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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
pulmonary rehabilitation
Sponsored by
Schön Klinik Berchtesgadener Land
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring chronic obstructive pulmonary rehabilitation, COPD, non invasive ventilation, NIV, exercise capacity, pulmonary rehabilitation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Schön Klinik Berchtesgadener Land

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

pulmonary rehabilitation with NIV

pulmonary rehabilitation without NIV

Arm Description

Patients receiving nocturnal non-invasiv Ventilation during a 3-week pulmonary Rehabilitation program.

Patients receiving no nocturnal non-invasiv Ventilation during a 3-week pulmonary Rehabilitation program.

Outcomes

Primary Outcome Measures

change in 6 minute walking distance
change in 6 minute walking distance from baseline to day 25

Secondary Outcome Measures

change in quality of life (chronic respiratory questionnaire, CRQ)
change in CRQ-Score from baseline to day 25
change quality of life (Saint George´s Respiratory Questionnaire, SGRQ)
change in SGRQ-Score from baseline to day 25

Full Information

First Posted
June 27, 2011
Last Updated
September 3, 2015
Sponsor
Schön Klinik Berchtesgadener Land
Collaborators
ResMed
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1. Study Identification

Unique Protocol Identification Number
NCT01384981
Brief Title
Effects of Non-invasive Ventilation on Rehabilitation Outcome in COPD-patients
Official Title
Effects of Non-invasive Ventilation on Exercise Capacity and Quality of Life in COPD-patients GOLD III/IV
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Terminated
Why Stopped
major problems in recruiting patients due to very strict inclusion criteria
Study Start Date
January 2011 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Schön Klinik Berchtesgadener Land
Collaborators
ResMed

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
chronic obstructive pulmonary rehabilitation, COPD, non invasive ventilation, NIV, exercise capacity, pulmonary rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pulmonary rehabilitation with NIV
Arm Type
Active Comparator
Arm Description
Patients receiving nocturnal non-invasiv Ventilation during a 3-week pulmonary Rehabilitation program.
Arm Title
pulmonary rehabilitation without NIV
Arm Type
Sham Comparator
Arm Description
Patients receiving no nocturnal non-invasiv Ventilation during a 3-week pulmonary Rehabilitation program.
Intervention Type
Procedure
Intervention Name(s)
pulmonary rehabilitation
Primary Outcome Measure Information:
Title
change in 6 minute walking distance
Description
change in 6 minute walking distance from baseline to day 25
Time Frame
day 1 and 25
Secondary Outcome Measure Information:
Title
change in quality of life (chronic respiratory questionnaire, CRQ)
Description
change in CRQ-Score from baseline to day 25
Time Frame
day 1 and 25
Title
change quality of life (Saint George´s Respiratory Questionnaire, SGRQ)
Description
change in SGRQ-Score from baseline to day 25
Time Frame
day 1 and 25

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Schön Klinik Berchtesgadener Land
City
Schönau am Königssee
ZIP/Postal Code
83471
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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