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CTRI Number  CTRI/2019/09/021195 [Registered on: 12/09/2019] Trial Registered Prospectively
Last Modified On: 11/09/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   AN EXPERIMENTAL STUDY TO COMPARE THE EFFECTS OF TWO BREATHING EXERCISES ON PULMONARY FUNCTION IN ASTHMATIC PATIENTS 
Scientific Title of Study   THE EFFECTIVENESS OF BUTEYKO BREATHING EXERCISE VERSUS SENOBI BREATHING EXERCISE ON PULMONARY FUNCTION IN ASTHMATIC PATIENTS: AN EXPERIMENTAL STUDY 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  VRUTI SAKARIYA 
Designation  Post Graduate Student 
Affiliation  School of physiotherapy RK University 
Address  School of Physiotherapy RK UNIVERSITY Kasturbadham Rajkot Bhavnagar Highway Rajkot Gujarat India

Rajkot
GUJARAT
360020
India 
Phone  9687095610  
Fax    
Email  vsakariya673@rku.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Dr MANSI SANGHVI 
Designation  Assistant Professor School of Physiotherapy RK University 
Affiliation  School of Physiotherapy RK UNIVERSITY 
Address  Dept. of community physiotherapy first floor School of Physiotherapy RK UNIVERSITY Kasturbadham Rajkot Bhavnagar Highway Rajkot Gujarat India

Rajkot
GUJARAT
360020
India 
Phone  9409053462  
Fax    
Email  mansi.shah@rku.ac.in  
 
Details of Contact Person
Public Query  
Name  VRUTI SAKARIYA 
Designation  Post Graduate Student 
Affiliation  School of physiotherapy RK University 
Address  School of Physiotherapy RK UNIVERSITY Kasturbadham Rajkot Bhavnagar Highway Rajkot Gujarat India

Rajkot
GUJARAT
360020
India 
Phone  9687095610  
Fax    
Email  vsakariya673@rku.ac.in  
 
Source of Monetary or Material Support  
SATVIK HOSPITAL 
 
Primary Sponsor  
Name  VRUTI SAKARIYA 
Address  School of Physiotherapy RK UNIVERSITY Kasturbadham Rajkot Bhavnagar Highway Rajkot Gujarat, India 
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 
VRUTI SAKARIYA  Satvik Hospital   1st floor, respiratory department Vidhyanagar main road opp Milestone hospital lifeline building Rajkot
Rajkot
GUJARAT 		 9687095610

vsakariya673@rku.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITEE (IEC), SPT, RKU  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J45||Asthma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  BUTEYKO BREATHING EXERCISE   BUTEYKO BREATHING EXERCISE It aims to normalise breathing pattern by reducing minute ventilation. it includes 2 phases:Control pause followed by Relaxed breathing twice daily for 15 to 30 mins for 1 week 
Comparator Agent  BUTEYKO BREATHING EXERCISE AND SENOBI BREATHING EXERCISE  Both to be given for twice daily for 15 to 30 mins for 1 week 
Intervention  SENOBI BREATHING EXERCISE  It aims to correct the sympathetic nervous system imbalance twice daily for 15 to 30 mins for 1 week 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1)Patients diagnosed with asthma by pulmonologist
2)Patients with mild to moderate persistent asthma
3)Patients with FEV1/PEFR: 50% to 75%
4)Patients willing to participate in study

 
 
ExclusionCriteria 
Details  1)Subjects with other obstructive diseases like COPD, bronchiectasis etc.
2)Subjects with history of severe cardiac disorders like IHD, MI etc.
3)Patients with history of other neurological or orthopaedic conditions
4)Smokers or ex smokers
5)Pregnant women
6)Uncooperative patients 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
PULMONARY FUNCTION TEST
(FEV1,FEV1/FVC,PEFR) 		 DAY 1 AND AFTER 1 WEEK 
 
Secondary Outcome  
Outcome  TimePoints 
SHORT FORM 36 QUESTIONNAIRE  DAY 1 AND AFTER 1 WEEK 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 3 
Date of First Enrollment (India)   12/09/2019 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NOT YET PUBLISHED 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

  • INTRODUCTION:

  • BRONCHIAL ASTHMA is a chronic inflammatory disorder of the airways associated with airway hyper responsiveness that leads to recurrent episodes of wheezing, breathlessness, chest tightness and coughing.

  • The resulting factor seems to be alteration in diet and lifestyle which results in altered activity of autonomic nervous system in these patients.

  • BUTEYKO BREATHING EXERCISE: It aims to correct hyperventilation and normalize the breathing pattern by reducing minute volume and  thus, lead to improvements in asthma control and allow reduction of medication.

  • SENOBI BREATHING EXERCISE: It aims to correct the autonomic nervous system imbalance in asthma patients by activating the sympathetic nerves.

  • Both these exercises are individually effective in asthma control and reduction of medications

  • So the need of this study is to compare buteyko vs senobi breathing exercise in asthma patients.

  • AIM:

  • To evaluate the effect of training program consisting of buteyko breathing exercise and senobi breathing exercise on pulmonary function in asthmatic patients.

  • OBJECTIVES :

  • To study the effect of buteyko breathing exercise on pulmonary function in asthmatic patients.

  • To study the effect of senobi breathing exercise on pulmonary function in asthmatic patients.

  • To compare the effect of buteyko breathing and senobi breathing in asthmatic patients.

  • MATERIALS:

  • Pen, Paper, Eraser, Consent form, Outcome measures, Plinth/chair, PFT machine, Pulse oximeter

  • PROCEDURE:

  • After the approval of study from ethical committee, 30 patients diagnosed with asthma by pulmonologist will be taken.

  • They will be assessed according to the inclusion and exclusion criteria and informed consent will be taken.

  • They will be divided into 2 groups by convenient sampling method.

  • Group A (n=15): buteyko breathing exercise twice daily (60-90 minutes) for 7 days/week for 1 week.

  • Group B (n=15): senobi breathing exercise twice daily (60-90 minutes) for 7 days/week for 1 week.

  • The outcome measure is pulmonary function test (FEV1, FEV1/FVC, PEFR) and short form 36 questionnaire.

  • Pre and post training measurement of data will be done and data analysis will be done using SPSS software (vesion 23).


 
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