| 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
|
|
|
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
|
|
|
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. |