| CTRI Number |
CTRI/2018/06/014443 [Registered on: 07/06/2018] Trial Registered Prospectively |
| Last Modified On: |
30/05/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Combine effect of two breathing exercise in
Abdominal surgery patients |
|
Scientific Title of Study
|
Added effect of deep breathing and diaphragmatic breathing exercise in upper abdominal surgery patients - A Randomised clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nirali Mistry |
| Designation |
Post Graduate |
| Affiliation |
Nitte Deemed to be University |
| Address |
K. S. Hegde Hospital,
Deralakatte,
Mangalore.
Derlakatte, Mangalore, 575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8861138812 |
| Fax |
|
| Email |
mistrynirali2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Saumya Srivastava |
| Designation |
Associate professor |
| Affiliation |
NITTE Deemed to be UNIVERSITY |
| Address |
K. S. Hegde Hospital,
Deralakatte,
Mangalore.
DERLAKATTE, MANGALORE, 575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9740244077 |
| Fax |
|
| Email |
saumyasri2000@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Nirali Mistry |
| Designation |
Post Graduate |
| Affiliation |
Nitte Deemed to be University |
| Address |
K. S. Hegde Hospital,
Deralakatte,
Mangalore.
Derlakatte, Mangalore, 575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8861138812 |
| Fax |
|
| Email |
mistrynirali2@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nitte(Deemed to be University), Deralakatte, Mangalore 575018, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
NITTE Institute of Physiotherapy |
| Address |
Deralakatte, Mangalore - 575018, Karnataka. |
| Type of Sponsor |
Private 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 |
| Nirali Mistry |
K. S. Hegde Hospital |
Department of surgery, general ward, second floor, Deralakatte, Mangalore- 575018.
Dakshina Kannada
KARNATAKA |
8861138812
mistrynirali2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee, NITTE INSTITUTE OF PHYSIOTHERAPY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
patient undergone upper abdominal surgery with post operative day 1, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intervention (Group A) |
Diaphragmatic breathing exercises plus Early Mobilization Excersises |
| Intervention |
Intervention (Group B) |
Deep Breathing Exercises plus Early Mobilization Exercises |
| Intervention |
Intervention (Group C) |
Diaphragmatic Breathing Exercises, Deep breathing Exercises and Early Mobilization Exercises |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Any upper abdominal surgery
Visual analogue pain scale score < 5
No previous history of cardiac and pulmonary complications
Non-obese individual (body mass index < 27 kg/m2)
Patients willing to participate. |
|
| ExclusionCriteria |
| Details |
Patients with hemodynamic instability
Patient who required ICU care for more than 48 hours
It excluded patients undergoing lower abdominal surgeries
Patients with cognitive impairments and uncooperative patients or patients unable
to understand
Patients who had undergone laparoscopic obstetrics and gynecological surgery.
Patients with postoperative complications requiring mechanical ventilation |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pulmonary Function Test
FEV1 AND FVC |
Post operative day 1
Post operative day 4
Post operative day 7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Chest Expansion Measurement
|
Post operative day 1
Post operative day 4
Post operative day 7 |
Activity Measure for Post-Acute Care (AM-PAC) “6-Clicks†Inpatient Daily
Activity and Basic Mobility Short Forms |
Post operative day 1
Post operative day 4
Post operative day 7 |
|
|
Target Sample Size
|
Total Sample Size="69"
Sample Size from India="69"
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)
|
11/06/2018 |
| 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="11"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The present study has been undertaken inorder to evaluate the added effect of diaphragmatic breathing and deep breathing exercise in upper abdominal surgery patients. The patient who under went upper abdominal surgery will be recruited randomly using randomisation method and will be given treatment according to their respective groups. Group A will receive diaphragmatic breathing exercise along with conservative treatment, Group B will receive deep breathing exercise along with conservative treatment and Group C will receive diaphragmatic breathing and deep breathing exercise along with the conservative treatment. The treatment will be given fro 7days from post operative day 1. each day 4-6 cycles of breathing exercise for 8 hours in a day. The outcome measures will be taken on the day 1 of the treatment , day 4 and day 7 by the blinded assessor. Primary outcome measure will be pulmonary function test and secondary will be chest expanion using inch tape method and Activity Measure for Post-Acute Care (AM-PAC) “6-Clicks†Inpatient Daily
Activity and Basic Mobility Short Forms.
|