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

Not Applicable

Terminated

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Procedure: pulmonary rehabilitation

• Registration Number: NCT01384981
• Lead Sponsor: Schön Klinik Berchtesgadener Land

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-06-27
• Study First Submitted QC: 2011-06-28
• Study First Posted: 2011-06-29
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-03
• Last Update Posted: 2015-09-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pulmonary rehabilitation with NIV	pulmonary rehabilitation	Patients receiving nocturnal non-invasiv Ventilation during a 3-week pulmonary Rehabilitation program.
pulmonary rehabilitation without NIV	pulmonary rehabilitation	Patients receiving no nocturnal non-invasiv Ventilation during a 3-week pulmonary Rehabilitation program.

Primary Outcome Measures

Name	Time	Method
change in 6 minute walking distance	day 1 and 25	change in 6 minute walking distance from baseline to day 25

Secondary Outcome Measures

Name	Time	Method
change in quality of life (chronic respiratory questionnaire, CRQ)	day 1 and 25	change in CRQ-Score from baseline to day 25
change quality of life (Saint George´s Respiratory Questionnaire, SGRQ)	day 1 and 25	change in SGRQ-Score from baseline to day 25

Trial Locations

Locations (1)

Schön Klinik Berchtesgadener Land; 🇩🇪 Schönau am Königssee, Germany