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

This study has been terminated.
(major problems in recruiting patients due to very strict inclusion criteria)
Sponsor:
Collaborator:
ResMed
Information provided by (Responsible Party):
Klaus Kenn, Klinikum Berchtesgadener Land der Schön-Kliniken
ClinicalTrials.gov Identifier:
NCT01384981
First received: June 27, 2011
Last updated: September 30, 2013
Last verified: September 2013
  Purpose

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 Intervention
Chronic Obstructive Pulmonary Disease
Procedure: pulmonary rehabilitation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Klinikum Berchtesgadener Land der Schön-Kliniken:

Primary Outcome Measures:
  • change in 6 minute walking distance [ Time Frame: day 1 and 25 ] [ Designated as safety issue: No ]
    change in 6 minute walking distance from baseline to day 25


Secondary Outcome Measures:
  • change in quality of life (chronic respiratory questionnaire, CRQ) [ Time Frame: day 1 and 25 ] [ Designated as safety issue: No ]
    change in CRQ-Score from baseline to day 25

  • change quality of life (Saint George´s Respiratory Questionnaire, SGRQ) [ Time Frame: day 1 and 25 ] [ Designated as safety issue: No ]
    change in SGRQ-Score from baseline to day 25


Enrollment: 31
Study Start Date: January 2011
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: pulmonary rehabilitation with NIV Procedure: pulmonary rehabilitation
Sham Comparator: pulmonary rehabilitation without NIV Procedure: pulmonary rehabilitation

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01384981

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

No publications provided

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
Study First Received: June 27, 2011
Last Updated: September 30, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by 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
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014