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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   
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  
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.
 
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