| CTRI Number |
CTRI/2024/07/071041 [Registered on: 23/07/2024] Trial Registered Prospectively |
| Last Modified On: |
20/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [ Respiratory Physiotherapy using Buteyko Breathing Technique] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Breathing technique in children with Asthma |
|
Scientific Title of Study
|
Buteyko breathing technique in children with asthma-Open label randomized 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 GAWALI AISHWARYA BALASAHEB |
| Designation |
Junior Resident 1 |
| Affiliation |
Department of Pediatrics, Government Medical College and Hospital, Aurangabad |
| Address |
Department of Peadiatrics,Surgical building, Ward number 24,Government Medical College and Hospital,Aurangabad(chhatrapati Sambhajinagar),431001
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9096779304 |
| Fax |
|
| Email |
aishwaryagawali1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Trupti Gujarati Joshi |
| Designation |
Associate Professor |
| Affiliation |
Department of Pediatrics, Government Medical College and Hospital, Aurangabad |
| Address |
Department of Pediatrics. Surgical building, ward no 24, Government Medical College and Hospital, Aurangabad(Chhatrapati
Sambhajinagar)
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9823900642 |
| Fax |
|
| Email |
drtruptijoshi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR GAWALI AISHWARYA BALASAHEB |
| Designation |
Junior Resident 1 |
| Affiliation |
Department of Pediatrics, Government Medical College and Hospital, Aurangabad |
| Address |
Department of Peadiatrics,Surgical building, Ward number 24,Government Medical College and Hospital,Aurangabad(chhatrapati Sambhajinagar),431001
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9096779304 |
| Fax |
|
| Email |
aishwaryagawali1998@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Gawali Aishwarya Balasaheb, Junior Resident, Department of Pediatrics,Ward 24, Surgical
Building,Government Medical College and Hospital, Aurangabad(Chhatrapati Sambhajinagar), Maharashtra, India, Pin code 431001 |
|
|
Primary Sponsor
|
| Name |
Dr Gawali Aishwarya Balasaheb |
| Address |
Department of Pediatrics. Surgical building, ward 24, Government Medical College and Hospital, Aurangabad(Chhtrapati Sambhajinagar), Maharashtra, India, Pin code 431001 |
| Type of Sponsor |
Other [Self Sponsored] |
|
|
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 GAWALI AISHWARYA |
Government Medical College and Hospital, Chhatrapati Sambhajinagar |
Opd building,Opd number 133,Department of pediatrics,Government Medical College and Hospital, Aurangabad,431001
Aurangabad
MAHARASHTRA |
9096779304
aishwaryagawali1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL EHICS COMMITTEE, GOVT MEDICAL COLLEGE AURANGABAD |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J453||Mild persistent asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Buteyko Breathing technique |
Participants allocated to Buteyko group will be taught Buteyko breathing technique during first week of enrollment and they will perform Buteyko breathing technique two times a day for ten minutes each for three months under parental super vision along with protocol based asthma management. |
| Comparator Agent |
Control group |
Participants allocated to control group will receive protocol based asthma management. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
children of above mentioned age group enrolled in asthma clinic at tertiary care centre |
|
| ExclusionCriteria |
| Details |
Parents denying consent for therapy
Children receiving any other alternative therapies(Pranayama, Buteyko technique)
Children not cooperative with spirometry and Buteyko breathing technique |
|
|
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 |
| 1)To measure the change on symptom controll,acute exacerbation,need for reliever medication,and school absentism(measured using Asthma controll questionare) and Peak Expiratory flow rate measurement after implementing Buteyko breathing technique. |
At baseline,after 1 month,after 2 months and after 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To measure the change in PFT(FEV1 at rest,FEV1 after excercise,FEV1 after bronchodilator) and FEV1/FVC Ratio after 3 months of implementing Buteyko breathing technique.
2) Pediatric Asthma Quality of life questionnaire survey of all participants and their parents at baseline and after 3 months of giving Buteyko breathing technique. |
At baseline and after 3 months of implementing technique. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
02/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
02/08/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
Asthma is most common chronic disease of childhood. Complimentary therapies like the Buteyko breathing technique plays an essential role in the management. Various studies involving the Buteyko breathing technique in adults have shown good results, but studies related to pediatric asthma are rare. In asthma, there is CO2 washout which will lead to airway constriction and hence producing the symptoms. The Butyeko approach seeks to reduce airflow by teaching patients the best way to hold their breath at the functional residual capacity. It helps improve asthma control and quality of life index. Previous studies in children revealed that this technique has helped improve the symptoms reduced medication use but has not affected physiological parameters. Hence we plan to study the efficacy of this technique in improving asthma symptoms, pulmonary functions and quality of life index. |