| CTRI Number |
CTRI/2024/03/063873 [Registered on: 08/03/2024] Trial Registered Prospectively |
| Last Modified On: |
07/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Pre and Post effect of deep breathing exercises among construction site workers in Chennai District |
|
Scientific Title of Study
|
Effectiveness of deep breathing exercises on peak expiratory flow rate among construction site workers in Chennai District- A Quasi-experimental 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 |
Dr Priya P |
| Designation |
Post Graduate |
| Affiliation |
Saveetha Medical College |
| Address |
Department of Community Medicine
Saveetha Medical College
Thandalam
Chennai
Chennai
TAMIL NADU
602105
India |
| Phone |
7358238037 |
| Fax |
|
| Email |
priyasarathi17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Selvaraj I |
| Designation |
Professor |
| Affiliation |
Saveetha Medical College |
| Address |
Department of Community Medicine
Saveetha Medical College
Thandalam
Chennai
Chennai
TAMIL NADU
602105
India |
| Phone |
9840676545 |
| Fax |
|
| Email |
iselvarajirms@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priya P |
| Designation |
Post Graduate |
| Affiliation |
Saveetha Medical College |
| Address |
Department of Community Medicine
Saveetha Medical College
Thandalam
Chennai
Chennai
TAMIL NADU
602105
India |
| Phone |
7358238037 |
| Fax |
|
| Email |
priyasarathi17@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Medical College and Hospital Thandalam |
|
|
Primary Sponsor
|
| Name |
Dr Priya P |
| Address |
Saveetha Medical College and hospital Thandalam Chennai |
| 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 Priya P |
Saveetha Urban Health Centre |
Department of Community Medicine, Urban Health Training Centre, Thirumazhisai, Thiruvaluur District.Room no-10
Chennai
TAMIL NADU |
7358238037
priyasarathi17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Medical College and Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Respiratory morbidity among construction site workers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Deep breathing exercises |
Pre-Intervention phase
•Initially 140 construction site workers will be assessed using Pre- tested semi structured questionnaire and respiratory morbidity will be assessed by St. George’s Respiratory Questionnaire and Peak expiratory flow rate. The training on Deep breathing exercise (Diaphragmatic Breathing Technique) will be provided for four groups. Each group consists of 35 workers Duration of Intervention is 8 weeks. After that participants will undergo a post Intervention phase to assess the effectiveness of Intervention. Total Duration of Intervention is 8 weeks. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1)Construction site workers aged above 20 years
2)More than two years exposure at construction site 3)working at least 6 hours per day and 5 days per week
4)All designations at construction site |
|
| ExclusionCriteria |
| Details |
1)Construction site workers aged above 50
years
2)clinical abnormalities of
vertebral column and thoracic cage pulmonary tuberculosis emphysema and other
respiratory diseases
3)Abdominal and Chest surgery |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Positive effect of deep breathing exercise to the PEFR grades in construction site workers |
Pre-Intervention phase is 2 weeks. Intervention phase is 8 weeks.Post-Intervention phase is 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Prevalence of respiratory morbidity among construction workers |
Time duration is 2 weeks |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
16/03/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
16/03/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
Once the trial has been completed and results have been computed , a manuscript will be prepared and sent for publication |