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

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

• Study Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

3

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	up to three months

Collaborators and Investigators

• Sponsor: Sheba Medical Center

Study record dates

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: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Bronchitis; Bronchitis, Chronic
• Other Study ID Numbers: SHEBA-13-0697-YO-CTIL