| CTRI Number |
CTRI/2026/03/105263 [Registered on: 03/03/2026] Trial Registered Prospectively |
| Last Modified On: |
02/03/2026 |
| 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
|
SIMEOX plus chest physiotherapy versus chest physiotherapy alone for improving sputum clearance in adults hospitalized with COPD exacerbation. |
|
Scientific Title of Study
|
Effect of Simeox® as a novel airway clearance device in the management of COPD patients with acute exacerbations: A randomised 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 |
Kritika Srivastava |
| Designation |
Student, MPT 4th Semester |
| Affiliation |
Jamia Millia Islamia |
| Address |
Centre for Physiotherapy and Rehabilitation SciencesDepartment,Jamia Millia Islamia,Jamia Nagar,New Delhi 110025
South
DELHI
110025
India |
| Phone |
7268984289 |
| Fax |
|
| Email |
kritikasri143@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aqsa Mujaddadi |
| Designation |
Assistant Professor CPRS, Jamia Millia Islamia Islamia |
| Affiliation |
Jamia Millia Islamia |
| Address |
Room No 103,1st Floor,Centre for Physiotherapy and Rehabilitation Sciences,Jamia Millia Islamia, New Delhi 110025
South
DELHI
110025
India |
| Phone |
8130676908 |
| Fax |
|
| Email |
aqsamuj786@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kritika Srivastava |
| Designation |
Student, MPT 4th Semester |
| Affiliation |
Jamia Millia Islamia |
| Address |
Centre for Physiotherapy and Rehabilitation Sciences Department,Jamia Millia Islamia, New Delhi 110025
South
DELHI
110025
India |
| Phone |
7268984289 |
| Fax |
|
| Email |
kritikasri143@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Centre for Physiotherapy and Rehabilitation Sciences |
| Address |
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, New Delhi-110025 |
| Type of Sponsor |
Other [Central University] |
|
|
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 |
| Kritika Srivastava |
Metro Hospital and Heart Institute |
Room no.13,3rd floor,Metro Centre for Respiratory Diseases, Metro Hospitals and Heart Institute, Noida, Sector 11, 201301.
Gautam Buddha Nagar
UTTAR PRADESH |
7268984289
kritikasri143@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Jamia Millia Islamia |
Approved |
| Metro Ethical Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J441||Chronic obstructive pulmonary disease with (acute) exacerbation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Chest Physiotherapy (CPT) |
Chest physiotherapy five days per week on consecutive days for 14 days each session will last about 20 minutes and be delivered twice daily. |
| Intervention |
CPT and Simeox |
SIMEOX plus conventional chest physiotherapy for 14 days SIMEOX will be delivered 5 days/week on consecutive days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Adults more than or equal to 18 years old with AECOPD will be considered.
Presence of not–fully reversible airflow limitation, with an FEV1/ FVC less than 0.7 post bronchodilation measured by spirometry.
COPD patients, GOLD stage II-IV
Patients who are hospitalised for severe exacerbation of COPD experiencing worsening of dyspnoea, cough, and or sputum lasting up to 14 days, often accompanied by tachypnoea and tachycardia for duration less than 2 weeks.
Significant Sputum production.
|
|
| ExclusionCriteria |
| Details |
Patients that had under gone previous lung transplantation, required mechanical non-invasive ventilation for more than eight hours per day, had history of haemoptysis or pneumothorax in the last 12 months, were pregnant or breastfeeding.
Severe cardiac comorbidities (recent heart attack, unstable angina, uncontrolled rhythm disorders, and unstable cardiac failure) or neuromuscular disorders.
Patients who present with Asthma and Asthma-COPD overlap syndrome ACOS.
Patients who present with other respiratory conditions such as bronchiectasis, cystic fibrosis and interstitial lung diseases.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
sputum clearance
dyspnea
peak cough flow |
baseline and after 14 days intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
pulmonary function
arterial blood gases levels
functional capacity
health related quality of life
anxiety and depression |
baseline and after 14 days intervention |
|
|
Target Sample Size
|
Total Sample Size="43"
Sample Size from India="43"
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)
|
18/03/2026 |
| 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="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
|
This prospective, randomized controlled trial will evaluate whether adding the SIMEOX airway clearance device to conventional chest physiotherapy (CPT and Simeox) improves sputum clearance and clinical outcomes compared with CPT alone in adults hospitalized with acute exacerbation of COPD (GOLD II to IV). A total of 43 participants will be randomized to the two groups and will receive supervised physiotherapy twice daily for 14 days (28 sessions). The intervention group will receive SIMEOX therapy twice daily (each SIMEOX session approximately 10 minutes consisting of three cycles of 10 breaths with 45 second breaks, using frequency settings of 12 Hz or 6 Hz as tolerated and an exhalation ramp from 100% to 25%) in addition to CPT and ACBT, while the control group will receive CPT (postural drainage, percussion, vibration) combined with ACBT performed twice daily (each session approximately 20 minutes). Baseline data including sputum volume, peak cough flow rate, dyspnea, pulmonary function tests, arterial blood gases, functional capacity, health realted quality of life, Hospital Anxiety and Depression will be collected one day before intervention and post intervention measurements will be taken one day after completion of 28 sessions of training using standardized protocol. |