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CTRI Number  CTRI/2024/04/065743 [Registered on: 16/04/2024] Trial Registered Prospectively
Last Modified On: 06/04/2024
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   The effect of alternate nostril breathing (anulom vilom) versus diaper breathing on heart rate variability in phase 1 of cardiac rehab for bypass surgery patients (coronary). 
Scientific Title of Study   The effectiveness of alternate nostril breathing in comparison to diaphragmatic breathing exercises on heart rate variability in the early phase of cardiac rehabilitation in coronary artery bypass surgery patients. A randomized control trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dhruvi Bhavin Doshi 
Designation  Post-graduate student 
Affiliation  Terna Physiotherapy College 
Address  3rd Floor Terna Physiotherapy College, Terna Medical College Campus Sector 12 Phase II Nerul(W), Navi Mumbai, Maharashtra 400706.

Thane
MAHARASHTRA
400706
India 
Phone  8169889750  
Fax  ---  
Email  dhruvidoshi15@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sridhar shirodkar 
Designation  Associate professor  
Affiliation  Terna Physiotherapy College 
Address  3rd Floor Terna Physiotherapy College, Terna Medical College Campus Sector 12 Phase II Nerul(W), Navi Mumbai, Maharashtra 400706.

Thane
MAHARASHTRA
400706
India 
Phone  8692919922  
Fax    
Email  Shirodkarsridhar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sridhar Shirodkar 
Designation  Associate- Professor  
Affiliation  Terna Physiotherapy College 
Address  3rd Floor Terna Physiotherapy College, Terna Medical College Campus Sector 12 Phase II Nerul(W), Navi Mumbai, Maharashtra 400706.

Thane
MAHARASHTRA
400706
India 
Phone  8692919922  
Fax    
Email  shirodkarsridhar@gmail.com  
 
Source of Monetary or Material Support  
Terna Speciality Hospital and Research center Plot no 12, Sector 22, Phase 2, opp. Railway Station, Nerul West, Navi Mumbai, Maharashtra 400706 
 
Primary Sponsor  
Name  Dhruvi Bhavin Doshi 
Address  3rd Floor Terna Physiotherapy College, Terna Medical College Campus Sector 12 Phase II Nerul(W), Navi Mumbai, Maharashtra 400706. 
Type of Sponsor  Other [Self] 
 
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 Sridhar Shirodkar  Terna Specialty Hospital and Research Center   Department of physiotherapy, 1st floor, room no. 117, Terna speciality hospital and research center, Plot no 12, Sector 22, Phase 2, opp. Railway Station, Nerul West, Navi Mumbai, Maharashtra 400706
Thane
MAHARASHTRA 		 8692919922

shirodkarsridhar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The institutional ethics committee of Terna medical college   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  Alternate nostril breathing  Alternate nostril breathing exercise will be given along with traditional phase 1 cardiac rehab, in place of the compactor agent which is diaphragmatic breathing. frequency and time- once a day for 5 days. 2 sets of 12 repetitions. 
Comparator Agent  Diaphragmatic breathing exercises  Diaphragmatic breathing exercise along with traditional phase 1 cardiac rehab frequency and time- once a day for 5 days. 1 set of 12 repetitions. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Male and Female post op CABG pts 
 
ExclusionCriteria 
Details  1. Internal pacemakers
2. External pacemakers
3. Patients on ventilator
4. Arrhythmias
5. Heart Block
6. Unstable Angina
7. Atrial Fibrillation
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Heart Rate Variability  3-5 days post operation, done pre and post exercise
 
 
Secondary Outcome  
Outcome  TimePoints 
Blood Pressure  3-5 days post operation, done pre and post exercise
 
Respiratory Rate  3-5 days post operation, done pre and post exercise
 
Heart Rate  3-5 days post operation, done pre and post exercise
 
Blood Oxygen Saturation  3-5 days post operation, done pre and post exercise
 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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)   23/04/2024 
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="0"
Months="3"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [dhruvidoshi15@gmail.com].

  6. For how long will this data be available start date provided 25-09-2024 and end date provided 25-09-2027?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study is a randomized control trial, comparing the effects of alternate nostril breathing and diaphragmatic breathing exercises on heart rate variability in post operated coronary artery bypass graft patients. 
The study will be conducted in one center in India. 
The outcome measures used will be calculated on a daily basis throughout the treatment protocol. One group will be given traditional cardiac rehabilitation, and in the other group, diaphragmatic breathing of traditional rehabilitation will be replaced by alternate nostril breathing.
The purpose of the study is to find out if alternate nostril breathing has a better or an equal effect on heart rate variability compared to diaphragmatic breathing.
Can we replace diaphragmatic breathing and use alternate nostril breathing in phase one of cardiac rehab.
 
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