CTRI Number |
CTRI/2021/10/037560 [Registered on: 25/10/2021] Trial Registered Prospectively |
Last Modified On: |
06/04/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Physiotherapy (Not Including YOGA) |
Study Design |
Other |
Public Title of Study
|
COMPARISON OF EXPIRATORY AND INSPIRATORY MUSCLE TRAINING ALONG WITH BUTEYKO BREATHING TECHNIQUE ON RESPIRATORY MUSCLE STRENGTH, PEAK EXPIRATORY COUGH FLOW, EXERCISE CAPACITY AND BREATHLESSNESS IN POST CABG PATIENTS.- RANDOMISED CLINICAL TRIAL |
Scientific Title of Study
|
COMPARISON OF EXPIRATORY AND INSPIRATORY MUSCLE TRAINING ALONG WITH BUTEYKO BREATHING TECHNIQUE ON RESPIRATORY MUSCLE STRENGTH, PEAK EXPIRATORY COUGH FLOW, EXERCISE CAPACITY AND PERCIEVED DYSPNEA IN POST CABG PATIENTS.- RANDOMISED CLINICAL TRIAL |
Trial Acronym |
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Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Christy Tomy |
Designation |
PG student |
Affiliation |
KLE UNIVERSITY |
Address |
Department of CVTS physiotherapy,KAHER Institute of Physiotherapy Belagavi, Karnataka, India, 590010 KAHER Institute of Physiotherapy Belagavi, Karnataka, India, 590010 Belgaum KARNATAKA 590010 India |
Phone |
9071938676 |
Fax |
|
Email |
christy2597@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Ganesh BR |
Designation |
professor |
Affiliation |
KLE UNIVERSITY |
Address |
Department of CVTS physiotherapy, KAHER Institute of Physiotherapy Belagavi, Karnataka, India, 590010 KAHER Institute of Physiotherapy Belagavi, Karnataka, India, 590010 Belgaum KARNATAKA 590010 India |
Phone |
|
Fax |
|
Email |
drganeshnssofficer@gmail.com |
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Details of Contact Person Public Query
|
Name |
Ganesh BR |
Designation |
professor |
Affiliation |
KLE UNIVERSITY |
Address |
Department of CVTS physiotherapy,KAHER Institute of Physiotherapy Belagavi, Karnataka, India, 590010 KAHER Institute of Physiotherapy Belagavi, Karnataka, India, 590010 Belgaum KARNATAKA 590010 India |
Phone |
|
Fax |
|
Email |
drganeshnssofficer@gmail.com |
|
Source of Monetary or Material Support
|
KAHER Institute of Physiotherapy |
|
Primary Sponsor
|
Name |
KAHER Institute of Physiotherapy |
Address |
KAHER Institute of Physiotherapy, Belgaum |
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 |
Christy Tomy |
kles Dr Prabhakar Kore Charitable Hospital |
ITU and post op wards, KLE hospital, Belagavi, Karnataka, India, 590010 Belgaum KARNATAKA |
9071938676
christy2597@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
KLE Institute of Physiotherapy |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: I971||Other postprocedural cardiac functional disturbances, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
EXPIRATORY MUSCLE TRAINING |
Expiratory muscle training will be given to the participant using an expiratory muscle trainer device (EMST 150) with a resistive load of 30 cm H2O, the resistance will be increased according participant tolerance in the following days. Training will be given for 15 minutes |
Intervention |
inpiratory muscle training |
Inspiratory muscle training will be given to participants using a inspiratory muscle trainer device. The participant will start breathing at 15% of their maximal inspiratory muscle strength for 15 minutes. The resistance will be increased between 15% and 45% based on participants tolerance in the following days |
|
Inclusion Criteria
|
Age From |
37.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
Participants between the age group of 35-70 years of all genders.
• Participants undergoing planned CABG who are willing to participate in the study.
• Spontaneously breathing and clinically stable participants. |
|
ExclusionCriteria |
Details |
ï‚— Participants with co morbidities requiring strict medical monitoring
ï‚— Not alert or able to participate in the training.
ï‚— Participants who participated in any respiratory training pre surgery
ï‚— Post-operative mechanical ventilation (more than 24 hours) |
|
Method of Generating Random Sequence
|
Other |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Maximal expiratory and Inspiratory pressure
|
pre operative, day 1, day 8 |
|
Secondary Outcome
|
Outcome |
TimePoints |
Functional capacity |
pre operative, day 1, day 8 |
Peak expiratory cough flow |
pre operative, day 1, day 8 |
Modified medical research council dyspnea scale |
pre operative, day 1, day 8 |
|
Target Sample Size
|
Total Sample Size="36" Sample Size from India="36"
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)
|
07/11/2021 |
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="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
The respiratory musculature comprises of inspiratory and expiratory muscles with focus, to date, on inspiratory muscle training (IMT). Evidence suggests that inspiratory and expiratory muscle weakness varies between diseases with expiratory muscles shown to weaken to a lesser extent than inspiratory in patients with COPD, but to a greater extent in MS. Therefore determining the extend of weakness of each muscle group separately in CABG would be of great importance when planning the rehabilitation protocol. The expiratory muscles were specifically trained in several settings other than CABG like multiple sclerosis, neuromuscular diseases and healthy adults. Such training tended to enhance respiratory muscle strength, cough efficacy, reduction in the sensation of respiratory effort and dyspnoea during exercise.Buteyko breathing technique (BBT) is a breathing control exercise originally developed for asthmatic patients. Few studies aimed to compare the effect of BBT and spirometric training on arterial blood gases and breath holding time after CABG. To the best of our knowledge no studies till date have evaluated the effect of BBT on lung function, peak expiratory cough flow, exercise capacity and perceived dyspnoea or the additive effect of BBT with respiratory muscle training in post CABG patients. |