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CTRI Number  CTRI/2023/02/049983 [Registered on: 22/02/2023] Trial Registered Prospectively
Last Modified On: 07/11/2023
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   Intense physiotherapy care on lung complication and quality of life after cardiac surgery  
Scientific Title of Study   Effectiveness of Ancillary Cardio-respiratory Therapeutic Regimen on Post Operative Pulmonary Dysfunction and Quality of Life after CABG surgery – A Pilot Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Om Prakash Palanivel 
Designation  Research scholar  
Affiliation  Chettinadu Academy of Research and Education 
Address  Department of Physiotherapy. 2nd floor, Block - A, Chettinadu Academy of Research and Education, Kelambakkam, Chennai, Tamilnadu.

Kancheepuram
TAMIL NADU
603103
India 
Phone  6385127983  
Fax    
Email  omarprakash77@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr P Senthil 
Designation  Professor 
Affiliation  Chettinadu Academy of Research and Education 
Address  Department of Physiotherapy. 2nd floor, Block - A, Chettinadu Academy of Research and Education, Kelambakkam, Chennai, Tamilnadu.

Kancheepuram
TAMIL NADU
603103
India 
Phone  9841667912  
Fax    
Email  senthilp101010@gmail.com  
 
Details of Contact Person
Public Query  
Name  Om Prakash Palanivel 
Designation  Research scholar 
Affiliation  Chettinadu Academy of Research and Education 
Address  Department of Physiotherapy. 2nd floor, Block - A, Chettinadu Academy of Research and Education, Kelambakkam, Chennai, Tamilnadu.
Chettinad Health City, kelambakkam, chennai- 603103. Tamilnadu.
Kancheepuram
TAMIL NADU
603103
India 
Phone  6385127983  
Fax    
Email  omarprakash77@gmail.com  
 
Source of Monetary or Material Support  
Chettinad Academy of Research and Education (CARE) Department of Physiotherapy. 2nd floor, Block - A, Kelambakkam, Chennai-603103, Tamilnadu.  
 
Primary Sponsor  
Name  Chettinad academy of research and education (CARE) 
Address  Kelambakkam, chennai- 603103. 
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 P Senthil  Chettinad Hospital and Research institute (CHRI)  A block, Department of Cardiothoraxic vascular surgery Intensive care unit, kelambakkam, chennai
Kancheepuram
TAMIL NADU 		 9841667912

omarprakash77@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IHEC  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  combined cardio-respiaratory therapeutic regimen  Duration: 45 minutes per session every 8 hours for 3days in CTICU and 30 minutes of session twice daily for 4days Ancillary Cardio Respiratory Therapeutic Protocol which includes Transcutaneous electrical nerve stimulation (TENS), steam inhalation, autogenic drainage, active cycle breathing, Flutter, and Early mobilization. 
Comparator Agent  standard physiotherapy protocol  Duration: 45 minutes per session every 8 hours for 3days in CTICU and 30 minutes of session twice daily for 4 days Breathing exercises, Incentive spirometer, Active movements to all extremities, Thoracic mobility exercise, Chest percussion,clapping and vibrations, Forced expiration technique (FET)  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Good Left Ventricular function, Smokers,
Diabetes, Hypertension, Dyslipidaemia, and Obesity. 
 
ExclusionCriteria 
Details  Chronic liver and renal impairment, unstable angina, Heart failure, pulmonary diseases (COPD and Asthma), COVID-19, Severe cardiac arrhythmia and post-operative uncontrolled diabetes and hypertension, History of stroke and motor disabilities 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Centralized 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Pulmonary function test, Numerical pain rating scale(NPRS) Physical Functional capacity, Quality of Life Length of hospital stay Secondary outcome Heart rate variability during TENS
 		 Baseline, Day 2, Day 7, Day 30 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcome Heart rate variability during TENS  Baseline, Day 2, 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   N/A 
Date of First Enrollment (India)   27/02/2023 
Date of Study Completion (India) 21/10/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  		 Coronary artery bypass graft(CABG) is a major surgical procedure. Approximately 7 million open heart surgeries are performed worldwide annually, and 30% of patients experience major post-operative complications. currently, in India, CABG accounts for more than 60% of all cardiac surgeries performed in India. Generally, after CABG, elevated lactate, and decreased central venous oxygenation promote tissue perfusion, and post-operative pain adversely affects coughing and deep breathing resulting in pulmonary complications, including retention of pulmonary secretion and atelectasis. pneumonia, pleural effusion, respiratory failure, and even death. Combined Non-invasive ventilation therapy, and respiratory and physical exercises have significantly improved the acute phase I of cardio-pulmonary rehabilitation programs and physical functional capacity after CABG. However, critical research gaps persist in preventing the in-patients ’ tissue perfusion and operative pulmonary complications associated with pain, physical functional capacity, and quality of life.
Hypothesis - To emphasize a well-defined ancillary cardio-respiratory therapeutic regimen to increase central venous oxygenation and to reduce post-operative CABG pain in resting and coughing conditions to improve pulmonary functions, physical functional capacity, and quality of life after CABG.
 
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