| CTRI Number |
CTRI/2025/07/091148 [Registered on: 18/07/2025] Trial Registered Prospectively |
| Last Modified On: |
17/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
How Smoking Affects the Lungs After COVID-19 |
|
Scientific Title of Study
|
Association Of Lung Parameters With Smoking Among Covid 19 Survivors. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shraddha Deshmukh |
| Designation |
Post graduate student |
| Affiliation |
SDM college of physiotherapy |
| Address |
OPD no 13,
Department of Cardio respiratory disorders, SDM College of physiotherapy,Manjushree nagar, Sattur, Dharwad,
Karnataka 580009, India
Dharwad KARNATAKA 580009 India |
| Phone |
9686095410 |
| Fax |
|
| Email |
shraddhadeshmukh801@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Shraddha Deshmukh |
| Designation |
Post graduate student |
| Affiliation |
SDM college of physiotherapy |
| Address |
OPD no 13,
Department of Cardio respiratory disorders, SDM College of physiotherapy,Manjushree nagar, Sattur, Dharwad,
Karnataka 580009, India
Dharwad KARNATAKA 580009 India |
| Phone |
9686095410 |
| Fax |
|
| Email |
shraddhadeshmukh801@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Shubha Akadas |
| Designation |
Assistant professor and PG guide |
| Affiliation |
SDM college of physiotherapy |
| Address |
OPD no 13, Department of Cardio-respiratory disorders, SDM
College Of Physiotherapy, Manjushree nagar, Sattur, Dharwad,
Karnataka 580009, India
Dharwad KARNATAKA 580009 India |
| Phone |
973948807 |
| Fax |
|
| Email |
shubha.akadas@sdmuniversity.edu.in |
|
|
Source of Monetary or Material Support
|
| SDM College Of Physiotherapy Manjushree Nagar, Sattur, Dharwad-580009, Karnataka, India. |
|
|
Primary Sponsor
|
| Name |
Shraddha Deshmukh |
| Address |
SDM College Of Physiotherapy SDM College Of Medical Sciences
And Hospital Manjushree Nagar Sattur Dharwad Karnataka 580009 |
| 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 |
| Shraddha Deshmukh |
Shri Dharmasthala Manjunatheshwara hospital |
Cardiorespiratory
Department OPD no 13
Manjushree Nagar
Sattur Dharwad
Karnataka
Dharwad 580009
KARNATAKA Dharwad KARNATAKA |
9686095410
shraddhadeshmukh801@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-SDM College Of Medical Sciences And Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
COVID 19 survivors |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Individuals who have been tested positive for covid 19 and recovered over 1 yr.
2. All genders will be included.
3. Patient of age group between 18 to 50 years.
4. Smokers and non-smokers
5. Individuals with stable comorbidities like Hypertension, Diabetes mellitus, chronic kidney disease with precaution and on medication.
6. Individuals who are willing to participate in the study.
7. Individuals who can communicate. |
|
| ExclusionCriteria |
| Details |
1. Individual with pre-existing severe lung condition (eg- COPD, asthma).
2. Individuals with existing neurological conditions.
3. Uncooperative/individuals who do not give their consent.
4. Individuals with locomotive disorders.
5. Individuals who have had recent thoracic, cardiac or abdominal surgery. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Smokers who have had COVID-19: FEV1/FVC ratio may be significantly reduced and may indicate obstructive lung disease |
After Screening The Inclusion And exclusion Criteria. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Peak expiratory flow rate |
After Screening The Inclusion And Exclusion Criteria |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
12/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
12/09/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="0" 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
|
This study investigates the long-term effects of COVID-19 on lung function and Peak Expiratory Flow Rate (PEFR) in smokers versus non-smokers. COVID-19, known to affect the respiratory system severely, has led to persistent pulmonary complications, including fibrosis and reduced lung function. Smokers are already at increased risk due to pre-existing lung damage, making it essential to understand their post-COVID recovery. The study aims to assess and compare lung function using spirometry (FEV1, FVC) and PEFR in individuals aged 18–50 who recovered from COVID-19 at least one year ago. By comparing smokers and non-smokers, it will help identify whether smoking exacerbates long-term pulmonary impairment after COVID-19. The study uses a cross-sectional observational design with a sample size of 100, applying simple random sampling. It aims to provide evidence to support smoking cessation and tailored pulmonary rehabilitation strategies. The novelty lies in its focus on long-term post-COVID lung changes in a healthy, working-age population—an area not well studied. Findings are expected to benefit clinical practice, guide public health interventions, and inform patient education by emphasizing the importance of smoking cessation in improving lung recovery and reducing the risk of long COVID-related respiratory dysfunction.
|