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

This study is currently recruiting participants.
Verified December 2011 by Klinikum Berchtesgadener Land der Schön-Kliniken
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: December 9, 2011
Last verified: December 2011
History of Changes
  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 with NIV
Procedure: Pulmonary rehabilitation without NIV

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:

U.S. FDA Resources

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


Estimated Enrollment: 80
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
nocturnal non invasive ventilation in addition to pulmonary rehabilitation
 Procedure: pulmonary rehabilitation with NIV
nocturnal non invasive ventilation in addition to pulmonary rehabilitation
No Intervention: pulmonary rehabilitation without NIV
pulmonary rehabilitation (3 week) without NIV
 Procedure: Pulmonary rehabilitation without NIV
pulmonary rehabilitation without NIV

  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

Contacts
Contact: Klaus Kenn, Dr. med. 0049865293 ext 1540 iheinzelmann@schoen-kliniken.de

Locations
Germany
Schön Klinik Berchtesgadener Land Recruiting
Schönau am Königssee, Germany, 83471
Contact: Klaus Kenn, Dr. med.     0049865293 ext 1540     iheinzelmann@schoen-kliniken.de    
Sub-Investigator: Inga Heinzelmann            
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: December 9, 2011
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 May 22, 2013