| CTRI Number |
CTRI/2024/04/065354 [Registered on: 08/04/2024] Trial Registered Prospectively |
| Last Modified On: |
05/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Breathing Exercises] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Lung Health & Well-being in PVC Workers: Breathing Exercises & Training Study |
|
Scientific Title of Study
|
Impact of breathing exercises and occupational health training on lung functions and psychological parameters in Polyvinylchloride factory workers: A Randomized controlled trial |
| 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 Kumar Vikram |
| Designation |
Postgraduate student in Physiology department, University college of medical Sciences, Delhi |
| Affiliation |
University College of Medical Sciences & Guru Teg Bahadur Hospital |
| Address |
Department of Physiology University College of Medical Sciences & Guru Teg Bahadur Hospital, Dilshad garden
Dilshad Garden
North East
DELHI
North East DELHI 110095 India |
| Phone |
7762071464 |
| Fax |
|
| Email |
vikram.kumar961@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Farah Khaliq |
| Designation |
Director Professor and Head in Physiology department, University college of medical Sciences, Delhi |
| Affiliation |
University College of Medical Sciences & Guru Teg Bahadur Hospital |
| Address |
Room no. 116, Department of Physiology, University College of Medical Sciences & Guru Teg Bahadur Hospital, Dilshad garden
Dilshad Garden
North East
DELHI
North East DELHI 110095 India |
| Phone |
9811907770 |
| Fax |
|
| Email |
farahphysioucms@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Kumar Vikram |
| Designation |
Postgraduate student in Physiology department, University college of medical Sciences, Delhi |
| Affiliation |
University College of Medical Sciences & Guru Teg Bahadur Hospital |
| Address |
Department of Physiology University College of Medical Sciences & Guru Teg Bahadur Hospital, Dilshad garden
Dilshad Garden
North East
DELHI
North East DELHI 110095 India |
| Phone |
7762071464 |
| Fax |
|
| Email |
vikram.kumar961@gmail.com |
|
|
Source of Monetary or Material Support
|
| Principal, University college of medical Sciences, Delhi |
|
|
Primary Sponsor
|
| Name |
Principal |
| Address |
University College of Medical Sciences & Guru Teg Bahadur Hospital, Dilshad Garden, Delhi- 110095 |
| Type of Sponsor |
Government 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 Kumar Vikram |
University College of Medical Sciences & Guru Teg Bahadur Hospital |
Dilshad Garden, Delhi
110095 North East DELHI |
7762071464
vikram.kumar961@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE – HUMAN RESEARCH (IEC-HR) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
EXPOSED TO PVC |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Breathing Exercises and occupational health training |
1 They will be performed under the expert guidance of breathing exercises instructor for at least twice/week. In addition, we will provide breathing exercises video so that they can practice daily at home by self.
2 To determine if the participants are performing breathing exercises correctly, we will check in with them once a week for up to 12 weeks.
3 Occupational health training will be provided (advice on nutrition,sleep,protective measures,manual material handling,Knowledge of potential hazards and their prevention)
|
| Comparator Agent |
Control Group |
They will not receive the intervention and will continue with their usual work routines.Follow up after 3 months. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Male |
| Details |
Healthy adult males in the age group of 20-40 years working in a PVC factory for at least 1 year will be recruited for the study. |
|
| ExclusionCriteria |
| Details |
Participants with the following conditions will be excluded:
1 Any chronic illness.
2 On any medication.
3 Already performing breathing exercises or any other deep breathing exercises.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in lung function parameters. |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in psychological parameters (Anxiety, Depression and Stress score). |
3 months |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
16/04/2024 |
| 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="1" Months="5" 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
|
Study title: Impact of breathing exercises and occupational health training on
lung functions and psychological parameters in Polyvinyl Chloride factory
workers: A Randomized controlled trial.
Rationale: Polyvinyl Chloride factory
workers are exposed to various occupational hazards such as airborne pollutants
and respiratory irritants. Investigating the effects of breathing exercises and
occupational health training may reveal preventive measures that can mitigate
the negative consequences of occupational exposures, ultimately reducing the
risk of respiratory issues and psychological distress among PVC workers.
Aim: To assess and enhance the
respiratory health and psychological well-being of PVC factory workers through
the implementation of a comprehensive intervention program involving breathing
exercises and occupational health training.
Primary objectives:
To design and implement a structured intervention
program combining breathing exercises and occupational health training,
tailored to the specific needs of PVC factory workers.
To evaluate
changes in respiratory health due to the intervention of breathing exercises and occupational health training
in PVC factory workers.
To evaluate
changes in psychological parameters due to the intervention of breathing exercises and occupational health training
in PVC factory workers.
Secondary objectives:
To explore correlations between changes in lung
functions and psychological well-being.
To draw conclusions based on the study findings and
provide recommendations for the development and implementation of future
occupational health programs in PVC factories
Setting: Subjects will be recruited from PVC factory, Jhilmil Industrial
Area, Delhi-95.
Study design: Prospective & intervention study
Time frame: April 2024 to August 2025
Population/participants: Healthy adult males in the age group of 20 – 40 years working in a PVC factory for at least 1 year.
Sample size: 60 (30 in each group)
Methods: All the participants included in this study will undergo complete
physical, clinical and anthropometric assessment; prior to participation. After
the clinical evaluation is complete, the study participants who fulfill the
inclusion criteria and who sign the informed consent will be recruited for the
study. Participants will be randomly assigned to
either the intervention group or the control group by using a
computer-generated random number sequence.
Intervention Group: They will receive a structured
intervention program consisting of breathing exercises and occupational health
training. The intervention will be delivered for 3 months.
Control Group: They will not receive the intervention and will
continue with their usual work routines.
Both groups will be subjected to pre and
post-intervention assessments of lung functions and psychological parameters.
Outcome
measures:
Change in lung
function parameters after 3 months.
Change in psychological
parameters (Anxiety, Depression and Stress score) after 3 months.
Statistical
analysis: Analysis
will be done by the SPSS 20.0 statistic package. Within the group and between
the group comparisons will be done by Repeated measure ANOVA followed by
TUKEY’S test. P value of less than 0.05 will be considered significant.
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