| CTRI Number |
CTRI/2025/07/091636 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
24/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A study to assess the impact of Buteyko Breathing Technique on breathing ability, physical activity, and quality of life in people with asthma. |
|
Scientific Title of Study
|
Effect of Buteyko Breathing Technique on pulmonary function, functional capacity and quality of life in patients with bronchial asthma |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Saril |
| Designation |
pg student |
| Affiliation |
Pt.B.DSharma university of health sciences ,rohtak |
| Address |
Department of physiotherapy,PGIMS,Rohtak,Haryana
Rohtak
Rohtak,Haryana
Rohtak
HARYANA
124001
India |
| Phone |
08168229459 |
| Fax |
|
| Email |
sarilnain1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suman Mehra |
| Designation |
associate professor |
| Affiliation |
Pt.B.DSharma university of health sciences ,rohtak |
| Address |
Department of physiotherapy,PGIMS,Rohtak,Haryana
Rohtak
HARYANA
124001
India |
| Phone |
08814063412 |
| Fax |
|
| Email |
sumanmehra2017@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suman Mehra |
| Designation |
associate professor |
| Affiliation |
Pt.B.DSharma university of health sciences ,rohtak |
| Address |
Department of physiotherapy,PGIMS,Rohtak,Haryana
Rohtak
HARYANA
124001
India |
| Phone |
08814063412 |
| Fax |
|
| Email |
sumanmehra2017@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt. B.D. Sharma University of Health Sciences, Rohtak |
|
|
Primary Sponsor
|
| Name |
Pt. B.D. Sharma University of Health Sciences, Rohtak |
| Address |
Pt. B.D. Sharma University of Health Sciences, PGIMS Campus,
Rohtak, Haryana – 124001, India |
| Type of Sponsor |
Government medical college |
|
|
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 Saril |
Pt. B.D. Sharma University of Health Sciences |
room no 126,out patient department of Department of Pulmonary and Critical Care Medicine
Rohtak
HARYANA |
8168229459
sarilnain1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee (BREC), Pt. B. D. Sharma PGIMS/UHS, Rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J452||Mild intermittent asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Buteyko Breathing Technique
|
3 days/week for 4 weeks |
| Comparator Agent |
Core Strengthening Exercises |
3 days/week for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Clinically diagnosed cases of mild to moderate bronchial asthma. |
|
| ExclusionCriteria |
| Details |
1. Patients who are mechanically ventilated
2. Patients with epilepsy, carcinoma of lung, pulmonary tuberculosis, rib fracture and hypertension
3. Patients with recent abdominal or thoracic surgery, comorbid heart diseases, intermittent claudication |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pulmonary Function, Functional Capacity and Quality of Life |
week 0 and week 4 |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
10/08/2025 |
| 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="0"
Months="10"
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
|
This randomized controlled trial aims to evaluate the effect of Buteyko Breathing Technique on pulmonary function, functional capacity, and quality of life in individuals with bronchial asthma. A total of [60] participants will be randomly assigned into two groups using simple randomization.Group A will receive the Buteyko Breathing Technique along with core muscle training.Group B will receive Core Muscle Training.The intervention will be conducted over a period of [insert duration, e.g., 6 weeks], and assessments will be done at baseline and post-intervention.The primary outcomes include pulmonary function and functional capacity, while the secondary outcome is quality of life.The study will be conducted at the Department of Physiotherapy, Pandit B.D. Sharma PGIMS, Rohtak. |