| CTRI Number |
CTRI/2017/06/008730 [Registered on: 01/06/2017] Trial Registered Retrospectively |
| Last Modified On: |
29/03/2017 |
| 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
|
A comparative study between two techniques to improve airway clearance in patients with Chronic Obstructive Pulmonary Disease |
|
Scientific Title of Study
|
Comparison of Lung flute and Threshold PEP for airway clearance in Chronic Obstructive Pulmonary Disease patients: A Randomized Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms Fernandes Orein Lawrence |
| Designation |
Post Graduate Student (MPT) |
| Affiliation |
Father Muller Medical College |
| Address |
Department of Physiotherapy, Father Muller Medical College, Mangalore
Dakshina Kannada KARNATAKA 575002 India |
| Phone |
8861495310 |
| Fax |
|
| Email |
oreinfernandes@yahoo.com |
|
Details of Contact Person Scientific Query
|
| Name |
Mrs Cherishma DSilva |
| Designation |
Assistant Professor |
| Affiliation |
Father Muller Medical College |
| Address |
Department of Physiotherapy, Father Muller Medical College, Mangalore
Dakshina Kannada KARNATAKA 575002 India |
| Phone |
08242238290 |
| Fax |
|
| Email |
cheri8585@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Ms Fernandes Orein Lawrence |
| Designation |
Post Graduate Student (MPT) |
| Affiliation |
Father Muller Medical College |
| Address |
Department of Physiotherapy, Father Muller Medical College, Mangalore
Dakshina Kannada KARNATAKA 575002 India |
| Phone |
8861495310 |
| Fax |
|
| Email |
oreinfernandes@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Ms Fernandes Orein Lawrence, Department of Physiotherapy, Father Muller Medical College, Kankanady, Mangalore |
|
|
Primary Sponsor
|
| Name |
Ms Fernandes Orein Lawrence |
| Address |
Department of Physiotherapy, Father Muller Medical College, Mangalore-575002 |
| Type of Sponsor |
Other [[Self Sponsered]] |
|
|
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 |
| Ms Fernandes Orein Lawrence |
Father Muller Medical College Hospital |
Department of Physiotherapy, R Ward, 3rd Floor, Father Muller Medical College, Mangalore-575002 Dakshina Kannada KARNATAKA |
8861495310
oreinfernandes@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Chronic Obstructive Pulmonary Disease (COPD), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lung Flute |
Subjects will be instructed to blow twice in to the device vigorously enough to make the reed oscillate, followed by 5 normal breaths.
10 repetitions per set, followed by 3 huff coughs, 2 sets per session, 1 session per day, 30 minutes, for 6 days.
Treatment will be stopped at the end of a 6 day session |
| Comparator Agent |
Threshold PEP |
Subjects will be instructed to slowly inspire to vital capacity and then hold their breath for about 3 seconds.
Then slowly exhale through the mouth piece with the fixed orifice resistor set to create expiratory pressure resistance between10-20 cm H20.
20 repetitions per set, followed by huff or forced exhalation, periods of relaxation and breathing control (2 minutes), 2 sets per session,1 session per day, 30 minutes, for 6 days.
Treatment will be stopped at the end of a 6 day session |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Female |
| Details |
Presence of airflow obstruction by spirometry (GOLD stage 2-4) |
|
| ExclusionCriteria |
| Details |
Active tuberculosis patients;
Patients with emphysematous bullae;
History of cough syncope;
Patients undergone abdominal, thoracic or cardiac surgeries in the last 6 months;
Pregnant women;
Un-cooperative patients |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quantity of sputum |
Total quantity of sputum in 6 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pulmonary Functions- Parameters (FVC, FEV1, FEV1/FVC ratio, PEFR) |
Difference in Pulmonary Functions after 6 days |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/02/2016 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Chronic Obstructive Pulmonary Disease (COPD) is characterized
by mucus hypersecretion and impaired mucociliary clearance, and significantly contributes
to the morbidity and mortality of this disease. According to World
Health Organization, 5% of all deaths globally occurred due to COPD in 2005 and
it is estimated to be the third leading cause of death by 2030. In this condition,
patients complain of chronic symptoms of cough, sputum production, shortness of
breath, and/or wheezing.
Currently available mucolytics and
expectorants are not proven to be effective in COPD. The available
evidence indicates that Active Breathing Techniques such as Active Cycle of Breathing
Techniques (ACBT), Autogenic Drainage and Forced Expiration, can be effective in
treatment of COPD. The Passive Techniques such as Postural Drainage, Percussion
as well as Supporting Techniques such as Intrapulmonary Percussive Ventilation,
PEP and Non-Invasive Ventilation have little evidence due to the small number
of studies.
The Lung Flute is a new, Food and
Drug Administration (FDA) approved Oscillatory Positive Expiratory Pressure
(OPEP) device which has been shown to be effective in inducing sputum when used
once. It produces a low frequency acoustic wave with an exhalation vigorous enough
to make the reed oscillate thereby increasing mucociliary clearance. Threshold
PEP has a flow independent one way valve, ensuring consistent resistance
through adjustable specific pressure settings (in cm H2O) set by healthcare
professionals. When patients exhale through it, the resistive load creates
positive pressure that helps open the airways and allows mucus to be expelled
during “huff†coughing (Forced Expiratory Technique) thus helping in airway
clearance, bronchial hygiene and can be used as an alternate to Chest Physical
Therapy.
Current choices for treatment of
mucus hypersecretion are few with limited data to support their effectiveness
in COPD. Although Lung Flute and Threshold PEP have found to be effective in
airway clearance in COPD patients, no previous studies have been done comparing
the two devices to know which is more effective for airway clearance in this
disease. Hence there is a need of this study to compare the two devices. |