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CTRI Number  CTRI/2025/02/079998 [Registered on: 06/02/2025] Trial Registered Prospectively
Last Modified On: 21/01/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   Effect of Butekyo and Papworth Breathing Exercise Techniques on Haemodynamic Parameters in Primary Hypertension Patients through Tele-Rehabilitation 
Scientific Title of Study   Effect of Butekyo and Papworth Breathing Exercise Techniques on Haemodynamic Parameters in Primary Hypertension Patients through Tele-Rehabilitation:A single-blinded Randomised controlled 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  Dr Ganesh BR 
Designation  Professor and Head of CVTS department  
Affiliation  Professor and Head of CVTS department  
Address  Sagar Floor Advance physiotherapy center room no.39 CVTS department room no 6 Kle Dr. Prabhakar Kore Hospital Nehru nagar Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  9844857581  
Fax    
Email  drganeshnssofficer@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ganesh BR 
Designation  Professor and Head of CVTS department  
Affiliation  Professor and Head of CVTS department  
Address  Sagar Floor Advance physiotherapy center room no.39 CVTS department room no 6 Kle Dr Prabhakar Kore hospital Nehru nagar Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  9844857581  
Fax    
Email  drganeshnssofficer@gmail.com  
 
Details of Contact Person
Public Query  
Name  Mugdha Vijaykumar Pendse 
Designation  Post- graduate Student  
Affiliation  KAHER Institute of Physiothrapy 
Address  Sagar Floor Advance physiotherapy center room no.39 Nehru nagar Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  9765391857  
Fax    
Email  mugdu08pendse@gmail.com  
 
Source of Monetary or Material Support  
Kle Academy of Higher Education and Research Nehru Nagar Belagavi -590010 
 
Primary Sponsor  
Name  KLE PREBHAKAR KORE HOSPITAL 
Address  Sagar Floor advance physiotherapy centre room no. 39 Kle Dr. Prabhakar Kore hospital Nehru nagar Belagavi  
Type of Sponsor  Private medical college 
 
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 Ganesh BR   DR. PRABHAKAR KORE HOSPITAL  Sagarfloor advanced physiotherapy center room no. 39 Dr. Prabhakar Kore Hospital and MRC Belgaum karnataka
Belgaum
KARNATAKA 		 9844857581

drganeshnssofficer@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KAHER Istitute of Physiotherapy  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I10||Essential (primary) hypertension,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Breathing Exercises 1. Buteyko brething technique 2. Papworth breathing technique   Baseline assesssment will taken and after which for 2 weeks each day through video call sessions excercises will be taught.  
Comparator Agent  Diaphragmatic breathing technique  Baseline assesssment will taken and after which for 2 weeks each day through video call sessions excercises will be taught. 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  All genders clinically diagnosed with clinically with primary hypertension
Age group : 35 – 55 yrs
Patient engaged in some kind of physical activity at least 3 times a week
Patient who have taking medications for hypertension
Patient willing to participate
Smartphone users

 
 
ExclusionCriteria 
Details  with active respiratory infection or kidney problem
with a history of organ transplant
undergoing any cardiac or respiratory rehabilitation program
with history of rib fracture
unwilling to participate
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Blood Pressure
Pulse Rate
Oxygen Saturation
 		 Blood Pressure
Pulse Rate
Oxygen Saturation
Day 0 and at 7th day and at last day that is 14th day
 
 
Secondary Outcome  
Outcome  TimePoints 
Oxygen saturation   Day 0 and day 7 and day 14 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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   Phase 1/ Phase 2 
Date of First Enrollment (India)   07/02/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  07/02/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

The study will obtain ethical clearance from the Institutional Ethical Committee and register with CTRI before initiation. Participants will be selected based on inclusion and exclusion criteria. The purpose and procedures of the study will be explained, and informed consent will be collected. Participants will be randomly allocated into three groups.

Baseline measurements will be taken at a tertiary care hospital during the first session. Daily video call sessions will be conducted to monitor participants. Follow-up visits will occur on the 7th day and the final session to reassess outcome measures.

 
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