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CTRI Number  CTRI/2026/02/103002 [Registered on: 04/02/2026] Trial Registered Prospectively
Last Modified On: 03/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A Study To See Whether Electrical Stimulation Improves Breathing In People With COPD 
Scientific Title of Study   Effect Of Neuromuscular Electrical Stimulation Of Diaphragm On Maximal Inspiratory Pressure, Maximal Expiratory Pressure And Quality Of Life In Chronic Obstructive Pulmonary Disease 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  JADI ROOPA 
Designation  POST GRADUATE STUDENT 
Affiliation  DURGABAI DESHMUKH HOSPITAL AND RESEARCH CENTRE 
Address  26Q7C VIDYANAGAR OSMANIA UNIVERSITY ADIKMET ROAD HYDERABAD TELANGANA

Hyderabad
TELANGANA
500044
India 
Phone  7382855372  
Fax    
Email  roopajadi30@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR SRAVANTHI PERAKAM 
Designation  Professor 
Affiliation  DURGABAI DESHMUKH HOSPITAL AND RESEARCH CENTRE 
Address  26Q7C VIDYANAGAR OSMANIA UNIVERSITY ROAD ADIKMET HYDERABAD TELANGANA

Hyderabad
TELANGANA
500044
India 
Phone  9177853034  
Fax    
Email  Sravanthi_perakam@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  DR SRAVANTHI PERAKAM 
Designation  Professor 
Affiliation  DURGABAI DESHMUKH HOSPITAL AND RESEARCH CENTRE 
Address  26Q7C VIDYANAGAR OSMANIA UNIVERSITY ROAD ADIKMET HYDERABAD TELANGANA

Hyderabad
TELANGANA
500044
India 
Phone  9177853034  
Fax    
Email  Sravanthi_perakam@yahoo.co.in  
 
Source of Monetary or Material Support  
JADI ROOPA Vidyanagar Osmania University Road Adikmet Hyderabad 500044 
 
Primary Sponsor  
Name  JADI ROOPA 
Address  Vidyanagar Osmania University Road Adikmet Hyderabad Telangana 500044 
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 JADI ROOPA  Durgabai Deshmukh Out Patient Department Of Physiotherapy  DURGABAI DESHMUKH HOSPITAL OUT PATIENT DEPARTMENT OF PHYSIOTHERAPY GROUND FLOOR BLOCK 1 26Q7C Vidyanagar Osmania University Road Adikmet Hyderabad Telangana
Hyderabad
TELANGANA 
7382855372

roopajadi30@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Durgabai Deshmukh Hospital and Research Centre  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  GROUP B Sham Stimulation  Sham Stimulation ( Neuromuscular Electrical Stimulation to Diaphragm) along with Conventional Physiotherapy that is Thoracic Mobility Exercises for three times with a rest period of 30 seconds 
Intervention  GROUP A Neuromuscular Electrical Stimulation to Diaphragm   Active Neuromuscular electrical stimulation to Diaphragm along with Conventional Physiotherapy that is Thoracic Mobility Exercises for three times with a rest period of 30 seconds 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  GOLD Classification of COPD Grade II and Grade III
Breathlessness
Patients who had not participated in rehabilitation In the past 6 months
Normal intelligence and no communication barriers
Willingness to participate  
 
ExclusionCriteria 
Details  History of recent exacerbation
Dermic injury at electrode placement site
Metallic prosthesis
Coexisting neurological conditions
Other respiratory conditions such as Pulmonary Tuberculosis Bronchial Asthma Pneumonia 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Maximal Inspiratory Pressure, Maximal Expiratory Pressure  Baseline Pre intervention and Post intervention After four weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Quality of life  Baseline Pre intervention and Post intervention After four weeks 
 
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)   16/02/2026 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  
Chronic Obstructive Pulmonary Disease (COPD) is characterized by airflow limitation and respiratory muscle dysfunction, leading to reduced inspiratory and expiratory muscle strength and impaired quality of life. Weakness of the diaphragm plays a key role in exercise intolerance and dyspnea in patients with COPD. Neuromuscular electrical stimulation (NMES) has emerged as a potential adjunctive therapy to improve muscle strength and functional outcomes.
This study aims to evaluate the effect of neuromuscular electrical stimulation of the diaphragm on maximal inspiratory pressure (MIP), maximal expiratory pressure (MEP), and quality of life in patients with COPD. This is a prospective, randomized, placebo-controlled, interventional clinical trial conducted on patients diagnosed with stable COPD. Eligible participants will be randomly allocated into two groups. The experimental group will receive diaphragm NMES along with conventional physiotherapy, while the control group will receive Sham stimulation along with conventional physiotherapy.
The intervention will be administered for three sessions per week for four weeks treatment period under supervised conditions. Outcome measures including MIP, MEP, and quality of life scores will be assessed at baseline and after completion of the intervention. The results of this study may provide evidence regarding the effectiveness of diaphragm NMES as an adjunct to conventional physiotherapy in improving respiratory muscle strength and quality of life in patients with COPD.
 
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