Effects of Non-invasive Ventilation on Rehabilitation Outcome in COPD-patients

Schön Klinik Berchtesgadener Land

Status: Terminated

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Procedure: pulmonary rehabilitation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01384981

BGL NIV

Details and patient eligibility

About

The aim of the study is to find out if nocturnal non-invasive ventilation during pulmonary rehabilitation increases exercise capacity and quality of life more than pulmonary rehabilitation alone.

Enrollment: 31 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• confirmed diagnosis of COPD in stages GOLD III/ IV
• receiving optimized medical treatment and long term oxygen therapy if needed
• patients consent to participate in this trial
• no treatment with NIV in the last 4 weeks
• treatment with NIV in the last 4 weeks due to an acute exacerbation

Exclusion criteria

• treatment with NIV in the last 4 weeks (except due to an acute exacerbation)
• Intolerance to perform NIV
• Acute exacerbation at baseline or during PR
• Hypercapnia > pCO2 55mmHg
• Inability to perform a 6 minute walking test

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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31 participants in 2 patient groups

pulmonary rehabilitation with NIV

Active Comparator group

Description:

Patients receiving nocturnal non-invasiv Ventilation during a 3-week pulmonary Rehabilitation program.

Treatment:

Procedure: pulmonary rehabilitation

pulmonary rehabilitation without NIV

Sham Comparator group

Description:

Patients receiving no nocturnal non-invasiv Ventilation during a 3-week pulmonary Rehabilitation program.

Treatment:

Procedure: pulmonary rehabilitation