| 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
|
|
|
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
|
|
|
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. |