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

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ClinicalTrials.gov Identifier: NCT01384981
Recruitment Status : Terminated (major problems in recruiting patients due to very strict inclusion criteria)
First Posted : June 29, 2011
Last Update Posted : September 4, 2015
Sponsor:
Collaborator:
ResMed
Information provided by (Responsible Party):
Klaus Kenn, Klinikum Berchtesgadener Land der Schön-Kliniken

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Procedure: pulmonary rehabilitation Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Non-invasive Ventilation on Exercise Capacity and Quality of Life in COPD-patients GOLD III/IV
Study Start Date : January 2011
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Active Comparator: pulmonary rehabilitation with NIV
Patients receiving nocturnal non-invasiv Ventilation during a 3-week pulmonary Rehabilitation program.
Procedure: pulmonary rehabilitation
Sham Comparator: pulmonary rehabilitation without NIV
Patients receiving no nocturnal non-invasiv Ventilation during a 3-week pulmonary Rehabilitation program.
Procedure: pulmonary rehabilitation



Primary Outcome Measures :
  1. change in 6 minute walking distance [ Time Frame: day 1 and 25 ]
    change in 6 minute walking distance from baseline to day 25


Secondary Outcome Measures :
  1. change in quality of life (chronic respiratory questionnaire, CRQ) [ Time Frame: day 1 and 25 ]
    change in CRQ-Score from baseline to day 25

  2. change quality of life (Saint George´s Respiratory Questionnaire, SGRQ) [ Time Frame: day 1 and 25 ]
    change in SGRQ-Score from baseline to day 25



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01384981


Locations
Germany
Schön Klinik Berchtesgadener Land
Schönau am Königssee, Germany, 83471
Sponsors and Collaborators
Klinikum Berchtesgadener Land der Schön-Kliniken
ResMed

Responsible Party: Klaus Kenn, Dr. med Klaus Kenn, Head physician, Klinikum Berchtesgadener Land der Schön-Kliniken
ClinicalTrials.gov Identifier: NCT01384981     History of Changes
Other Study ID Numbers: BGL NIV
First Posted: June 29, 2011    Key Record Dates
Last Update Posted: September 4, 2015
Last Verified: September 2015

Keywords provided by Klaus Kenn, Klinikum Berchtesgadener Land der Schön-Kliniken:
chronic obstructive pulmonary rehabilitation
COPD
non invasive ventilation
NIV
exercise capacity
pulmonary rehabilitation

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases