to determine diagnosis, prognosis and monitor and manage patients with respiratory diseases. Parameters like age, sex, environmental factors, ethnicity, prematurity, patient cooperation and effort affect the results of spirometry. To arrive at a diagnosis, the result of pft should be combined with patient information and symptoms. A Belgian study demonstrated that expert panels could reach 77% accuracy when predicting diagnosis on clinical history and pft reports alone.

There is no evidence suggesting correlation between chest expansion in adults and pulmonary function testing in healthy adults. Normative values of chest expansion in paediatrics and adults are different. This leads to different results in correlation with other interventions. Therefore, there is a need to study paediatric respiratory system differently. Normative values of chest expansion values in paediatrics were known but there’s no evidence regarding its reliability. Hence aim is to find out correlation of chest expansion with pulmonary function tests especially among young, healthy individuals.

 
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