| 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
|
|
|
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
|
|
|
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. |