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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  
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 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  
Status 
Not Applicable 
 
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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