| CTRI Number |
CTRI/2025/03/083166 [Registered on: 24/03/2025] Trial Registered Prospectively |
| Last Modified On: |
22/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
effect of breathing exercises in patients with upper abdominal surgery. |
|
Scientific Title of Study
|
To compare effects of stack breathing versus diaphragmatic breathing on chest expansion and vital parameters in patients with upper abdominal surgeries: An experimental 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 |
Elsa Fernandes |
| Designation |
PG Student |
| Affiliation |
College of Physiotherapy Sumandeep Vidyapeeth Deemed to be University |
| Address |
Ground floor
College of Physiotherapy Sumandeep Vidyapeeth Deemed to be University
Piparia
Waghodia
Vadodara
391760
GUJARAT
India
Vadodara
GUJARAT
391760
India |
| Phone |
9558803869 |
| Fax |
|
| Email |
elsathomas150301@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tejas Chokshi |
| Designation |
Associate Professor |
| Affiliation |
College of Physiotherapy Sumandeep Vidyapeeth Deemed to be University |
| Address |
Ground floor
College of Physiotherapy Sumandeep Vidyapeeth Deemed to be University
Piparia
Waghodia
Vadodara
391760
GUJARAT
India
Vadodara
GUJARAT
391760
India |
| Phone |
9909557689 |
| Fax |
|
| Email |
svdu.administrator@sumandeepvidyapeethdu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tejas Chokshi |
| Designation |
Associate Professor |
| Affiliation |
College of Physiotherapy Sumandeep Vidyapeeth Deemed to be University |
| Address |
Ground floor
College of Physiotherapy Sumandeep Vidyapeeth Deemed to be University
Piparia
Waghodia
Vadodara
391760
GUJARAT
India
Vadodara
GUJARAT
391760
India |
| Phone |
9909557689 |
| Fax |
|
| Email |
svdu.administrator@sumandeepvidyapeethdu.edu.in |
|
|
Source of Monetary or Material Support
|
| Ground floor
College of Physiotherapy Sumandeep Vidyapeeth Deemed to be University
Piparia
Waghodia
Vadodara
391760
GUJARAT
India |
|
|
Primary Sponsor
|
| Name |
Elsa Fernandes |
| Address |
College of Physiotherapy Sumandeep Vidyapeth Deemed to be
Unviersity Piparia,Waghodia,Vadodara-391760
GUJARAT
India |
| Type of Sponsor |
Other [Self Funded] |
|
|
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 |
| Elsa Fernandes |
Dhiraj General Hospital |
fourth floor
general surgery ward
Diharj General Hospital
Sumandeep Vidyapeeth Deemed to be University
Piparia
Waghodia
Vadodara
391760
Vadodara
GUJARAT |
9558803869
elsathomas150301@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidyapeeth Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K20-K31||Diseases of esophagus, stomach and duodenum, (2) ICD-10 Condition: K70-K77||Diseases of liver, (3) ICD-10 Condition: K80-K87||Disorders of gallbladder, biliary tract and pancreas, (4) ICD-10 Condition: K40-K46||Hernia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Diaphragmatic breathing and Conventional Physiotherapy |
diaphragmatic breathing is given in semifowler position and then patient is commanded to place your hand on the rectus abdominis just below the anterior coastal margin. Ask the patient to breathe in slowly and deeply through the nose. Have the patient keep
the shoulders relaxed and upper chest quiet, allowing the abdomen to rise slightly.
Then tell the patient to relax and exhale slowly through the mouth.Have the patient practice this 3-4 times and then rest. Do not allow the patient to hyperventilate.
Have the patient practice this 3-4 times and then rest. Do not allow the patient to
hyperventilate.
and in conventional Physiotherapy splinted coughing is given from POD1 Till the time of discharge, mobilisation (sit on bed edge, walk 5m, 10m, 15m and ROM of upper and lower limb) is given from POD 1 till the time of Discharge for 2 times in a day for 1 week. |
| Intervention |
Stack breathing and conventional physiotherapy |
Stack breathing will be given in semifowler or long sitting position and then the patient is commanded to breath out fully and then breath in fully and hold the breath for 3-5 seconds and then take another breath in over the previous one and repeat it for 2-5 times and then slowly breath out.
repeat it for 5 times and keep rest of 30 seconds in between them
and in conventional Physiotherapy splinted coughing is given from POD1 Till the time of discharge, mobilisation (sit on bed edge, walk 5m, 10m, 15m and ROM of upper and lower limb) is given from POD 1 till the time of Discharge for 2 times in a day for 1 week. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with open upper abdominal surgery with incision on upper Quadrant (Right
hypochondriac, epigastric, left hypochondriac) of Abdomen (Kocher’s, transverse and
paramedian).
2. Both genders will be taken
3. Age group 18 to 60 years. |
|
| ExclusionCriteria |
| Details |
1. Existing pulmonary complication
2. Existing musculoskeletal and neurological conditions which affects pulmonary
functions
3. Patient who requires prolong mechanical ventilatory support or tracheostomy after
surgery.
4. Hemodynamically unstable patient. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Chest Expansion |
chest expansion will be taken with inch tape method pre and post intervention on post operative day 1,3,5 and at the time of discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
vital parameters(heart rate respiratory rate
blood pressure
SPO2) |
vital parameters(heart rate respiratory rate
blood pressure
SPO2) heart rate & SPO2 will be taken with pulse oximeter & respiratory rate will be taken with observatory method & blood pressure will be taken with Sphygmomanometer pre & post intervention on post operative day 1
3
5 & at the time of discharge |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/04/2025 |
| Date of Study Completion (India) |
17/01/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
In this study participants will be allocated into two groups. control group will receive diaphragmatic breathing and conventional physiotherapy for 2 times a day till the time of discharge and experimental group will receive stack breathing and conventional physiotherapy for 2 times a day till the time of discharge. the patients will be assessed for chest expansion using inch tape method and vital parameters (Heart rate, Respiratory Rate, Blood Pressure, SPO2) heart rate and SPO2 using pulse oximeter, Respiratory rate using observatory method and Blood Pressure using Sphygmomanometer. this will be assessed at pod 1,3,5 and at the time of discharge pre and post intervention. |