| CTRI Number |
CTRI/2025/08/092332 [Registered on: 04/08/2025] Trial Registered Prospectively |
| Last Modified On: |
04/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study on the Link Between Breathing problems and urine leakage in people with lung disease |
|
Scientific Title of Study
|
ASSOCIATION BETWEEN LUNG FUNCTION PEAK EXPIRATORY FLOW RATE PEFR AND URINARY INCONTINENCE IN INDIVIDUALS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE COPD
|
| Trial Acronym |
Lung function Incontinence Pefr in COPD |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ranjana Manjunatha Hegde |
| Designation |
Postgraduate Student |
| Affiliation |
SDM College Of Physiotherapy Dharwad |
| Address |
SDM College Of Physiotherapy Shri Dharmasthala Manjunatheshwara
University Dharwad 580009
Karnataka
Dharwad
KARNATAKA
580009
India |
| Phone |
9481572387 |
| Fax |
|
| Email |
hegderanjanamanjunath@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shubha Akadas |
| Designation |
Assistant Professor |
| Affiliation |
SDM College Of Physiotherapy Dharwad |
| Address |
SDM College Of Physiotherapy Shri Dharmasthala Manjunatheshwara
University Dharwad 580009
Karnataka
Dharwad
KARNATAKA
580009
India |
| Phone |
9739488007 |
| Fax |
|
| Email |
shubhaakadas@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shubha Akadas |
| Designation |
Assistant Professor |
| Affiliation |
SDM College Of Physiotherapy Dharwad |
| Address |
SDM College Of Physiotherapy Shri Dharmasthala Manjunatheshwara
University Dharwad 580009
Karnataka
Dharwad
KARNATAKA
580009
India |
| Phone |
9739488007 |
| Fax |
|
| Email |
shubhaakadas@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM College Of Medical Sciences And Hospital Dharwad |
|
|
Primary Sponsor
|
| Name |
Ranjana Manjunatha Hegde |
| Address |
SDM College of Physiotherapy Shri Dharmasthala Manjunatheshwara
University Dharwad 580009
Karnataka |
| Type of Sponsor |
Other [] |
|
|
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 |
| Ranjana Manjunatha Hegde |
SDM College Of Medical Sciences And Hospital Dharwad |
COPD Diagnosed Patients in Pulmonology OPD And IPD
SDM College Of Medical Sciences And Hospital Manjushree Nagar Sattur Dharwad 580009
Dharwad
KARNATAKA |
9481572387
hegderanjanamanjunath@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 |
| Patients |
(1) ICD-10 Condition: J96-J99||Other diseases of the respiratory system, (2) ICD-10 Condition: N30-N39||Other diseases of the urinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1 Individuals willing to participate
2 Individuals diagnosed with COPD by
pulmonologist and aged in between 40 75 yrs
3 Individuals of all genders
4 Individuals who can read or write and communicate in English hindi or kannada
5 COPD individuals with co morbid conditions under control like Hypertension and diabetes
|
|
| ExclusionCriteria |
| Details |
1 Patients who are on supplemental oxygen or artificial ventilation
2 Patients unable to follow commands
3 Individuals with recent MI or unstable angina
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
ICIQ UI SF questionnaire
FEV1 TO FVC ratio
PEFR AND MVV
|
First day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
MMRC Breathleness grade
Leicester Cough Questionnaire |
First day |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
02/10/2025 |
| 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="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- 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 - Proposals should be directed to [hegderanjanamanjunath@gmail.com].
- For how long will this data be available start date provided 14-07-2027 and end date provided 14-07-2030?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Participants diagnosed with COPD by pulmonologist will
be selected based on inclusion and exclusion criteria Individuals who are
willing to participate an informed consent form will be given and included in
the study These participants will be
assessed for Urinary Incontinence using ICIQ-UI SF International
Consultation on Incontinennce Questionnaire Urinary Incontinence Short Form and Pulmonary function tests FEV1 to FVC ratio peak expiratory flow rate PEFR and MVV
will be conducted to evaluate lung function Cough severity will
be assessed by the Leicester Cough Questionnaire and breathlessness will be
assessed by the modified Medical Research Council mMRC grading scale
The PFT FEV1 to FVC ratio PEFR and MVV results of participants with both COPD and UI will then be
compared to those of participants with COPD alone |