| CTRI Number |
CTRI/2025/04/085202 [Registered on: 21/04/2025] Trial Registered Prospectively |
| Last Modified On: |
02/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Checking the pulmonary functions in traffic police - officers |
|
Scientific Title of Study
|
Correlation between peak expiratory flow rate and single breath count test in traffic - policemen. |
| 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 Daman Preet Singh |
| Designation |
Assistant Professor |
| Affiliation |
Saket college of physiotherapy ,chandimandir, panchkula |
| Address |
Room no.63 ,Saket College Of Physiotherapy, Chandimandir, Panchkula, Haryana.
Panchkula
HARYANA
134107
India |
| Phone |
9872858169 |
| Fax |
|
| Email |
dpsingh.gmch@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Daman Preet Singh |
| Designation |
Assistant Professor |
| Affiliation |
Saket college of physiotherapy ,chandimandir, panchkula |
| Address |
Room no.63 ,Saket College Of Physiotherapy, Chandimandir, Panchkula, Haryana.
Panchkula
HARYANA
134107
India |
| Phone |
9872858169 |
| Fax |
|
| Email |
dpsingh.gmch@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sukirti |
| Designation |
Student MPT(Cardiopulmonary) |
| Affiliation |
Saket college of physiotherapy ,chandimandir, panchkula |
| Address |
Room no. 55,college of rehabilitation center Saket College Of Physiotherapy, Chandimandir, Panchkula.
Panchkula
HARYANA
134107
India |
| Phone |
7027020675 |
| Fax |
|
| Email |
sukirtiporiya@gmail.com |
|
|
Source of Monetary or Material Support
|
| I will myself bear the other cost required. Address- Sukirti, (MPT Student), Room no.- 55, college of rehabilitation center, Saket college of physiotherapy, chandimandir, panchkula, Haryana.
Pincode - 134107 |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [nil] |
|
|
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 Sukirti Poriya |
Traffic police officers in Panchkula , Chandigarh ,Mohali |
traffic police officers in the commissioner of police of Panchkula ,office of inspectopr admn traffic,traffic lines,sector 29,Chandigarh ,suprintendent of police (traffic) distt. sas nagar, Mohali
Panchkula
HARYANA |
7027020675
sukirtiporiya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| from panchkula ,chandigarh,mohali traffic police office |
Approved |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy participants
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Male |
| Details |
Inclusion criteria
1. Traffic policemen working in the tricity area.
2. Age range (e.g., 20-55 years)
3. Ability to understand and perform the required respiratory function tests (PEFR measurement and single breath count) effectively.
4. Willingness to participate in the study and provide informed consent.
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria
1. Participants having any pre-existing respiratory diseases (e.g., asthma, chronic obstructive pulmonary disease).
2. Participants having any history of significant respiratory tract infection within a specified timeframe (e.g., within the past 15days) that could affect respiratory function.
3. Any co-morbidities or medical conditions that could affect the respiratory function.
4.Currently taking medications or treatments that could affect respiratory function (e.g., bronchodilators, corticosteroids).
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Outcome measures
1.Value of single breath count
2.Peak expiratory flow rate
3.Correlation between Peak expiratory flow rate and Single Breath Count
|
immediate after testing
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/04/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
28/04/2025 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Results The mean age of participants was 40.39 ± 9.05 years, mean height 174.77 ± 5.02 cm, mean weight 81.00 ± 13.33 kg, and mean BMI 26.52 ± 4.24 kg/m². The mean PEFR was 520.91 ± 106.75 L/min and mean SBCT was 67.73 ± 16.23 counts. Both parameters were significantly lower in smokers than in non-smokers (p < 0.001). Pearson’s correlation showed a strong positive relationship between PEFR and SBCT (r = 0.752, p < 0.001). Age demonstrated a negative correlation with both PEFR (r = -0.305, p = 0.002) and SBCT (r = -0.345, p < 0.001), while height correlated positively with PEFR (r = 0.289, p = 0.004). No significant associations were observed for weight or BMI. Discussion This study demonstrated a strong positive correlation between PEFR and SBCT among traffic policemen, suggesting that SBCT can serve as a reliable and inexpensive proxy for pulmonary function assessment. The findings align with previous research by Bhandare et al. (2021), who found a similar relationship in healthy adults. The reduced PEFR and SBCT values among smokers underscore the deleterious effects of tobacco on respiratory function, consistent with studies by Gupta et al. (2011) and Pajanivel et al. (2013). The negative correlation between age and pulmonary indices reflects age-related declines in lung elasticity and muscle strength. Height showed a positive influence, likely due to larger thoracic volume and vital capacity. The absence of BMI effects may be explained by moderate weight distribution in the cohort. Overall, SBCT proves to be a simple, rapid, and non - invasive alternative respiratory assessment tool in resource limited occupational settings. |