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

Primary Purpose

Chronic Obstructive Pulmonary Disease, Chronic Bronchitis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
respiratory physical therapy manual technique- Autogenic Drainage
respiratory physical therapy technique- IPV
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    respiratory physical therapy manual technique

    respiratory physical therapy technique- IPV

    standart medical care

    Arm Description

    respiratory physical therapy manual technique- Autogenic Drainage

    respiratory physical therapy technique- Intrapulmonary Percussive Ventilation

    standard medical care

    Outcomes

    Primary Outcome Measures

    length of stay in the hospital

    Secondary Outcome Measures

    Full Information

    First Posted
    May 14, 2014
    Last Updated
    May 15, 2014
    Sponsor
    Sheba Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02140892
    Brief Title
    A Comparison Study of Two Respiratory Physical Therapy Methods and Standard Medical Treatment for Treating COPD Patients During Acute Exacerbation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2014
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2014 (undefined)
    Primary Completion Date
    July 2015 (Anticipated)
    Study Completion Date
    December 2015 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Sheba Medical Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Obstructive Pulmonary Disease, Chronic Bronchitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    75 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    respiratory physical therapy manual technique
    Arm Type
    Experimental
    Arm Description
    respiratory physical therapy manual technique- Autogenic Drainage
    Arm Title
    respiratory physical therapy technique- IPV
    Arm Type
    Experimental
    Arm Description
    respiratory physical therapy technique- Intrapulmonary Percussive Ventilation
    Arm Title
    standart medical care
    Arm Type
    No Intervention
    Arm Description
    standard medical care
    Intervention Type
    Procedure
    Intervention Name(s)
    respiratory physical therapy manual technique- Autogenic Drainage
    Intervention Type
    Device
    Intervention Name(s)
    respiratory physical therapy technique- IPV
    Primary Outcome Measure Information:
    Title
    length of stay in the hospital
    Time Frame
    up to three months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yaakov (kobi) Dagan, Msc.
    Phone
    0523694979
    Email
    kobi.dagan@sheba.health.gov.il

    12. IPD Sharing Statement

    Learn more about this trial

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

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