| CTRI Number |
CTRI/2024/05/067354 [Registered on: 15/05/2024] Trial Registered Prospectively |
| Last Modified On: |
21/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding How Lung Tests Relate to the Health and wellness of College Students
|
|
Scientific Title of Study
|
Correlation of pulmonary functions with health related quality of life among college students |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chinmayi M |
| Designation |
Post graduate student |
| Affiliation |
Nitte institute of physiotherapy |
| Address |
Department of Physiotherapy, Room number 20, second base division, NITTE Institute of Physiotherapy, NITTE (Deemed to be University), Deralakatte, Mangaluru, Karnataka 575018, India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9900129302 |
| Fax |
|
| Email |
Chinmayikumar12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Abeeshna Ashok |
| Designation |
Assisstant professor |
| Affiliation |
Nitte institute of physiotherapy |
| Address |
Department of Physiotherapy, Room number 20, second base division, NITTE Institute of Physiotherapy, NITTE (Deemed to be University), Deralakatte, Mangaluru, Karnataka 575018, India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9895724380 |
| Fax |
|
| Email |
abeeshnaashok@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Abeeshna Ashok |
| Designation |
Assisstant professor |
| Affiliation |
Nitte institute of physiotherapy |
| Address |
Department of Physiotherapy, Room number 20, second base division, NITTE Institute of Physiotherapy, NITTE (Deemed to be University), Deralakatte, Mangaluru, Karnataka 575018, India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9895724380 |
| Fax |
|
| Email |
abeeshnaashok@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| Department of physiotherapy, room number 20, second base division, Justice K.S Hegde charitable Hospital, Medical science complex, Deralakatte, Mangaluru 575018 Dakshinna Kannada KARNATAKA |
|
|
Primary Sponsor
|
| Name |
Nitte Deemed to be University |
| Address |
Department of Physiotherapy, Room number 20, second base division, NITTE Institute of Physiotherapy, NITTE (Deemed to be University), Deralakatte, Mangaluru, Karnataka 575018, India |
| Type of Sponsor |
Research institution |
|
|
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 |
| Chinmayi M |
Nitte Institute of Physiotherapy |
Department of Physiotherapy, Room number 20, second base division, NITTE Institute of Physiotherapy, NITTE (Deemed to be University), Deralakatte, Mangaluru, Karnataka 575018, India
Dakshina Kannada
KARNATAKA |
9900129302
Chinmayikumar12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of NITTE Institute of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
college students |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Students of NITTE Deemed to be University aged between 18-25 years
Volunteers willing to participate in pulmonary function testing
individuals who fall into category I and II of IPAQ score (inactive and minimally active) |
|
| ExclusionCriteria |
| Details |
Students who are not willing to take part in the study
Students with any previous cardiovascular symptoms
Students with any pulmonary disorders
Orthopaedic and neuromuscular diseases affecting thoracic pump function
Students with any chest wall deformities
Students who smoke (current smokers and those who have stopped smoking before 6 months)
Exclusion based on PFT (where FEV1 80% or more is considered normal for obstructive conditions and total lung capacity 80% or less is considered for restrictive lung diseases) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pulmonary function test |
Pulmonary function test will be performed in one session |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| SF 36 (36-item Short Form Health Survey) |
SF 36 will be assessed in baseline |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2024 |
| Date of Study Completion (India) |
31/12/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/12/2024 |
|
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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Quality of life encompasses various aspects of well-being, including emotional responses, outlook, fulfillment, and satisfaction with work and relationships. Health-related quality of life (HRQoL) is a key component, reflecting perceptions of physical and mental well-being over time. Social interactions and mental health play a significant role in college students’ performance and learning. The SF-36 survey is commonly used to assess health related quality of life (HRQoL), measuring eight dimensions of health and well-being. Pulmonary function tests (PFTs), particularly spirometry, are important for assessing lung health and can be influenced by lifestyle factors like exercise and sedentary behavior. A previous study found out that poorer PFT performance in sedentary individuals compared to athletes. College students’ physical activity levels impact their quality of life, and thus this study aims to explore the correlation between pulmonary function and health related quality of life in college students. |