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Clinical Trials/NCT01384981
NCT01384981
Terminated
Not Applicable

Effects of Non-invasive Ventilation on Exercise Capacity and Quality of Life in COPD-patients GOLD III/IV

Schön Klinik Berchtesgadener Land1 site in 1 country31 target enrollmentJanuary 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Obstructive Pulmonary Disease
Sponsor
Schön Klinik Berchtesgadener Land
Enrollment
31
Locations
1
Primary Endpoint
change in 6 minute walking distance
Status
Terminated
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2011
End Date
September 2013
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Klaus Kenn

Dr. med Klaus Kenn, Head physician

Schön Klinik Berchtesgadener Land

Eligibility Criteria

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

Outcomes

Primary Outcomes

change in 6 minute walking distance

Time Frame: day 1 and 25

change in 6 minute walking distance from baseline to day 25

Secondary Outcomes

  • change quality of life (Saint George´s Respiratory Questionnaire, SGRQ)(day 1 and 25)
  • change in quality of life (chronic respiratory questionnaire, CRQ)(day 1 and 25)

Study Sites (1)

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