| 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
|
|
|
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
|
|
|
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. | |