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CTRI Number  CTRI/2024/07/071176 [Registered on: 23/07/2024] Trial Registered Prospectively
Last Modified On: 23/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Comparing Two Different Breathing Therapies for Managing COPD: High-Frequency Chest Wall Oscillation (HFCWO) vs. Traditional Chest Physiotherapy (CPT) 
Scientific Title of Study   Comparative Analysis of High-Frequency Chest Wall Oscillation (HFCWO) vs. Traditional Chest Physiotherapy (CPT) in the Management of COPD 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pankaj Singh 
Designation  Phd Scholar,Galgotias University 
Affiliation  Galgotias University 
Address  Room no - 305, Department of physiotherapy, Galgotias University

Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  9810604426  
Fax    
Email  drpsingh9@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Sajjad Alam 
Designation  Professor, Galgotias University 
Affiliation  Galgotias University 
Address  Room No - 305, Department Of Physiotherapy, Galgotias University


UTTAR PRADESH
201310
India 
Phone    
Fax    
Email  sajjad.alam@galgotiasuniversity.edu.in  
 
Details of Contact Person
Public Query
 
Name  Pankaj Singh 
Designation  Phd Scholar,Galgotias University 
Affiliation  Galgotias University 
Address  Room No - 305, Department Of Physiotherapy, Galgotias University


UTTAR PRADESH
201310
India 
Phone  9810604426  
Fax    
Email  drpsingh9@gmail.com  
 
Source of Monetary or Material Support  
GALGOTIAS UNIVERSITY,Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh 203201 
 
Primary Sponsor  
Name  NO 
Address  NO 
Type of Sponsor  Other [] 
 
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 
PK SINGH  Navin Hospital  NH-3, 1st St, Pocket F, Block F, Sector Alpha II, Greater Noida, Brahmpur Rajraula Urf Nawada, Uttar Pradesh 201308
Gautam Buddha Nagar
UTTAR PRADESH 
9810604426

drpsingh9@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Navin Hospital  Approved 
SCHOOL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J00-J99||Diseases of the respiratory system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  High-Frequency Chest Wall Oscillation (HFCWO)   • High-Frequency Chest Wall Oscillation (HFCWO) sessions will be conducted thrice weekly for a duration of 4 weeks. • Each session will last 20 minutes, with adjustments based on patient tolerance. • Standardized techniques and settings will be employed using an approved HFCWO device. • Peak pressures of ≈29 cmH2O at 10 Hz for setting 6 up to a maximal peak pressure of ≈45 cmH2O at 15 Hz for setting 10 when the garment perfectly fits on the thorax of the patient.  
Comparator Agent  Traditional Chest Physiotherapy (CPT)  • Traditional Chest Physiotherapy (CPT) sessions will be conducted thrice weekly for 4 weeks. • Sessions will include chest percussion, vibration, and postural drainage techniques. Each session will last 20 minutes, with adjustments based on patient tolerance 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1.Confirmed COPD Diagnosis: Participants must have a confirmed diagnosis of COPD.
2.Specific Age Range: 18 Years to 45 Years.
3.Stable Disease State: Participants should be in a stable COPD state without recent exacerbations.
4.Informed Consent: Ability to provide informed consent for voluntary participation.
5.Adherence to Treatment Protocols: Willingness to comply with HFCWO and CPT treatment protocols.
6.Ability to Use HFCWO Device or Receive CPT: Physical capability to use HFCWO or receive CPT.
7.Stable Medication Regimen: On a stable COPD medication regimen with documented changes.
8.Compliance with Study Visits: Commitment to attending scheduled visits and assessments.
9.No Contraindications: Absence of contraindications to HFCWO or CPT.
10.Language Proficiency: Proficient in the language(s) used for study communication and assessments.
 
 
ExclusionCriteria 
Details  1.Unstable Medical Conditions: Exclusion of individuals with acute medical conditions other than COPD.
2.Severe Cognitive Impairment: Exclusion of those with severe cognitive impairment affecting decision-making.
3.Recent Exacerbations: Exclusion of participants with recent COPD exacerbations.
4.Severe Respiratory Distress: Exclusion of individuals in severe respiratory distress or requiring urgent medical intervention.
5.Contraindications to HFCWO or CPT: Exclusion of participants with contraindications to HFCWO or CPT.
6.Inability to Use HFCWO or Receive CPT: Exclusion of individuals physically unable to use HFCWO or receive CPT.
7.Pregnancy: Exclusion of pregnant individuals for safety reasons.
8.Non-compliance with Study Requirements: Exclusion of those unwilling or unable to comply with study protocols.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement in forced expiratory volume in one second (FEV1)   baseline, 4 weeks & 8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Frequency and duration of hospitalizations due to COPD exacerbations.
Change in peak expiratory flow rate (PEFR) or other measures of lung function.
Adverse events or complications related to treatment.
Patient adherence to treatment regimen.
Change in respiratory muscle strength. 
2 WEEKS,4 WEEKS 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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   Phase 2 
Date of First Enrollment (India)   30/08/2024 
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 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  

The study will commence with participant recruitment, emphasizing individuals diagnosed with Chronic Obstructive Pulmonary Disease (COPD) who meet the predefined inclusion criteria. After obtaining informed consent, participants will be randomized into two groups: one receiving High-Frequency Chest Wall Oscillation (HFCWO) and the other Traditional Chest Physiotherapy (CPT). A baseline assessment of clinical parameters, respiratory function, and patient-reported outcomes will be conducted. Throughout the intervention period, participants will undergo the assigned therapy according to prescribed protocols.

Regular follow-up visits will assess treatment adherence, monitor potential adverse events, and collect data on relevant physiological and clinical parameters. The study will also incorporate subgroup analyses to explore potential variations in treatment response based on factors such as disease severity or comorbidities. The research team will employ standardized tools to evaluate patient-reported outcomes, ensuring a comprehensive understanding of subjective experiences.

Upon completion of the intervention period, a final assessment will be conducted to compare the effectiveness of HFCWO and CPT in managing COPD. Statistical analyses will be employed to discern any significant differences in clinical outcomes, physiological impact, and patient-reported measures between the two groups. The study’s findings aim to contribute evidence-based insights into the comparative effectiveness of HFCWO and CPT, informing future clinical practices for optimizing respiratory care in individuals with COPD.

Participants in both groups, undergoing the comparative study of High-Frequency Chest Wall Oscillation (HFCWO) and Traditional Chest Physiotherapy (CPT) for the management of Chronic Obstructive Pulmonary Disease (COPD), will receive the following interventions:

HFCWO Group:

Participants in this group will undergo High-Frequency Chest Wall Oscillation using a device connected to an inflatable vest. The vest delivers oscillations or vibrations to the chest wall, facilitating mucus mobilization and airway clearance. Individuals will be trained on proper device usage and encouraged to perform HFCWO sessions as prescribed by healthcare providers.

CPT Group:

Participants assigned to the Traditional Chest Physiotherapy (CPT) group will receive manual chest physiotherapy administered by trained healthcare professionals. This may include percussion, vibration, and postural drainage techniques to assist in mobilizing and clearing respiratory secretions. Participants will attend scheduled sessions where CPT will be applied, and the techniques may be tailored based on individual patient needs and response.

 
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