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A Comparison Study of Two Respiratory Physical Therapy Methods and Standard Medical Treatment for Treating COPD Patients During Acute Exacerbation

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ClinicalTrials.gov Identifier: NCT02140892
Recruitment Status : Unknown
Verified May 2014 by Sheba Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : May 16, 2014
Last Update Posted : May 16, 2014
Sponsor:
Information provided by (Responsible Party):
Sheba Medical Center

Study Description
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Brief 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.

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.


Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Chronic Bronchitis Procedure: respiratory physical therapy manual technique- Autogenic Drainage Device: respiratory physical therapy technique- IPV Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Study Start Date : July 2014
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arms and Interventions
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Arm Intervention/treatment
Experimental: respiratory physical therapy manual technique
respiratory physical therapy manual technique- Autogenic Drainage
 Procedure: respiratory physical therapy manual technique- Autogenic Drainage
Experimental: respiratory physical therapy technique- IPV
respiratory physical therapy technique- Intrapulmonary Percussive Ventilation
 Device: respiratory physical therapy technique- IPV
No Intervention: standart medical care
standard medical care


Outcome Measures
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Primary Outcome Measures :
  1. length of stay in the hospital [ Time Frame: up to three months ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • clinical diagnosis of Acute Exacerbation of COPD or Acute Exacerbation of Chronic Bronchitis
  • Respiratory Rate>25
  • PaCO2> 45 mmHg
  • 7.35 < PH < 7.38

Exclusion Criteria:

  • intubation
  • apnea
  • glasgow coma scale < 8
  • pneumothorax
  • FEV1 < 50% predicted
  • Ischemic Hearth Disease
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02140892


Contacts
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Contact: Yaakov (kobi) Dagan, Msc. 0523694979 kobi.dagan@sheba.health.gov.il

Sponsors and Collaborators
Sheba Medical Center
More Information
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Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT02140892    
Other Study ID Numbers: SHEBA-13-0697-YO-CTIL
First Posted: May 16, 2014    Key Record Dates
Last Update Posted: May 16, 2014
Last Verified: May 2014
Additional relevant MeSH terms:
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Bronchitis
Bronchitis, Chronic
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
 Respiratory Tract Diseases
Respiratory Tract Infections
Infections
Bronchial Diseases