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

NCT02140892 | Unknown

• 1 other identifier: SHEBA-13-0697-YO-CTIL
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Obstructive Pulmonary Disease; Chronic Bronchitis

Outcome Measures

Primary Outcomes (1)

• length of stay in the hospital

  up to three months

Study Arms (3)

respiratory physical therapy manual technique

EXPERIMENTAL

respiratory physical therapy manual technique- Autogenic Drainage

Procedure: respiratory physical therapy manual technique- Autogenic Drainage

respiratory physical therapy technique- IPV

EXPERIMENTAL

respiratory physical therapy technique- Intrapulmonary Percussive Ventilation

Device: respiratory physical therapy technique- IPV

standart medical care

NO INTERVENTION

standard medical care

Interventions

respiratory physical therapy manual technique- Autogenic Drainage PROCEDURE

respiratory physical therapy manual technique

respiratory physical therapy technique- IPV DEVICE

respiratory physical therapy technique- IPV

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• clinical diagnosis of Acute Exacerbation of COPD or Acute Exacerbation of Chronic Bronchitis
• Respiratory Rate\>25
• PaCO2\> 45 mmHg
• \< PH \< 7.38

You may not qualify if:

• intubation
• apnea
• glasgow coma scale \< 8
• pneumothorax
• FEV1 \< 50% predicted
• Ischemic Hearth Disease

Sponsors & Collaborators

• Sheba Medical Center: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Bronchitis, Chronic

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases

Central Study Contacts

Yaakov (kobi) Dagan, Msc.

CONTACT

0523694979; kobi.dagan@sheba.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2014
• First Posted: May 16, 2014
• Study Start: July 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 16, 2014

Record last verified: 2014-05