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

NCT01384981 | Terminated

• 1 other identifier: BGL NIV
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

chronic obstructive pulmonary rehabilitation; COPD; non invasive ventilation; NIV; exercise capacity; pulmonary rehabilitation

Outcome Measures

Primary Outcomes (1)

• change in 6 minute walking distance

  change in 6 minute walking distance from baseline to day 25

  day 1 and 25

Secondary Outcomes (2)

• change in quality of life (chronic respiratory questionnaire, CRQ)

  day 1 and 25

• change quality of life (Saint George´s Respiratory Questionnaire, SGRQ)

  day 1 and 25

Study Arms (2)

pulmonary rehabilitation with NIV

ACTIVE COMPARATOR

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

Procedure: pulmonary rehabilitation

pulmonary rehabilitation without NIV

SHAM COMPARATOR

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

Procedure: pulmonary rehabilitation

Interventions

pulmonary rehabilitation PROCEDURE

pulmonary rehabilitation with NIV; pulmonary rehabilitation without NIV

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Schön Klinik Berchtesgadener Land: lead
• ResMed: collaborator

Study Sites (1)

Schön Klinik Berchtesgadener Land

Schönau am Königssee, 83471, Germany

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med Klaus Kenn, Head physician

Study Record Dates

• First Submitted: June 27, 2011
• First Posted: June 29, 2011
• Study Start: January 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: September 4, 2015

Record last verified: 2015-09

Locations

DE (1)