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

May 15, 2014 updated by: Sheba Medical Center

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
length of stay in the hospital
Time Frame: up to three months
up to three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Anticipated)

July 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

May 14, 2014

First Submitted That Met QC Criteria

May 15, 2014

First Posted (Estimate)

May 16, 2014

Study Record Updates

Last Update Posted (Estimate)

May 16, 2014

Last Update Submitted That Met QC Criteria

May 15, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-13-0697-YO-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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