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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 02, 2014