| CTRI Number |
CTRI/2024/02/063008 [Registered on: 21/02/2024] Trial Registered Prospectively |
| Last Modified On: |
21/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparing chest expansion in two different shoulder positions and to
find the normative value of chest expansion in South Indian Adult population |
|
Scientific Title of Study
|
Comparison of chest expansion in two different shoulder positions and determination of reference value in South Indian adult population |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SWEATHA NATHAN R |
| Designation |
PG Student |
| Affiliation |
Sri Ramachandra Institute Of Higher Education and Research |
| Address |
Faculty of physiotherapy,
Sri Ramachandra college,
No.1 Ramachandra Nagar Porur, Chennai - 600 116
Chennai
TAMIL NADU
600087
India |
| Phone |
7358734499 |
| Fax |
|
| Email |
sweatha220499@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
MRSSRIDEVI S |
| Designation |
Associate Professor |
| Affiliation |
Sri Ramachandra Institute Of Higher Education and Research |
| Address |
1st floor, Faculty of Physiotherapy, Sri Ramachandra college,
No.1 Ramachandra Nagar, Porur, Chennai
Chennai
TAMIL NADU
600 116
India |
| Phone |
9841401565 |
| Fax |
|
| Email |
devibsmoorthy@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
MRSSRIDEVI S |
| Designation |
Associate Professor |
| Affiliation |
Sri Ramachandra Institute Of Higher Education and Research |
| Address |
1st floor, Faculty of Physiotherapy, Sri Ramachandra college,
No.1 Ramachandra Nagar, Porur, Chennai
TAMIL NADU
600 116
India |
| Phone |
9841401565 |
| Fax |
|
| Email |
devibsmoorthy@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute Of Higher Education And Research, Porur, Chennai-600116 |
|
|
Primary Sponsor
|
| Name |
SWEATHA NATHAN R |
| Address |
No.1 Ramachandra Nagar Porur, Chennai - 600 116 |
| Type of Sponsor |
Other [SELF ] |
|
|
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 SWEATHAN NATHAN R |
Sri Ramachandra Institute Of Higher Education And Research |
Faculty of Physiotherapy , Sri Ramachandra College, No.1 Ramachandra Nagar Porur, Chennai - 600 116
Chennai
TAMIL NADU |
7358734499
sweatha220499@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE FOR STUDENTS PROJECT |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Not applicable |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Participants with Nil respiratory dysfunction |
|
| ExclusionCriteria |
| Details |
Respiratory dysfunctions |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find the normative values of Chest expansion |
NIL
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| WAIST HIP RATIO |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="450"
Sample Size from India="450"
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)
|
03/03/2024 |
| 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="5"
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
|
Normal chest expansion is vital for respiratory system function and
tissues oxygenation and this depend on the presence of effective normal
thoracic cage mobility and healthy lung, any disorder that interferes with
chest expansion will affect the oxygen supply to the vital organs of the body .Evaluation of chest expansion is an important
step in physical examination of respiratory system. Assessing for chest
expansion provides clues regarding the presence of chest wall pathology,
lung volume loss or obstruction. Measurement of thoracic expansion with an inch tape is a reliable objective outcome measure in
patients having respiratory diseases and also in normal subjects for assessing
their respiratory status. (Brockenhurst SE et al., 2017). Chest expansion can
be done at three levels - 2nd,4th ICS and xiphoid level (Debouche S et al., 2016).OBJECTIVES WITH JUSTIFICATION :
1. The chest expansion would
assessed with shoulder in different positions by assessors. This change in
shoulder position may influence the
chest expansion , in literature search we found lacunae in this view point hence this study was taken up to find out whether
the shoulder position influences the chest expansion.
2.There is a vast discrepancy in
practice to use reference values and there is no specific reference data on
chest expansion available for young adults of South India. Hence ,this study would
be done to measure the chest expansion and to establish reference equation for
chest expansion in healthy young South Indian adults, understanding relation
of age, height ,weight and BMI with chest expansion.
|