| CTRI Number |
CTRI/2024/09/073881 [Registered on: 13/09/2024] Trial Registered Prospectively |
| Last Modified On: |
11/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
relation between knowledge of COPD,HRQL,
level of physical activity and
dyspnea score in patients with
obstructive pulmonary diseases |
|
Scientific Title of Study
|
Correlation between knowledge of COPD, health related quality of life, level of physical activity and dyspnea score in patients with COPD |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sushma |
| Designation |
pg student |
| Affiliation |
Pt. B. D. Sharma PGIMS Rohtak |
| Address |
Department of physiotherapy ,E-block ,College of physiotherapy
Pt. B. D. Sharma PGIMS Rohtak
124001
HARYANA
Department of physiotherapy ,E-block ,
Pt. B. D. Sharma PGIMS Rohtak
124001
HARYANA
India
Rohtak
HARYANA
124001
India |
| Phone |
|
| Fax |
|
| Email |
jangidsushma1234@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gitanjali Sikka |
| Designation |
Assistant professor |
| Affiliation |
Pt. B. D. Sharma PGIMS Rohtak |
| Address |
Department of physiotherapy ,E-block , College of physiotherapy
Pt. B. D. Sharma PGIMS Rohtak
124001
HARYANA
Department of physiotherapy ,E-block ,
Pt. B. D. Sharma PGIMS Rohtak
124001
HARYANA
HARYANA
124001
India |
| Phone |
7015208384 |
| Fax |
|
| Email |
gsikka27@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gitanjali Sikka |
| Designation |
Assistant professor |
| Affiliation |
Pt. B. D. Sharma PGIMS Rohtak |
| Address |
Department of physiotherapy ,E-block , College of physiotherapy
Pt. B. D. Sharma PGIMS Rohtak
124001
HARYANA
Department of physiotherapy ,E-block ,
Pt. B. D. Sharma PGIMS Rohtak
124001
HARYANA
Rohtak
HARYANA
124001
India |
| Phone |
7027192620 |
| Fax |
|
| Email |
gsikka27@gmail.com |
|
|
Source of Monetary or Material Support
|
| department of pulmonary critical care medicine , Pt. B. D. Sharma PGIMS Rohtak, 124001 |
|
|
Primary Sponsor
|
| Name |
Pt B D Sharma PGIMS Rohtak |
| Address |
college of physiotherapy , E-block, Pt. B. D. Sharma PGIMS Rohtak
214001
HARYANA |
| Type of Sponsor |
Government medical college |
|
|
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 Gitanjali Sikka |
Pt. B. D. Sharma PGIMS Rohtak |
Department of physiotherapy ,E-block , College of physiotherapy , Pt. B. D. Sharma PGIMS Rohtak
124001
HARYANA
Rohtak
HARYANA |
7027192620
gsikka27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee Pt. B. D. Sharma PGIMS Rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J00-J99||Diseases of the respiratory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
patients diagnosed with mild to severe COPD as per Global initiative for chronic obstructive lung diseases gold criteria referred by pulmonologist and physician ,age more than 40 years |
|
| ExclusionCriteria |
| Details |
Patients who are not co-operative, Patients diagnosed with major psychiatric disorders or severe cognitive impairments who could not complete questionnaire. Patients with confusion secondary to exacerbation of COPD.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
BCKQ (Bristol COPD knowledge questionnaire)
SGRQ (St. George respiratory questionnaire)
IPAQ (International Physical Activity Questionnaire)
|
at baseline (visit 1)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
BCKQ (Bristol COPD knowledge questionnaire)
SGRQ (St. George respiratory questionnaire)
IPAQ (International Physical Activity Questionnaire)
Dyspnea score
|
at baseline (visit 1) |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
30/09/2024 |
| 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="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
|
to assess the correlation between knowledge of COPD, health related quality of life, level of physical activity and dyspnea score in patients with COPD.To the best of our knowledge there has been no
study done till date on correlation between COPD knowledge, health related
quality of life, physical activity level and dyspnea score in patients with
COPD in Haryana, India. Understanding the relationship between these variables
can lead to better healthcare strategies and interventions for COPD patients.
By identifying factors that influence HRQoL, physical activity levels, and
dyspnea in COPD patients, healthcare professionals can tailor treatment plans
to address specific needs and improve overall patient outcomes. |