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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01384981
• Other study ID #: BGL NIV
• Status: Terminated
• Phase: N/A
• First received: June 27, 2011
• Last updated: September 3, 2015
• Start date: January 2011
• Est. completion date: September 2013

Study information

• Verified date: September 2015
• Source: Klinikum Berchtesgadener Land der Schön-Kliniken
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Procedure:
• pulmonary rehabilitation

Locations

Country	Name	City	State
Germany	Schön Klinik Berchtesgadener Land	Schönau am Königssee

Sponsors (2)

Lead Sponsor	Collaborator
Klinikum Berchtesgadener Land der Schön-Kliniken	ResMed

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in 6 minute walking distance	change in 6 minute walking distance from baseline to day 25	day 1 and 25	No
Secondary	change in quality of life (chronic respiratory questionnaire, CRQ)	change in CRQ-Score from baseline to day 25	day 1 and 25	No
Secondary	change quality of life (Saint George´s Respiratory Questionnaire, SGRQ)	change in SGRQ-Score from baseline to day 25	day 1 and 25	No