Chronic Obstructive Pulmonary DiseaseNCT02249455
Effectiveness of Acapella and ELTGOL Technique to Promote Airway Clearance in COPD:a Comparative Study
A study testing Acapella, ELTGOL and conventional physiotherapy in people with Chronic Obstructive Pulmonary Disease, run by PSG College of Physiotherapy at 1 site in India.
Trial summary
To compare the efficacy of acapella and expiration against open glottis (ELTGOL) technique in promoting airway clearance of chronic obstructive pulmonary disease (COPD) patients Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Acapella, ELTGOL and conventional physiotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- Jul 2014to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild copd
- Moderate copd
- Patient able to sustain expiratory flow greater than 15l/min
- Patient expectorate more than 25.-30ml
Who cannot join
- Severe copd
- Peripheral oxygen saturation lower than 85%
- Rr>35breaths/min
- Current acute chest pain
- Recent history of haemoptysis
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Steffi Varghese
Coimbatore, Tamil Nadu, 641004
mahesh, mpt, 04222570170
shanmugapriya, mpt, 04222570170
About this study
Official title: Effectiveness of Acapella and ELTGOL (Expiration in Lateral Position With Open Glottis)Technique to Promote Airway Clearance in COPD Patients:a Comparative Study
To compare the efficacy of acapella and expiration against open glottis (ELTGOL) technique in promoting airway clearance of chronic obstructive pulmonary disease (COPD) patients
Read the detailed description
This study is carried out to determine the effectiveness of acapella and expiration in lateral position with open glottis to clear the secretion in COPD patients. The sessions will be carried twice daily for twenty minutes. The outcome measures are values of pre and post intervention fev1/fvc and breathlessness cough sputum scale. Duration of the study will be for five days.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Acapella, ELTGOL, conventional physiotherapy
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcapellaDevice
Also called ACAPELLA DHD
Treatment time for 20 min twice daily
ELTGOLOther
Also called Expiration in lateral position with open glottis for twenty min twice daily.
ELTGOL technique 20 min twice daily
conventional physiotherapyOther
Conventional physiotherapy was given twice daily for 20 min
| Study group | Role | What they receive |
|---|---|---|
| Acapella | Experimental | Acapella is given to the patients twice daily for 20 min. Receives: Device: Acapella |
| ELTGOL | Experimental | Expiration with open glottis in lateral position is done twice daily for 20 min Receives: Other: ELTGOL |
| conventional physiotherapy | Active comparator | Conventional physiotherapy like breathing exercise, active coughing, chest mobilisation was encouraged twice daily for 20 min. Receives: Other: conventional physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Force expiratory volume in one second
Fev1/fvc values were noted after pre and post intervention of airway clearance manoeuver
Measured: change from baseline at 30 minutes
Secondary outcomes (1)
Change in breathlessness cough sputum score
Bcss scale was interviewed to the patient on first day and the fifth day. The changes were noted.
Measured: change from baseline at 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2014 (estimated)
- Study completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PSG College of Physiotherapy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, STEFFI VARGHESE P, PSG College of Physiotherapy
- Investigators
- steffi varghese, mpt, Principal investigator, psg ims&r
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02249455
- Sponsor's protocol ID
- 14\305
- Status last verified
- Sep 2014
- First submitted
- 4 Sep 2014
- Last updated
- 25 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Acapella and ELTGOL (Expiration in Lateral Position With Open Glottis)Technique to Promote Airway Clearance in COPD Patients:a Comparative Study
- ClinicalTrials.gov ID
- NCT02249455
- Acronym / sponsor ID
- 14\305
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- PSG College of PhysiotherapyUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 25 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the efficacy of acapella and expiration against open glottis (ELTGOL) technique in promoting airway clearance of chronic obstructive pulmonary disease (COPD) patients
Detailed description
This study is carried out to determine the effectiveness of acapella and expiration in lateral position with open glottis to clear the secretion in COPD patients. The sessions will be carried twice daily for twenty minutes. The outcome measures are values of pre and post intervention fev1/fvc and breathlessness cough sputum scale. Duration of the study will be for five days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acapella | Experimental | Device: AcapellaAcapella is given to the patients twice daily for 20 min. |
| ELTGOL | Experimental | Other: ELTGOLExpiration with open glottis in lateral position is done twice daily for 20 min |
| conventional physiotherapy | Active comparator | Other: conventional physiotherapyConventional physiotherapy like breathing exercise, active coughing, chest mobilisation was encouraged twice daily for 20 min. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Mild copd
- Moderate copd
- Patient able to sustain expiratory flow greater than 15l/min
- Patient expectorate more than 25.-30ml
Key exclusion criteria (5 listed)
- Severe copd
- Peripheral oxygen saturation lower than 85%
- Rr>35breaths/min
- Current acute chest pain
- Recent history of haemoptysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcapellaAlso: ACAPELLA DHDTreatment time for 20 min twice daily | Device | Acapella |
| ELTGOLAlso: Expiration in lateral position with open glottis for twenty min twice daily.ELTGOL technique 20 min twice daily | Other | ELTGOL |
| conventional physiotherapyConventional physiotherapy was given twice daily for 20 min | Other | conventional physiotherapy |
Primary outcome
Change in Force expiratory volume in one second
Time frame: change from baseline at 30 minutes
Fev1/fvc values were noted after pre and post intervention of airway clearance manoeuver
1 secondary outcome
Change in breathlessness cough sputum score
Time frame: change from baseline at 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
steffi varghese, mpt principal investigator
psg ims&r
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acapella, ELTGOL and conventional physiotherapy in people with Chronic Obstructive Pulmonary Disease, run by PSG College of Physiotherapy at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact steffi varghese, mpt (9677465724, steffivarghesep@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Force expiratory volume in one second (time frame: change from baseline at 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2014.