| CTRI Number |
CTRI/2026/03/105885 [Registered on: 10/03/2026] Trial Registered Prospectively |
| Last Modified On: |
09/03/2026 |
| 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
|
A comparative study of Home Based Breathing Exercises (ACBT vs Diaphragmatic Breathing) for improving Health and Daily Life in Indian Adults with Asthma : A randomized controlled Trial. |
|
Scientific Title of Study
|
The Efficacy of Home-Based Pulmonary Rehabilitation Using Breathing Exercises (ACBT vs Diaphragmatic Breathing) on Functional Status, Dyspnea, Quality of Life, Depression, Stress, and Sleep Quality in Indian Adults with Asthma: A 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 |
Mrs Ambreen fatima |
| Designation |
Assistant professor |
| Affiliation |
Galgotias university Greater noida |
| Address |
Room no 2 ,Department of physiotherapy,Galgotias university,plot no.2 Sector 17A Yamuna Expressway opposite the Buddh International Circuit in Greater Noida Gautam Buddh Nagar
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9760084221 |
| Fax |
|
| Email |
Ambreen.fatima@galgotiasuniversity.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Ambreen fatima |
| Designation |
Assistant professor |
| Affiliation |
Galgotia university |
| Address |
E-004,Galgotias university plot no2 ,greater noida
B-328,Galgotias university plot no2 ,greater noida
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9760084221 |
| Fax |
|
| Email |
Ambreen.fatima@galgotiasuniversity.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Sonal Arya |
| Designation |
Student |
| Affiliation |
Galgotias university |
| Address |
Room no. B-228 Department of physiotherapy,Galgotias university Plot No. 2, Sector 17A, Yamuna Expressway, opposite the Buddh International Circuit in Greater Noida, Gautam Buddh Nagar
Flexlife physiotherapy clinic ,Delta1 greater noida
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
7291910043 |
| Fax |
|
| Email |
Aryagujjar5566@gmail.com |
|
|
Source of Monetary or Material Support
|
| Research and Development cell, Galgotias University, Plot No2, Sector 17A, Opposite Yamuna Expressway, Greater Noida, Gautam Buddha Nagar UTTAR PRADESH 203201 India |
|
|
Primary Sponsor
|
| Name |
Galgotia university |
| Address |
B228 Galgotias university plot no2 sector 17A Greater Noida |
| Type of Sponsor |
Research institution |
|
|
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 |
| Ambreen Fatima |
Galgotias university Greater Noida |
Room no. B228 ,Galgotias university Plot no. 2 , sector 17A Yamuna expressway
Gautam Buddha Nagar
UTTAR PRADESH |
9760084221
ambreen.fatima@galgotiasuniversity.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Departmental Research committee, Department of physiotherapy, School of Allied Health science, Galgotias University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J988||Other specified respiratory disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Active Cycle of Breathing Technique |
Participants will receive a structured home based pulmonary rehabilitation program using ACBT, consisting of breathing control, thoracic expansion exercises, and forced expiration techniques. The intervention will be administered for 30 minutes per day, 5 days per week, for 6 weeks, under home based supervision and periodic monitoring. This intervention aims to improve functional status, dyspnea, quality of life, psychological well being, and sleep quality in adults with asthma. |
| Comparator Agent |
Diaphragmatic Breathing Exercise |
Participants will receive a home based diaphragmatic breathing exercise program consisting of controlled deep breathing focused on diaphragmatic activation. The intervention will be administered for 30 minutes per day, 5 days per week, for 6 weeks, under home based supervision and periodic monitoring. This comparator intervention will serve as the control breathing technique to evaluate and compare its effects with ACBT on functional status, dyspnea, quality of life, depression, stress, and sleep quality. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Adults 20to45 years with physician-diagnosed asthma Asthma Control Test more than 20 controlled asthma .Willingness to participate in home-based program |
|
| ExclusionCriteria |
| Details |
COPD or other significant pulmonary diseases.
Severe cardiac, orthopedic, or neurological disorders.
Cognitive impairment or psychiatric illness requiring active treatment.
Pregnant or lactating women.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome to be assessed will be functional status, measured using the 6 Minute Walk Test (6MWT), to evaluate changes in exercise capacity and physical functional performance in adults with asthma following the home based pulmonary rehabilitation program. |
Baseline Day 1, Mid intervention assessment Week 4, Post intervention assessment Week 6, and Follow up assessment 1 month 14 days after completion of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Dyspnea severity, assessed using the mMRC scale and Borg scale
2. Quality of life, assessed using the WHOQOL BREF questionnaire
3. Depression level, assessed using the PHQ 9 scale
4. Stress level, assessed using the Perceived Stress Scale PSS 10
5. Sleep quality, assessed using the Pittsburgh Sleep Quality Index PSQI
|
Baseline Day 1, Mid intervention assessment Week 4, Post intervention assessment Week 6, and Follow up assessment 1 month 14 days after completion of intervention |
|
|
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)
|
20/03/2026 |
| 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="1"
Days="14" |
|
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 evaluates a home based pulmonary rehabilitation program using Active Cycle of Breathing Technique and diaphragmatic breathing in Indian adults with controlled asthma. The study compares their effects on functional status dyspnea quality of life depression stress and sleep quality. Sixty participants aged 20 to 45 years will be randomly allocated into two groups and receive 30 minutes of home based breathing exercises five days per week for six weeks. Outcomes will be assessed using different scales to develop a low cost scalable holistic asthma rehabilitation model for India |