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CTRI Number  CTRI/2025/04/083829 [Registered on: 01/04/2025] Trial Registered Prospectively
Last Modified On: 11/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Acapellla versus Aerobika on airway clearance and pulmonary Function in coronary artery disease patients  
Scientific Title of Study   Effect of Acapella versus Aerobika on Airway clearance and Pulmonary in CABG patients during phase 1 cardiac rehabilitation: comparative study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pragati Joshi 
Designation  Postgraduate Student  
Affiliation  Datta Meghe college of physiotherapy, Nagpur. 
Address  Department of Cardiovascular and Respiratory Physiotherapy, Datta Meghe College of Physiotherapy, Shri Datta Meghe Polytechnic Campus Wanadongri,Hingna Road, Nagpur 441110 MAHARASHTRA India

Nagpur
MAHARASHTRA
441110
India 
Phone  9623010721  
Fax    
Email  jpragati143@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Manish P Shukla 
Designation  Professor  
Affiliation  Datta Meghe College of Physiotherapy, Nagpur  
Address  Department of Cardiovascular and Respiratory Physiotherapy, Datta Meghe College of Physiotherapy, Shri Datta Meghe Polytechnic Campus Wanadongri,Hingna Road, Nagpur 441110 MAHARASHTRA India

Nagpur
MAHARASHTRA
441110
India 
Phone  9960290614  
Fax    
Email  manish.shukla20@gmail.com  
 
Details of Contact Person
Public Query  
Name  Pragati Joshi 
Designation  Postgraduate student  
Affiliation  Datta Meghe College of Physiotherapy,Nagpur  
Address  Department of Cardiovascular and Respiratory Physiotherapy, Datta Meghe College of Physiotherapy, Shri Datta Meghe Polytechnics Campus Wanadongri,Hingna Road, Nagpur 441110 MAHARASHTRA India

Nagpur
MAHARASHTRA
441110
India 
Phone  9623010721  
Fax    
Email  jpragati143@gmail.com  
 
Source of Monetary or Material Support  
Dr. Babasaheb Ambedkar Superspeciality Institute, Wanadongri Hingna Road, Nagpur 441110 Maharashtra India  
 
Primary Sponsor  
Name  Datta Meghe College of Physiotherapy  
Address  Shri Datta Meghe Polytechnic Campus Wanadongri,Hingna Road, Nagpur 441110 MAHARASHTRA India 
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 
Dr Pragati Pandharinath Joshi  Dr Babasaheb Ambedkar Superspeciality Institute.  Cardiovascular and Thoracic Surgery Department CVTS Ward no:16 Dr Babasaheb Ambedkar Superspeciality Institute, Wanadongri Hingna Road Nagpur
Nagpur
MAHARASHTRA 		 9623010721

jpragati143@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Datta Meghe ayurved, physiotherapy, nursing (APN) colleges,Institutional Ethics committee (IEC)   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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, (2) ICD-10 Condition: I00-I99||Diseases of the circulatory system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Acapella Device  Patient position - iHigh sitting Frequency- 2 times a day Intensity - This cycle of 8-10 breaths in Acapella followed by 2-3 huffs will be repeated 4-6 times Duration - 30 to 40 minutes  
Intervention  Aerobika Device  Position- High sitting Frequency- 2 times per day Intensity- 10 to 20 breaths followed by 2 to 3 huffcough for clearing the airways Duration- 30 to 40 minutes  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Both male and female underwent through CABG surgery
2.Patients without any respiratory conditions.
3.Undergoing non-emergency surgery
 
 
ExclusionCriteria 
Details  1.History of open-heart surgery
2.Mechanical ventilation longer than 24 hr after surgery
3.Haemodynamic instability
4.Initiation of early complications after surgery (cardiac shock, severe hypotension, bleeding, cardiac tamponade, kidney dysfunction)
5.Dangerous dysrhythmia (such as atrial fibrillation and ventricular tachycardia)
6.Loss of consciousness
7.Cerebral difficulties
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Sputum Volume
Pulmonary Function Test ( PFT )
1.FEV1
2.FVC
3.FEV1/FVC Ratio
4.PEF
 		 Postoperative Day 4 and Postoperative Day 6 
 
Secondary Outcome  
Outcome  TimePoints 
Cough Scale
Chest X Ray Findings 		 Postoperative Day 4 and Postoperative Day 6 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/04/2025 
Date of Study Completion (India) Date Missing 
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)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Coronary artery bypass grafting (CABG) is a common surgical procedure that often results in impaired pulmonary function and reduced airway clearance due to postoperative pain, immobility, and mechanical ventilation. Physiotherapy intervention during early cardiac rehabilitation can improve pulmonary function and reduce respiratory complications. The Acapella and Aerobika devices are two commonly used tools but their comparative efficacy in CABG patients during Phase 1 of cardiac rehabilitation has not been well studied.

 

This randomized clinical trial aimed to evaluate and compare the effects of Acapella and Aerobika on airway clearance and pulmonary function in patients who underwent CABG during Phase 1 of their cardiac rehabilitation. 

Procedure : Participants will be selected and screened based on inclusion and exclusion criteria. Details about the study and intervention will be explained to the participants and an informed written consent form will be obtained. Patient’s will be Randomly divided through block randomisation method into Group A ( Acapella ) and Group B ( Aerobika). Outcomes will be assessed on postoperative day 2 and treatment will be given from POD 2 to POD 6 to Patients who underwent through CABG surgery. On Postoperative day 6 outcomes will be reassessed. Data will be collected from both groups and analyzed for significant differences in pulmonary function and airway clearance improvements. Statistical tests will be used to compare the efficacy of Acapella and Aerobika devices in enhancing respiratory outcomes in post-CABG patients.

 
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