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

Sponsor

Sheba Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT02140892

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

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.

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	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

75 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Study Start Date :

Jul 1, 2014

Anticipated Primary Completion Date :

Jul 1, 2015

Anticipated Study Completion Date :

Dec 1, 2015

Arms and Interventions

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

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

Primary Outcome Measures

length of stay in the hospital [up to three months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Sheba Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sheba Medical Center

ClinicalTrials.gov Identifier:

NCT02140892

Other Study ID Numbers:

SHEBA-13-0697-YO-CTIL

First Posted:

May 16, 2014

Last Update Posted:

May 16, 2014

Last Verified:

May 1, 2014

Additional relevant MeSH terms:

Bronchitis

Bronchitis, Chronic

Lung Diseases, Obstructive

Pulmonary Disease, Chronic Obstructive

Study Results

No Results Posted as of May 16, 2014