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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  
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 
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  
Status 
Not Applicable 
 
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.

 
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