| CTRI Number |
CTRI/2026/02/103359 [Registered on: 09/02/2026] Trial Registered Prospectively |
| Last Modified On: |
07/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Breathing Exercise to Improve Lung Function, Diaphragm Movement, and Pain After Abdominal Surgery |
|
Scientific Title of Study
|
Effect of Acapella versus Incentive Spirometry on Diaphragmatic Excursion, Pulmonary Function Parameter and Pain Intensity in Patients Undergoing Abdominal Surgery:A Randomized Control Trial |
| 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 Ganesh BR |
| Designation |
Professor and HOD, Department of Cardiovascular and Pulmonary Physiotherapy |
| Affiliation |
KAHER Institute Of Physiotherapy |
| Address |
KLES Dr. Prabhakar Kore Hospital and MRC, Advanced Physiotherapy Center Cardiovascular and Pulmonary Physiotherapy Department Room No.6, Nehru Nagar, Belagavi,Karnataka-590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9844857581 |
| Fax |
|
| Email |
drganeshnssofficer@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ganesh BR |
| Designation |
Professor and HOD, Department of Cardiovascular and Pulmonary Physiotherapy |
| Affiliation |
KAHER Institute Of Physiotherapy |
| Address |
KLES Dr. Prabhakar Kore Hospital and MRC, Advanced Physiotherapy Center Cardiovascular and Pulmonary Physiotherapy Department Room No.6, Nehru Nagar, Belagavi,Karnataka-590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9844857581 |
| Fax |
|
| Email |
drganeshnssofficer@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Tejashwini Birajdar Birajdar |
| Designation |
Postgraduate student,Cardiovascular and Pulmonary Physiotherapy |
| Affiliation |
KAHER Institute Of Physiotherapy |
| Address |
KLES Dr. Prabhakar Kore Hospital and MRC, Advanced Physiotherapy Center Cardiovascular and Pulmonary Physiotherapy Department Room No.6, Nehru Nagar, Belagavi,Karnataka-590010
Belgaum
KARNATAKA
590010
India |
| Phone |
09686151072 |
| Fax |
|
| Email |
tejashwini.b.13@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tejashwini Birajdar
KLES Dr Prabhakar Kore Hospital and MRC,Advanced Physiotherapy Center Cardiovascular and Pulmonary Physiotherapy Department Room No. 6, Nehru Nagar, Belgavi, Karnataka- 590010 |
|
|
Primary Sponsor
|
| Name |
Tejashwini Birajdar |
| Address |
KAHER Institute of Physiotherapy, Nehru Nagra, Belagavi,Karnataka-590010 |
| Type of Sponsor |
Other [Self-Sponsored] |
|
|
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 Ganesh BR |
KLES Dr. Prabhakar Kore Hospital and MRC |
KLES Dr. Prabhakar Kore Hospital and MRC, Advanced Physiotherapy Center Cardiovascular and Pulmonary Physiotherapy Department Room No.6, Nehru Nagar, Belagavi,Karnataka-590010
Belgaum
KARNATAKA |
9844857581
drganeshnssofficer@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and ethics committee KAHER Institute of physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K911||Postgastric surgery syndromes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A: Acapella |
Patients will be trained to perform 10-15 breaths/sessions, 2 sets/day using Acapella. Expiration will be done through the device with moderate resistance to produce oscillatory positive expiratory pressure. |
| Comparator Agent |
Group B: Incentive Spirometer |
Patients will perform 10 sustained maximal inspiration/session, 2 sets/day using the IS device, with breath-hold of 3-5 seconds at full inspiration |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects of both gender between the age of 30 to 60 years under going elective abdominal surgery |
|
| ExclusionCriteria |
| Details |
Pre-existing respiratory condition. Prolonged mechanical ventilation. Emergency abdominal surgeries. Patients with active respiratory infection. Neuromuscular disorders. Cardiac instability |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Diaphragmatic Excursion |
Day1 and Day 5 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Peak Expiratory Flow Rate,Oxygen Saturation,and Pain Intensity |
Day1 and Day 5 |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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)
|
20/02/2026 |
| 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="6"
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 - NO
|
|
Brief Summary
|
This randomized control trial study comparesthe effect of acapella versus incentive spirometry in patients under going abdominal surgery . The aims to evaluate their impact on diaphramatic excursion,pulmonary function parameter, and pain intensityin 56 subjects aged between 30 to 60 years will be randomly allocated into 2 groups. Intervention will be given along with conventional post operative physiotherapy for 5 days. Outcome measureswill be measured by using USG, Spo2,VAS scale . The study seeks to provide evidence based guidance for improving postoperative pulmonary recovery |