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CTRI Number  CTRI/2025/04/083835 [Registered on: 01/04/2025] Trial Registered Prospectively
Last Modified On: 26/03/2025
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   4-7-8 breathing technique at 6 versus 8 cycles per set on heart rate variability, blood pressure and oxygen saturation in patients after coronary artery bypass graft surgery. 
Scientific Title of Study   Effect of 4-7-8 breathing control at 6 and 8 cycles per set on heart rate variability, blood pressure, and oxygen saturation in patients after coronary artery bypass graft surgery 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vaishnavi Somsetwar 
Designation  Postgraduate student 
Affiliation  Datta Meghe College of Physiotherapy Nagpur Nagpur 
Address  Department of Cardiovascular and Respiratory Physiotherapy, Datta Meghe College of Physiotherapy, Shri Datta Meghe Polytechnic Campus, Wanadongri Hingna Road Nagpur MAHARASHTRA 441110 India

Nagpur
MAHARASHTRA
441110
India 
Phone  9860651967  
Fax    
Email  somsetwar.vaishnavi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shweta Panchbudhe 
Designation  Associate Professor  
Affiliation  Datta Meghe College of Physiotherapy  
Address  Department of Cardiovascular and Respiratory Physiotherapy, Datta Meghe College of Physiotherapy, Shri Datta Meghe Polytechnic Campus, Wanadongri Hingna Road Nagpur MAHARASHTRA 441110 India

Nagpur
MAHARASHTRA
441110
India 
Phone  9049169589  
Fax    
Email  Shweta12panchbudhe@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Vaishnavi Somsetwar 
Designation  Postgraduate Student 
Affiliation  Datta Meghe College of Physiotherapy  
Address  Department of Cardiovascular and Respiratory Physiotherapy, Datta Meghe College of Physiotherapy, Shri Datta Meghe Polytechnic Campus, Wanadongri Hingna Road Nagpur MAHARASHTRA 441110 India

Nagpur
MAHARASHTRA
441110
India 
Phone  9860651967  
Fax    
Email  somsetwar.vaishnavi@gmail.com  
 
Source of Monetary or Material Support  
Dr Babasaheb Ambedkar Superspeciality Institute, Wanadongri Hingna Road Nagpur  
 
Primary Sponsor  
Name  Datta Meghe College of Physiotherapy  
Address  Shri Datta Meghe Polytechnic Campus, Wanadongri Hingna Road Nagpur MAHARASHTRA 441110 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 Vaishnavi Somsetwar  Dr Babasaheb Ambedkar Superspeciality Institute, wanadongri Hingna Road Nagpur  Cardiovascular and Thoracic Surgery Unit CVTS Ward no. 16 Wanadongri Hingna Road Nagpur MAHARASHTRA 441110
Nagpur
MAHARASHTRA 
9860651967

somsetwar.vaishnavi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Datta Meghe Ayurved, Physiotherapy, Nursing (APN) Colleges Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I778||Other specified disorders of arteries and arterioles,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  4-7-8 breathing control at 6 cycles per set  4-7-8 breathing control at 6 cycles per set is a comparator group frequency 2 times per day intensity 4-7-8 breathing control for six cycles per set and 3 sets are included in one treatment session. Procedure In a peaceful, silent environment, the participants would lay down in a supine position, with their eyes closed slightly and their arms and legs fully extended, to practice this method. The following actions were taken during one cycle of the 4-7-8 breathing control: First, make a whooshing sound with your lips; next, close your mouth, inhale silently through your nose, count to four in your head, and hold your breath for seven seconds. Lastly, make another whooshing sound with your lips, exhaling entirely through your mouth while counting to six in your mind. For five minutes, they were instructed to practice the 4-7-8 breathing control for six cycles per set, with one minute of regular breathing in between each set for 6 days. 
Intervention  4-7-8 breathing control at 8 cycles per set  4-7-8 breathing control at 8 cycles per set is a interventional group frequency 2 times per day intensity 4-7-8 breathing control for eight cycles per set and 3 sets are included in one treatment session. procedure In a peaceful, silent environment, the participants would lay down in a supine position, with their eyes closed slightly and their arms and legs fully extended, to practice this method. The following actions were taken during one cycle of the 4-7-8 breathing control: First, make a whooshing sound with your lips; next, close your mouth, inhale silently through your nose, count to four in your head, and hold your breath for seven seconds. Lastly, make another whooshing sound with your lips, exhaling entirely through your mouth while counting to eight in your mind. For five minutes, they were instructed to practice the 4-7-8 breathing control for eight cycles per set, with one minute of regular breathing in between each set for 6 days.  
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1 Patients of phase 1 cardiac rehabilitation who undergone post-op CABG.
2 Heamodynamically stable.
3 Undergoing non emergency CABG Surgery. 
 
ExclusionCriteria 
Details  1 Patients with severe pulmonary disease.
2 Patients who are on mechanical ventilation for more than 24 hours.
3 Dangerous dysrhythmia (such as atrial fibrillation and ventricular tachycardia). 
 
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 
Heart Rate Variability
 
Postoperative Day 1
Postoperative Day 6 
 
Secondary Outcome  
Outcome  TimePoints 
Blood pressure
Oxygen Saturation 
Postoperative Day 1
Postoperative Day 6 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   17/04/2025 
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)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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 surgical procedure to restore normal blood flow to heart by bypassing the blocked coronary arteries and is considered an important approach for treating coronary heart disease. Cardiac surgical procedures are performed with the aim of prolonging life and improving quality of life. Postoperative physiotherapy, including early mobilization and breathing exercises, is part of standard care during the first days after cardiac surgery, mainly aimed at preventing postoperative complications, improving lung function and postoperative physical recovery. Deep breathing exercises are recommended during the first postoperative period to enhance recovery of pulmonary function. 4-7-8 breathing at 6 and 8 cycles per set is slow paced and deep breathing exercise but their comparative efficacy in CABG patients during Phase 1 of cardiac rehabilitation has been understudied.

This randomized controlled trial aimed to evaluate the effect of 4-7-8 breathing control at 6 and 8 cycles per set on heart rate variability, blood pressure and oxygen saturation in patients after coronary artery bypass graft surgery.

Procedure : Participants will be randomized 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 randomized into Group A(4-7-8 breathing control at 6 cycles per set)  and Group B (4-7-8 breathing control at 8 cycles per set)  using Block randomization technique. Outcomes for the same will be assessed on postoperative day 1 and treatment will be administered from day 1 till day 6 to patients who underwent CABG surgery and later on day 6 outcomes will be reassessed. Data will be collected from both the groups and analyzed using statistical tests for significant differences in heart rate variability, blood pressure and oxygen saturation improvements in Post-CABG patients.

 
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