| CTRI Number |
CTRI/2022/12/048295 [Registered on: 20/12/2022] Trial Registered Prospectively |
| Last Modified On: |
26/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Buteyko Breathing Technique on Pulmonary function in Off pump Coronary Artery Bypass Surgery patients |
|
Scientific Title of Study
|
“Effect of Buteyko Breathing Technique as an adjunct to routine physiotherapy on pulmonary functions in patients undergone off pump Coronary Artery Bypass Surgery: A Randomized Controlled Trial†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Snehal Mavkar |
| Designation |
Postgraduate Student |
| Affiliation |
MGM Institute of Physiotherapy |
| Address |
Department of Cardiovascular and Respiratory Physiotherapy, OPD No-4, MGM Institute of Physiotherapy
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
8805541973 |
| Fax |
|
| Email |
snehalmavkar08@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manish Shukla |
| Designation |
Associate Professor |
| Affiliation |
MGM Institute of Physiotherapy |
| Address |
Department of Cardiovascular and Respiratory Physiotherapy, OPD No-4, MGM Institute of Physiotherapy
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9960290614 |
| Fax |
|
| Email |
manish.shukla20@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Snehal Mavkar |
| Designation |
Postgraduate Student |
| Affiliation |
MGM Institute of Physiotherapy |
| Address |
Department of Cardiovascular and Respiratory Physiotherapy, OPD No-4, MGM Institute of Physiotherapy
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
8805541973 |
| Fax |
|
| Email |
snehalmavkar08@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM Institute of Physiotherapy, N-6,CIDCO,Aurangabad 431003 |
|
|
Primary Sponsor
|
| Name |
MGM Institute of Physiotherapy |
| Address |
N-6 Cidco, Aurangabad 431003 |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Snehal Mavkar |
MGM Medical College and Hospital |
Department of Cardiovascular and Thoracic Surgery, 1st floor, N-6 Cidco
Aurangabad
MAHARASHTRA |
8805541973
snehalmavkar08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MGM Institute of Physiotherapy Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I257||Atherosclerosis of coronary arterybypass graft(s) and coronary artery of transplanted heart with angina pectoris, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Buteyko breathing technique with conventional physiotherapy |
This Buteyko breathing technique will be given from post operative day 2 along with conventional physiotherapy
Frequency - Twice a day
Duration - One session of 15 minutes |
| Comparator Agent |
Conventional physiotherapy |
This group will be given Cardiac Rehabilitation phase 1 as a conventional physiotherapy
Frequency - Twice a day
Duration - 15 minutes |
|
|
Inclusion Criteria
|
| Age From |
48.00 Year(s) |
| Age To |
71.00 Year(s) |
| Gender |
Both |
| Details |
1. Age between 48 to 71 years
2. Both male and female
3. Patients with off pump Coronary Artery Bypass Surgery |
|
| ExclusionCriteria |
| Details |
1. Patients on mechanical ventilation (>24 hours)
2. mMRC dyspnea grade < 2
3. Renal failure patients
4. Hemodynamically unstable patients
5. Loss of consciousness
6. Previous history of cardiac surgery
7. Any pulmonary disease |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| Pulmonary Function Test |
10 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Breath holding test |
5 minutes |
| Chest expansion by inch tape |
10 minutes |
|
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Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="66" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
23/12/2022 |
| Date of Study Completion (India) |
31/07/2023 |
| 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)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Planned for publication |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Objectives - 1. To compare the effect of Buteyko Breathing Technique in adjunct to routine physiotherapy versus routine physiotherapy intervention alone on Pulmonary Function Test, Breath holding time and Chest expansion in patients undergone off pump Coronary Artery Bypass surgery. 2. To see effect of Buteyko Breathing Technique on Pulmonary Function Test, Breath holding time and Chest expansion in patients undergone off Pump Coronary Artery Bypass surgery. 3. To see effect of Routine physiotherapy intervention on Pulmonary Function Test, Breath holding time and Chest expansion in patients undergone off pump Coronary Artery Bypass surgery
Design - Randomized Controlled Trial
Study Setting - Tertiary Care Hospital
Procedure - Patients with off pump Coronary Artery Bypass Surgery will be included according inclusion criteria. Patients will be divided in two groups Group 1 Experimental group and Group 2 Control group. Before collection of data, Informed written and verbal consent will be taken from all the patients. Pre-treatment parameters are taken on POD 2 (PFT, breath holding time and chest expansion) of both groups. Routine physiotherapy intervention along with Buteyko breathing technique is started from POD 2 in experimental group and Routine physiotherapy intervention is started from POD 2 in control group. Treatment will be given from post operative day 2 to post operative day 7 in both groups. On POD 7, all outcome measures will be reassessed.
Buteyko Breathing Technique procedure - • Sit in upright chair and adopt a good posture • Relax your shoulders and rest your lower back against the back of chair • Do not change your breathing before taking a control pause. Take a small breath in (2s) and a small breath out (3s) • Hold your nose on the “out†breath, with a empty lungs but not too empty. • Holding your nose is necessary to prevent air entry into airways. • Count how many seconds you can comfortably last before you feel first urge of breathing. • Release your nose and breath in through it. • Your first intake of breath after the control pause should be no greater than your breath prior to taking measurement, you should not hold your breath for too long as this may cause you to take a big breath after measuring control pause. Dosage - • Patient will practice Buteyko Breathing Technique two times a day • Duration – 5 minutes • Frequency – 7 consecutive days
Control group – Cardiac Rehabilitation phase 1 exercises will be given which include lying or half lying, Relaxed passive movements, Free active exercises, Variation on bed rest program, Chair sitting, Ambulation and Incentive Spirometry
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