| CTRI Number |
CTRI/2023/01/048698 [Registered on: 03/01/2023] Trial Registered Prospectively |
| Last Modified On: |
06/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Comparison between effect of two breathing exercises on upper abdominal surgery |
|
Scientific Title of Study
|
Comparison between effect of Buteyko breathing technique and Stacked breathing technique on pulmonary function and quality of life in patients undergone upper abdominal surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ruchita Rao Chilkapurwar |
| Designation |
MPT First year Cardiovascular and Respiratory physiotherapy |
| Affiliation |
DVVPFs college of physiotherapy |
| Address |
Department of cardiovascular and respiratory physiotherapy Block 1 Basement DVVPFs college of physiotherapy Oppo Govt Milk Dairy MIDC Ahmednagar
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
9021103515 |
| Fax |
|
| Email |
chilkapurwar24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhijit D Diwate |
| Designation |
HOD Cardiovascular and Respiratory Physiotherapy |
| Affiliation |
DVVPFs college of physiotherapy |
| Address |
Department of cardiovascular and respiratory physiotherapy Block 1 Basement DVVPFs college of physiotherapy Oppo Govt Milk Dairy MIDC Ahmednagar
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
08554990222 |
| Fax |
|
| Email |
abhijitdiwate@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ruchita Rao Chilkapurwar |
| Designation |
MPT First year Cardiovascular and Respiratory physiotherapy |
| Affiliation |
DVVPFs college of physiotherapy |
| Address |
Department of cardiovascular and respiratory physiotherapy Block 1 Basement DVVPFs college of physiotherapy Oppo Govt Milk Dairy MIDC Ahmednagar
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
09021103515 |
| Fax |
|
| Email |
chilkapurwar24@gmail.com |
|
|
Source of Monetary or Material Support
|
| DVVPFs College of Physiotherapy opp Govt milk dairy MIDC Ahmednagar |
|
|
Primary Sponsor
|
| Name |
DVVPFs College of Physiotherapy |
| Address |
DVVPFs college of physiotherapy Oppo Govt Milk Dairy MIDC Ahmednagar |
| 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 |
| Dr Ruchita Rao Chilkapurwar |
DVVPFs college and hospital |
Department of cardiovascular and respiratory physiotherapy Block 1 Basement DVVPFs college of physiotherapy Oppo Govt Milk Dairy MIDC Ahmednagar
Ahmadnagar
MAHARASHTRA |
09021103515
chilkapurwar24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DVVPFs COPT Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K315||Obstruction of duodenum, (2) ICD-10 Condition: K90-K95||Other diseases of the digestive system, (3) ICD-10 Condition: K811||Chronic cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Buteyko Breathing |
it is a type of breathing exercise, which include normal breathing, control pause and relaxed reduced volume breathing
It will be given for 5 days from day of recruitment for 2 times a day |
| Intervention |
Stacked breathing |
It is an exercise which helps to improve and maintain the size of breath you take and can be used regularly to clear mucus.
It will be given for 5 days from the day of recruitment for 2 times aday |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Individuals who underwent upper abdominal surgery |
|
| ExclusionCriteria |
| Details |
1. Subject already diagnosed with any neuromuscular diseases
2. Individuals with severe musculoskeletal dysfunction
3. Individuals with diagnosed cardiac diseases
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pulmonary function Peak expiratory flow rate quality of life |
Pre intervention i.e Baseline, PEFR each day of intervention and post intervention on 5th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Hight
weight
|
pre, post intervention |
|
|
Target Sample Size
|
Total Sample Size="16"
Sample Size from India="16"
Final Enrollment numbers achieved (Total)= "19"
Final Enrollment numbers achieved (India)="19" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/01/2023 |
| Date of Study Completion (India) |
04/07/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
04/07/2023 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is to see the effectiveness of the Buteyko breathing and Stack breathing technique on quality of life and pulmonary function in upper abdominal surgery patients. 16 patients with upper abdominal surgery will be recruited based on inclusion and exclusion criteria. There will be two groups: the first group will receive Buteyko breathing and the second group will receive the stack breathing technique. The whole intervention will be of 5 days and the outcome will be assessed at the baseline and 5th day of the intervention. And data will be analyzed statistically. |