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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2014 by Sheba Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT02140892
First received: May 14, 2014
Last updated: May 15, 2014
Last verified: May 2014
  Purpose

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 Intervention
Chronic Obstructive Pulmonary Disease
Chronic Bronchitis
Procedure: respiratory physical therapy manual technique- Autogenic Drainage
Device: respiratory physical therapy technique- IPV

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

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

Estimated Enrollment: 75
Study Start Date: July 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02140892

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

Sponsors and Collaborators
Sheba Medical Center
  More Information

Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT02140892     History of Changes
Other Study ID Numbers: SHEBA-13-0697-YO-CTIL
Study First Received: May 14, 2014
Last Updated: May 15, 2014

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Bronchitis
Bronchitis, Chronic
Respiratory Tract Diseases
Bronchial Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on May 25, 2017