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CTRI Number  CTRI/2023/04/052116 [Registered on: 28/04/2023] Trial Registered Prospectively
Last Modified On: 26/04/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Efficacy of Powerbreathe medic plus Device in Coronary Artery Bypass Graft Patients  
Scientific Title of Study   Efficacy of Powerbreathe medic plus Device on maximal inspiratory pressure, functional capacity and quality of life in Coronary Artery Bypass Graft Patients: 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  DrVishnu Vardhan 
Designation  Professor 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Ravi Nair Physiotherapy College, Cardiovascular and Respiratory Physiotherapy Department Datta Meghe Institute of Higher Education and Research,Sawangi (Meghe)
Meghdoot Appartments,G1 4,Sawangi ( Meghe)
Wardha
MAHARASHTRA
442001
India 
Phone  8379917421  
Fax    
Email  vishnudiwakarpt@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrVishnu Vardhan 
Designation  Professor 
Affiliation  Ravi Nair Physiotherapy College,Datta Meghe Institute of Higher Education and Research 
Address  Ravi Nair Physiotherapy College Cardiovascular and Respiratory Physiotherapy Department Datta Meghe Institute of Higher Education and ResearchSawangi (Meghe)
Meghdoot Appartments,G1 4,Sawangi ( Meghe)
Wardha
MAHARASHTRA
442001
India 
Phone  8379917421  
Fax    
Email  vishnudiwakarpt@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrVishnu Vardhan 
Designation  Professor 
Affiliation  Ravi Nair Physiotherapy College,Datta Meghe Institute of Higher Education and Research 
Address  Ravi Nair Physiotherapy College Cardiovascular and Respiratory Physiotherapy Department Datta Meghe Institute of Higher Education and Research,Sawangi (Meghe)
Meghdoot Appartments,G1 4,Sawangi ( Meghe)
Wardha
MAHARASHTRA
442001
India 
Phone  8379917421  
Fax    
Email  vishnudiwakarpt@gmail.com  
 
Source of Monetary or Material Support  
Datta Meghe Institute of Higher Education and Reseach has funded for Respiratory MicroRPM Respiratory Pressure Meter Device. 
 
Primary Sponsor  
Name  Ravi Nair Physiotherapy College,Datta Meghe Institute of Higher Education & Research 
Address  Ravi Nair Physiotherapy College,Datta Meghe Institute of Higher Education & Research 
Type of Sponsor  Research institution and hospital 
 
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 
DrVishnu Vardhan  Acharya Vinobha Bhave Rural Hospital  Cardiovascular Surgery Department, Sawangi ( Meghe)
Wardha
MAHARASHTRA 
8379917421

vishnudiwakarpt@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITEE- DATTA MEGHE INSTITUTE OF MEDICAL SCIENCES  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I798||Other disorders of arteries, arterioles and capillaries in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Chest Physiotherapy exercises   Conventional Chest Physiotherapy exercises will be given in the form of Diaphragmatic breathing exercise,Thorasic expansion exercises,Incentive spirometry.he duration of intervention is given for two weeks. 
Intervention  Powerbreathe Medic Plus Device  This is a respiratory device that uses Respiratory Muscle Training (RMT) against resistance to improve respiratory muscle strength by breathing through various sized orifices. The device improves both inspiratory and expiratory muscle strength by applying resistance to both portions of the breath cycle. It may be adjusted and has its power source. The duration of intervention is given for two weeks. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Patients who will sign the informed consent form.
2.Both the male and female patients.
3.Patients who had undergone Coronary artery bypass graft patients with age group of 40-70 years.

 
 
ExclusionCriteria 
Details  1. Patients who had developed hemodynamic complications (e.g. preoperative Myocardial Infarction, Lung Congestion, Post-operative renal failure, patients on Intra-aortic balloon pump or arrhythmia needed for a pacemaker).
2. CABG patient on Post-operative mechanical ventilation (more than 24 hours).
3. No previous neurological complications in last 6 months.
4. Unstable angina

 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
• Maximal Inspiratory Pressure (PImax)
• Six minute walk distance
 
Two Weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Six Minute Walk Distance  Two Weeks 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
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)   30/04/2023 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

In cardiac surgery patients, decreased Respiratory Muscle Strength has been associated with decreased functional capacity and has contributed to a prolonged period of recovery of lung function and the occurrence of physical deconditioning, which can last for several weeks. Respiratory repercussions also generate changes in RMS, as well as changes in lung volumes and capacities, alveolar dysfunction, depression of central respiratory stimulation, and mechanical disorders of thoracic function. In addition, it is known that most cardiac surgery patients present with episodes of muscle weakness in the preoperative period, which is accentuated after the surgical procedure. However, this muscle weakness is more noticeable in the respiratory muscles than in the peripheral muscles, although the latter muscles are also inactive.After coronary artery bypass graft (CABG) surgery, Postoperative pulmonary complications [PPCs] are a major source of morbidity and mortality, and increase length of hospital stay and resource utilization. Post operative inspiratory muscle training (IMT) efficacy in reducing the incidence of PPCs in high-risk patients undergoing CABG surgery has not yet been determined. Therefore, the present study is to determine the efficacy of Powerbreathe medic plus device on maximal inspiratory pressure, functional capacity and quality of life in Coronary Artery Bypass Graft Patients.

 
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