Chronic Obstructive Pulmonary DiseaseNCT02140892
A Comparison Study of Two Respiratory Physical Therapy Methods and Standard Medical Treatment for Treating COPD Patients During Acute Exacerbation
A study testing respiratory physical therapy manual technique- Autogenic Drainage and respiratory physical therapy technique- IPV in people with Chronic Obstructive Pulmonary Disease and Chronic Bronchitis, run by Sheba Medical Center.
Trial summary
One of the main goals of the respiratory physical therapy is to help people who are suffering from accumulating of secretions in their airways and lungs. Chronic Obstructive Pulmonary Disease (COPD) patients are often hospitalized with an Acute Exacerbation of their medical condition. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Chronic Bronchitis
- What is being tested?
- respiratory physical therapy manual technique- Autogenic Drainage and respiratory physical therapy technique- IPV
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Dec 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnosis of Acute Exacerbation of COPD or Acute Exacerbation of Chronic Bronchitis
- Respiratory Rate>25
- PaCO2> 45 mmHg
- 7.35 < PH < 7.38
Who cannot join
- intubation
- apnea
- glasgow coma scale < 8
- pneumothorax
- FEV1 < 50% predicted
- Ischemic Hearth Disease
Trial locations and contacts
No sites are listed yet.
About this study
One of the main goals of the respiratory physical therapy is to help people who are suffering from accumulating of secretions in their airways and lungs.
Chronic Obstructive Pulmonary Disease (COPD) patients are often hospitalized with an Acute Exacerbation of their medical condition.
Read more
Those patients usually get only the standard medical care during the acute phase and don't get respiratory physical therapy treatment.
The study's main aim is to investigate if respiratory physical therapy treatment in addition to standard medical care during the acute phase, can improve the respiratory and medical condition and reduce hospitalization stay.
In order to do so we will compare three groups of COPD patients during acute exacerbation; two groups will get one out of two respiratory physical therapy techniques; manually or Intrapulmonary Percussive Ventilator (IPV) in addition to standard medical care and the third group will get standard medical care alone.
- Being tested
- respiratory physical therapy manual technique- Autogenic Drainage, respiratory physical therapy technique- IPV
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Bronchitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
respiratory physical therapy manual technique- Autogenic DrainageProcedure or surgery
respiratory physical therapy technique- IPVDevice
| Study group | Role | What they receive |
|---|---|---|
| respiratory physical therapy manual technique | Experimental | respiratory physical therapy manual technique- Autogenic Drainage Receives: Procedure: respiratory physical therapy manual technique- Autogenic Drainage |
| respiratory physical therapy technique- IPV | Experimental | respiratory physical therapy technique- Intrapulmonary Percussive Ventilation Receives: Device: respiratory physical therapy technique- IPV |
| standart medical care | No intervention | standard medical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
length of stay in the hospital
Measured: up to three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2014 (estimated)
- Study startJul 2014
- Primary completionJul 2015 (estimated)
- Study completionDec 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02140892
- Sponsor's protocol ID
- SHEBA-13-0697-YO-CTIL
- Status last verified
- May 2014
- First submitted
- 14 May 2014
- Last updated
- 16 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Study of Two Respiratory Physical Therapy Methods and Standard Medical Treatment for Treating COPD Patients During Acute Exacerbation
- ClinicalTrials.gov ID
- NCT02140892
- Acronym / sponsor ID
- SHEBA-13-0697-YO-CTIL
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jul 2014
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 16 May 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.
One of the main goals of the respiratory physical therapy is to help people who are suffering from accumulating of secretions in their airways and lungs.
Chronic Obstructive Pulmonary Disease (COPD) patients are often hospitalized with an Acute Exacerbation of their medical condition.
Those patients usually get only the standard medical care during the acute phase and don't get respiratory physical therapy treatment.
The study's main aim is to investigate if respiratory physical therapy treatment in addition to standard medical care during the acute phase, can improve the respiratory and medical condition and reduce hospitalization stay.
In order to do so we will compare three groups of COPD patients during acute exacerbation; two groups will get one out of two respiratory physical therapy techniques; manually or Intrapulmonary Percussive Ventilator (IPV) in addition to standard medical care and the third group will get standard medical care alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| respiratory physical therapy manual technique | Experimental | Procedure: respiratory physical therapy manual technique- Autogenic Drainagerespiratory physical therapy manual technique- Autogenic Drainage |
| respiratory physical therapy technique- IPV | Experimental | Device: respiratory physical therapy technique- IPVrespiratory physical therapy technique- Intrapulmonary Percussive Ventilation |
| standart medical care | No intervention | –standard medical care |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- clinical diagnosis of Acute Exacerbation of COPD or Acute Exacerbation of Chronic Bronchitis
- Respiratory Rate>25
- PaCO2> 45 mmHg
- 7.35 < PH < 7.38
Key exclusion criteria (6 listed)
- intubation
- apnea
- glasgow coma scale < 8
- pneumothorax
- FEV1 < 50% predicted
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 |
|---|---|---|
| respiratory physical therapy manual technique- Autogenic Drainage | Procedure or surgery | respiratory physical therapy manual technique |
| respiratory physical therapy technique- IPV | Device | respiratory physical therapy technique- IPV |
Primary outcome
length of stay in the hospital
Time frame: up to three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 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.
Questions about this trial
What is this clinical trial studying?
A study testing respiratory physical therapy manual technique- Autogenic Drainage and respiratory physical therapy technique- IPV in people with Chronic Obstructive Pulmonary Disease and Chronic Bronchitis, run by Sheba Medical Center.
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 6 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 16 May 2014. Status can change between updates, so confirm with the study contact before making plans.
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 Yaakov (kobi) Dagan, Msc. (0523694979, kobi.dagan@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
length of stay in the hospital (time frame: up to three months). 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 16 May 2014.