| CTRI Number |
CTRI/2025/12/098860 [Registered on: 11/12/2025] Trial Registered Prospectively |
| Last Modified On: |
11/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study to Compare Two Breathing Exercise Methods to Improve Lung Function and Quality of Life in COPD Patients |
|
Scientific Title of Study
|
Comparative Study on the Effect of Digital Interventional Expiratory Breath Training and Conventional Expiratory Training Devices (Powerbreath Medic) in Enhancing Functional Lung Capacity and Quality of Life in COPD Patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
K Palanibalan |
| Designation |
Research Scholar |
| Affiliation |
Faculty of Physiotherapy, Dr. M.G.R. Educational and Research Institute |
| Address |
Room No 2,Faculty of Physiotherapy, Dr. M.G.R. Educational and Research Institute, Velappanchavadi, Chennai
Chennai TAMIL NADU 600077 India |
| Phone |
9842799767 |
| Fax |
|
| Email |
kpbalan_pt2006@yahoo.com |
|
Details of Contact Person Scientific Query
|
| Name |
S Ramachandran |
| Designation |
Professor |
| Affiliation |
Faculty of Physiotherapy, Dr. M.G.R. Educational and Research Institute |
| Address |
Room No 2,Faculty of Physiotherapy, Dr. M.G.R. Educational and Research Institute, Velappanchavadi, Chennai
Chennai TAMIL NADU 600077 India |
| Phone |
9841075381 |
| Fax |
|
| Email |
ramachandran.physio@drmgrdu.ac.in |
|
Details of Contact Person Public Query
|
| Name |
S Ramachandran |
| Designation |
Professor |
| Affiliation |
Faculty of Physiotherapy, Dr. M.G.R. Educational and Research Institute |
| Address |
Room no 3,Faculty of Physiotherapy, Dr. M.G.R. Educational and Research Institute, Velappanchavadi, Chennai
Chennai TAMIL NADU 600077 India |
| Phone |
9841075381 |
| Fax |
|
| Email |
ramachandran.physio@drmgrdu.ac.in |
|
|
Source of Monetary or Material Support
|
| Faculty of Physiotherapy, Dr. M.G.R. Educational and Research Institute. |
|
|
Primary Sponsor
|
| Name |
K Palanibalan |
| Address |
Faculty of Physiotherapy, Dr. M.G.R. Educational and Research Institute, Poonamalle High Road Velappanchavadi, Chennai, Tamilnadu - 600077, India |
| Type of Sponsor |
Other [Self] |
|
|
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 K Palanibalan |
Faculty of Physiotherapy, A.C.S. Medical College and Hospital |
Faculty of Physiotherapy, A.C.S. Medical College and Hospital Poonamalle High Road (Chennai – Bangalore Highway – NH4) Velappanchavadi - 600077
Chennai Chennai TAMIL NADU |
9842799767
kpbalan_pt2006@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| A.C.S. Medical College Hospital A Constituent Unit of Dr. M.G.R. Educational and Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Incentive Spirometer and pursed lip breathing exercise |
Conventional Physiotherapy exercise utilizing Spirometer and pursed lip breathing exercise - 30 minutes / day for 3 days a week for 12 weeks |
| Intervention |
Pneumocontrol Application and POWERBREATHE Medic Device |
Digital Interventional Breathing employing the Pneumocontrol Application - 30 minutes / day for 3 days a week for 12 weeks
Expiratory Breath training using the POWERBREATHE Medic Device - 30 minutes / day for 3 days a week for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with clinically diagnosed COPD
Subjects in the Age Group Range of 40 – 50 years
Both male and female subjects
Mild to moderate Airway obstruction with Fev1 / Fvc Ratio - 60 to 70 %
Mild to Moderate COPD as per GOLD severity grading
|
|
| ExclusionCriteria |
| Details |
Subjects below the age of 40 and above 50 years
Subjects with any Active respiratory infection
Subjects with Restrictive Airway Disease and chest wall deformities
Subjects with Active Tuberculosis Infection
Subjects with Bronchial asthma and Bronchiectasis
Subjects with Recent Acute Myocardial Infarction (within 1 Month)
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Dyspnea assessment
Exiratory Flow |
Baseline
3 weeks
6 weeks
9 weeks
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Recurrence of exacerbation episodes
Quality of Life |
baseline
3 weeks
6 weeks
9 weeks
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="138" Sample Size from India="138"
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)
|
24/12/2025 |
| 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="1" Months="0" 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 study is designed to investigate and compare the therapeutic effectiveness of digital interventional expiratory breath training versus conventional expiratory training using the PowerBreathe Medic device in improving functional lung capacity and quality of life among patients with clinically diagnosed Chronic Obstructive Pulmonary Disease (COPD). The primary objective is to determine the comparative efficacy of these two expiratory training approaches in optimizing pulmonary rehabilitation outcomes within this patient population. Furthermore, the study aims to evaluate the specific effects of digital interventional expiratory breath training on reducing dyspnea and enhancing expiratory muscle strength, as well as to assess its relative advantages over conventional expiratory devices in decreasing lung hyperinflation. The study also seeks to examine patient compliance and engagement associated with each intervention to better understand adherence and usability in a clinical rehabilitation setting. Primary outcome measures will include comprehensive pulmonary function assessments, specifically functional lung capacity and health-related quality of life using validated outcome measures. Secondary outcomes will involve the evaluation of dyspnea severity, improvements in expiratory muscle strength, reduction in lung hyperinflation, and assessment of patient compliance and engagement across both intervention groups. The findings from this study are expected to provide evidence-based insights to guide clinicians in selecting the most effective expiratory training modality for tailored pulmonary rehabilitation programs, thereby contributing to improved clinical outcomes and enhanced quality of life for individuals with COPD. |