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CTRI Number  CTRI/2025/04/084816 [Registered on: 15/04/2025] Trial Registered Prospectively
Last Modified On: 11/04/2025
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   Comparing Quake And RC-Cornet PLUS Devices With Chest Physiotherapy on Sputum Volume, Pulmonary Function And Quality Of Life in Pneumonia: A Randomized Controlled Trial  
Scientific Title of Study   Comparative Analysis Of Quake Versus RC Cornet Plus With Chest Physiotherapy On Sputum Volume Pulmonary Function And Quality Of Life in Pneumonia A Randomized Comparative study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sakshi Shankarrao Waghmare 
Designation  Junior Resident 
Affiliation  Ravi Nair Physiotherapy College  
Address  Cardiorespiratory department Ravi Nair Physiotherapy College Datta Meghe Institute of Higher Education and Research Sawangi Meghe Wardha maharashtra india 442001

Wardha
MAHARASHTRA
442001
India 
Phone  9881842761  
Fax    
Email  waghmaresakku26@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vishnu Vardhan 
Designation  Professor 
Affiliation  Ravi Nair Physiotherapy College  
Address  Cardiorespiratory department Ravi Nair Physiotherapy College Datta Meghe Institute of Higher Education and Research Sawangi Meghe Wardha maharashtra india 442001

Wardha
MAHARASHTRA
442001
India 
Phone  8379917421  
Fax    
Email  vishnu.vardhan@dmiher.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Sakshi Shankarrao Waghmare 
Designation  Junior Resident 
Affiliation  Ravi Nair Physiotherapy College 
Address  Cardiorespiratory department Ravi Nair Physiotherapy College Datta Meghe Institute of Higher Education and Research Sawangi Meghe Wardha maharashtra india 442001

Wardha
MAHARASHTRA
442001
India 
Phone  9881842761  
Fax    
Email  waghmaresakku26@gmail.com  
 
Source of Monetary or Material Support  
Ravi Nair Physiotherapy College DMIHER gsawani meghe wardha maharashtra india 442001 
 
Primary Sponsor  
Name  Ravi Nair Physiotherapy College 
Address  Ravi Nair Physiotherapy College DMIHER Sawangi Meghe Wardha maharshtra india 442001 
Type of Sponsor  Research institution and hospital 
 
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 Sakshi Shankarrao Waghmare  Aacharya Vinoba Bhave Rural Hospital  Respiratory ward no. 37 Aacharya Vinoba Bhave Rural Hospital DMIHER Sawangi Meghe Wardha Maharashta India 442001
Wardha
MAHARASHTRA 		 9881842761

waghmaresakku26@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Datta Meghe Institute of Higher Education and Research (DU)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J09-J18||Influenza and pneumonia, (2) ICD-10 Condition: J189||Pneumonia, unspecified organism,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Physiotherapy  Chest Physiotherapy daily for 15-20 minutes a week 
Intervention  RC-Cornet PLUS along with chest physiotherapy on sputum volume, pulmonary function and quality of life in Pneumonia.  patients will be taught to put the mouthpiece and seal the lips around it. a deep breath and hold it for 2 to 3 seconds. Ask the patient to exhale actively but gently through the device, ensuring that the duration of exhalation is 3 to 4 times longer than inhalation. subjects will also receive chest physiotherapy daily for 15-20 minutes a week which includes exercises to improve functional capacity and early ambulation as well as breathing exercises, thoracic expansion exercises, active cycle of breathing exercise. 
Intervention  the effectiveness Quake along with chest physiotherapy on sputum volume, pulmonary function and quality of life in Pneumonia   The subject will be asked to hold the Quake in mouth, sealing their lips around the mouthpiece and asked to inhale deeply, then complete exhalation while rotating the handle at a comfortable speed.subjects will also receive chest physiotherapy daily for 15-20 minutes a week which includes exercises to improve functional capacity and early ambulation as well as breathing exercises, thoracic expansion exercises, active cycle of breathing exercise for 2 weeks.  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Both male and female subjects diagnosed with stages III and IV Pneumonia
Age 40-70 years
Subjects who will sign the informed consent form
Dyspnea Grade 1 and 2 ATS
 
 
ExclusionCriteria 
Details  Haemodynamically unstable subjects
Mentally unstable subjects
Un co-operative subjects
Other Cardiovascular, Respiratory and neurological diseases
Rib fractures, chest trauma and thoracic vertebral fracture
 
 
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 volume
Pulmonary function test
HRQOL-14 Scale 		 Baseline
2 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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)   30/04/2025 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [waghmaresakku26@gmail.com].

  6. For how long will this data be available start date provided 01-09-2025 and end date provided 01-09-2028?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Pneumonia is one of the most significant causes of respiratory morbidity. Pneumonia often results in increased mucus production, which can obstruct airways and impair gas exchange. Stagnant secretions create a medium for bacterial growth, increasing the risk of complications like abscess formation or chronic infections. Airway clearance devices such as Quake and RC-Cornet PLUS help to mobilize secretions, improving airway obstruction and facilitating easier removal of mucus. ACD can reduce bacterial load by mucus clearance, improved oxygenation, reduce work of breathing and better pulmonary function in pneumonia subjects. Early and effective airway management can reduce the duration of hospital stays. ACD offers a non-invasive, drug-free option for managing secretions. Quake and RC-Cornet PLUS device seem to be flow dependent devices. The subjects can determine the optimal personal pressure and flow characteristics by turning the mouthpiece.

Conducting a study to compare the Quake and RC-Cornet PLUS is necessary to address this gap in the literature and provide evidence-based recommendations for clinicians. By evaluating the impact of these devices on sputum volume, pulmonary functions and quality of life, this study aims to determine which device offers superior clinical benefits for pneumonia subjects

 
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