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

NCT ID: NCT01384981

Last Updated: 2015-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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pulmonary rehabilitation with NIV

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

Group Type ACTIVE_COMPARATOR

pulmonary rehabilitation

Intervention Type PROCEDURE

pulmonary rehabilitation without NIV

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

Group Type SHAM_COMPARATOR

pulmonary rehabilitation

Intervention Type PROCEDURE

Interventions

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pulmonary rehabilitation

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ResMed

INDUSTRY

Sponsor Role collaborator

Schön Klinik Berchtesgadener Land

OTHER

Sponsor Role lead

Responsible Party

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Klaus Kenn

Dr. med Klaus Kenn, Head physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Schön Klinik Berchtesgadener Land

Schönau am Königssee, , Germany

Site Status

Countries

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Germany

Other Identifiers

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BGL NIV

Identifier Type: -

Identifier Source: org_study_id

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