| CTRI Number |
CTRI/2024/03/063688 [Registered on: 06/03/2024] Trial Registered Prospectively |
| Last Modified On: |
27/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Instant Effects of Buteyko Breathing versus Breath Stacking Technique on Physiological specifications in Patients with Minimally Invasive Abdominal Surgeries |
|
Scientific Title of Study
|
Immediate Effect of Buteyko Breathing versus Breath Stacking Technique on Physiological Parameters among Patient with Laparoscopic Abdominal Surgeries: Two-group pretest - posttest study design |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deeksha Mehta |
| Designation |
BPT Student |
| Affiliation |
Maharishi Markandeshwar Medical College and Hospital |
| Address |
Department of Physiotherapy, Physiotherapy OPD, Room no. 510, Maharishi Markandeshwar Medical College and Hospital Kumarhatti, Solan
Solan
HIMACHAL PRADESH
173229
India |
| Phone |
7876415175 |
| Fax |
|
| Email |
deekshamehta2005@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Geetanjali Kaul |
| Designation |
Assistant Professor |
| Affiliation |
Maharishi Markandeshwar Medical College and Hospital |
| Address |
Department of Physiotherapy, Physiotherapy OPD, Room no. 510, Maharishi Markandeshwar Medical College and Hospital Kumarhatti, Solan
Solan
HIMACHAL PRADESH
173229
India |
| Phone |
7018518005 |
| Fax |
|
| Email |
drgeetanjalikaul@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sarita Khadayat |
| Designation |
Assistant Professor |
| Affiliation |
Maharishi Markandeshwar Medical College and Hospital |
| Address |
Department of Physiotherapy, Physiotherapy OPD, Room no. 510, Maharishi Markandeshwar Medical College and Hospital Kumarhatti, Solan
Solan
HIMACHAL PRADESH
173229
India |
| Phone |
8979997426 |
| Fax |
|
| Email |
khdytsarita@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, Physiotherapy OPD, Room no. 510, Maharishi Markandeshwar Medical College and Hospital Kumarhatti, Solan |
|
|
Primary Sponsor
|
| Name |
Deeksha Mehta |
| Address |
Department of Physiotherapy, Physiotherapy OPD, Room no. 510, Maharishi Markandeshwar Medical College and Hospital Kumarhatti, Solan |
| Type of Sponsor |
Other [Self] |
|
|
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 Geetanjali Kaul |
Department of Surgery, Maharishi Markandeshwar Medical College and Hospital |
Room no. A-509, A-513, Maharishi Markandeshwar Medical College and Hospital Kumarhatti, Solan
Solan
HIMACHAL PRADESH |
7018518005
drgeetanjalikaul@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Maharishi Markandeshwar Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Breath Stacking Technique |
For Breath stacking technique patient will be in semi fowler position and then the patient will be asked to take three deep breaths in a slower pace by placing one hand on abdomen. Patient will be asked to take 3-4 consecutive breaths one after another and hold them as long as they can – up to their maximum capacity for 10 seconds and then slowly exhale through pursed lips.
Total duration of the treatment will be one day. |
| Comparator Agent |
Buteyko Breathing Technique |
In Buteyko breathing technique patient will be in semi fowler position Then the patient will be asked to place one hand on the abdomen and inhale and exhale slowly and hold. Ask the patient to plug the nose using the index finger and thumb to prevent the air entering into the lungs. Breath holding will performed till the patient will have an urge to breathe again. Total duration of the treatment will be one day. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with laproscopic abdominal surgeries
Patients on Post operative day – 1 (within 24 - 36 hours)
Normal subjects as per Asian BMI classification
GCS- 13 and above
Non-smoker subjects |
|
| ExclusionCriteria |
| Details |
Patients with post-operative period more than 36 hours
Patients with respiratory problems such as
Asthma, TB, Pneumonia
Patients on oxygen support
Patients with any previous surgeries
Patients with haemodynamic repercussion
Un-cooperative patients
Any type of chest deformity
Any type of acute chest injuries |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pulse oximeter
Sphygmomanometer
|
2 times measurements
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain score |
2 time measurement |
|
|
Target Sample Size
|
Total Sample Size="122"
Sample Size from India="122"
Final Enrollment numbers achieved (Total)= "130"
Final Enrollment numbers achieved (India)="130" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/03/2024 |
| Date of Study Completion (India) |
14/05/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Buteyko breathing and breath stacking techniques are the new techniques for the clinical implementation in patients with abdominal surgeries. Buteyko breathing technique is used in different conditions like asthma, hypertension etc and found to be effective on cardiorespiratory and physiological parameters. On the other hand Breath Stacking technique is used in different conditions as well as in patients with abdominal surgery, cardiac surgery and is found to be effective for improving pulmonary functions. The need of study is to compare both the techniques and find out which one is more effective and implement that with the standard exercises which are used for these patients to help them to improve the quality of life, reduce the hospital stay of the patient and to improve the lung capacity of the patient. |