| CTRI Number |
CTRI/2024/09/074527 [Registered on: 30/09/2024] Trial Registered Prospectively |
| Last Modified On: |
25/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Relationship between lung health and quality of life with physical activity among middle aged adults |
|
Scientific Title of Study
|
Correlation of changes in
physical activity levels on pulmonary function and quality of life among middle aged adults |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kalpana Verma |
| Designation |
Student |
| Affiliation |
Chhatrapati Shahu Ji Maharaj University Kanpur |
| Address |
Department of Physiotherapy, School of Health Sciences, Chhatrapati Shahu Ji Maharaj University Kanpur
Kanpur Nagar
UTTAR PRADESH
208024
India |
| Phone |
8299754806 |
| Fax |
|
| Email |
vkalpana604@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aakanksha Bajpai PT |
| Designation |
Assistant Professor |
| Affiliation |
Chhatrapati Shahu Ji Maharaj University Kanpur |
| Address |
Room number 127, Department of Physiotherapy, School of Health Sciences, Chhatrapati Shahu Ji Maharaj University Kanpur
Kanpur Nagar
UTTAR PRADESH
208024
India |
| Phone |
7524853949 |
| Fax |
|
| Email |
akankshabajpai@csjmu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Kalpana Verma |
| Designation |
Student |
| Affiliation |
Chhatrapati Shahu Ji Maharaj University Kanpur |
| Address |
Department of Physiotherapy, School of Health Sciences, Chhatrapati Shahu Ji Maharaj University Kanpur
Kanpur Nagar
UTTAR PRADESH
208024
India |
| Phone |
8299754806 |
| Fax |
|
| Email |
vkalpana604@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, School of Health Sciences, Chhatrapati Shahu Ji Maharaj University Kanpur, Uttar Pradesh, India, 208024. |
|
|
Primary Sponsor
|
| Name |
Kalpana Verma |
| Address |
Department of Physiotherapy, School of Health Sciences, Chhatrapati Shahu Ji Maharaj University Kanpur, Uttar Pradesh, India, 208024. |
| Type of Sponsor |
Other [Self Finance] |
|
|
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 Aakanksha Bajpai PT |
Chhatrapati Shahu Ji Maharaj University, Kanpur |
Room 127, Department of Physiotherapy, School of Health Sciences, Chhatrapati Shahu Ji Maharaj University, Kanpur, Uttar Pradesh, India, Pin Code-208024.
Kanpur Nagar
UTTAR PRADESH |
7524853949
akankshabajpai@csjmu.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Chhatrapati Shahu JI Maharaj University Kanpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Middle Aged Adults |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
Middle- Aged Adults (between 40 to 59 years)
Both Men and Women
Stable Vitals
Non – smokers
Normal BMI (18.5 – 24.9 kg/m2)
|
|
| ExclusionCriteria |
| Details |
Patient with Comorbidities (Diabetes Mellitus, Hypertension, Thyroid etc.)
Pregnancy
Anyone who has been involved in any recreational activities or sports in the last 6 months.
Any documented medical history of Cardio pulmonary disorders, Musculoskeletal problem, Neurological problem, Hearing or other problem.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Physical Activity-International Physical Activity Questionnaire - Short Form
Pulmonary Function- Spirometry
Quality of Life- Short Form-36
|
One Time
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Sleep, Mental Health |
One Time |
|
|
Target Sample Size
|
Total Sample Size="238"
Sample Size from India="238"
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)
|
06/10/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response (Others) -
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 20-09-2024 and end date provided 20-09-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The purpose is to evaluate the correlation of
changes in physical activity levels on
pulmonary function and quality of life among middle aged adults.OBJECTIVE:-
To compare changes in
physical activity levels
among middle-aged adults
sedentary to active
or active to more
active). Evaluate pulmonary
function parameters and quality-of-life domains using standardized assessments. Analyze the
correlation between physical
activity changes on
pulmonary function and
quality of life.
METHODOLOGY:-
1. Study design :-
Cross Sectional
Study
2. Study Population:-
Middle-Aged (40-59 years) Adults
3. Sampling Method :-
Purposive Sampling
|