| CTRI Number |
CTRI/2024/05/067454 [Registered on: 15/05/2024] Trial Registered Prospectively |
| Last Modified On: |
13/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
assessment of Carryover effect of incentive spirometry on respiratory parameters in chronic obstructive pulmonary disease patients. |
|
Scientific Title of Study
|
Carryover effect of incentive spirometry on respiratory parameters in chronic obstructive pulmonary disease patients. A pilot study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aditi L Soman |
| Designation |
Assistant Professor |
| Affiliation |
Deccan Education Society’s Brijlal Jindal College of Physiotherapy |
| Address |
DEPARTMENT OF CARDIOVASCULAR & RESPIRATORY PHYSIOTHERAPY
FERGUSSON COLLEGE CAMPUS
SHIVAJINAGAR
Pune
MAHARASHTRA
411004
India |
| Phone |
918788123192 |
| Fax |
|
| Email |
aditi.soman@despune.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aditi L Soman |
| Designation |
Assistant Professor |
| Affiliation |
Deccan Education Society’s Brijlal Jindal College of Physiotherapy |
| Address |
DEPARTMENT OF CARDIOVASCULAR & RESPIRATORY PHYSIOTHERAPY
FERGUSSON COLLEGE CAMPUS
SHIVAJINAGAR
MAHARASHTRA
411004
India |
| Phone |
918788123192 |
| Fax |
|
| Email |
aditi.soman@despune.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhavika Dugarwal |
| Designation |
Post Graduate student |
| Affiliation |
Deccan Education Society’s Brijlal Jindal College of Physiotherapy |
| Address |
DEPARTMENT OF CARDIOVASCULAR & RESPIRATORY PHYSIOTHERAPY
FERGUSSON COLLEGE CAMPUS
SHIVAJINAGAR
Pune
MAHARASHTRA
411004
India |
| Phone |
918975306969 |
| Fax |
|
| Email |
bhavikadungarwalwani@gmail.com |
|
|
Source of Monetary or Material Support
|
| NIL
Self Funded
Data will be collected from COPD patients visiting physiotherapy OPD of Deccan Education Society Brijlal Jindal College of Physiotherapy Pune Maharashtra India
And pulmonology OPD in and around Pune.
Permission from authority of such institutions is yet to be obtained.
Permission will be taken after CTRI registration |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
self funded
The study procedure needs travel expenses, stationery like pen papers, stopwatch, measuring tape. patients own
Incentive spirometer will be used.
This all expenses will be born by PG STUDENT and Guide |
| Type of Sponsor |
Other [Data willbe collected from COPD patients visiting pulmonilogists OPD] |
|
|
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 Bhavika Dundgarwal |
Deccan Education Societys Brijlal Jindal College Of Physiotherapy OPD |
Department of cardiovascular and Respiratory Physiotherapy, ground floor, Health science Building, Fergusson college
campus, Shivaji Nagar
Pune
MAHARASHTRA |
918788123192
bhavikadungarwalwani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DECCAN EDUCATION SOCIETYS BRIJLAL JINDAL COLLEGE OF PHYSIOTHERAPY ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J42||Unspecified chronic bronchitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
10 repetitions of incentive spirometer will be performed for approximately 5 min |
respiratory parameters will be assessed after a session of incentive spirometer for 3 times; immediately after incentive spirometer,10 min and 20 min after performing the Incentive spirometer |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
nil |
|
| ExclusionCriteria |
| Details |
Subjects with other cardio-pulmonary, hepatic, Renal comorbidities Subjects who are not able to communicate.
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Respiratory rate (RR)
Saturation of oxygen (SPO2)
Chest expansion (CE)
Single breath count (SBC)
Peak expiratory flow rate (PEFR)
|
3 times
espiratory parameters will be assessed after a session of incentive spirometer for 3 times; immediately after incentive spirometer,10 min and 20 min after performing the Incentive spirometer |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="14"
Sample Size from India="14"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/06/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="15" |
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
|
|
Chronic obstructive pulmonary disease (COPD)
is a chronic inflammatory lung disease that causes obstructed airflow from
the lungs. COPD is a heterogeneous, common, preventable, and
treatable disease that is characterized by persistent respiratory symptoms
and airflow limitation that are due to airway and/or alveolar abnormalities
usually caused by significant exposure to noxious particles or gases(6).
Incentive
Spirometry can be used easily and is also a safe and cost-effective method. With
the aim of encouraging the patient to breathe deeply and create maximum
dilatation in the bronchi to improve lung volume and to improve oxygen
delivery and proper ventilation through visual feedback, thought to maximize
accuracy of breathing technique and motivation(7).
Hence
the need focuses on the duration of the effects due to incentive spirometry,
as it will give an idea of accurate dosage in COPD patients.
Previous
studies have shown the effects of the use of incentive spirometry in COPD
patients, but there have been few studies which highlighted the duration of
effect of incentive spirometry on respiratory parameters after a single
session.
|
Thus, this study
focuses on the length of duration of effectiveness of incentive spirometry in
COPD patients. |