Evaluation of the Role of Nocturnal Non-Invasive Ventilation in Pulmonary Rehabilitation - Full Text View

Sponsors and Collaborators:	Deutsche Lungenstiftung e.V. Hannover Medical School
Information provided by:	Deutsche Lungenstiftung e.V.
ClinicalTrials.gov Identifier:	NCT00710463

Purpose

Hypothesis: Hospital based, comprehensive pulmonary rehabilitation of patients with COPD in GOLD stage IV can be optimized by application of nocturnal non invasive ventilation. This hypotheses shall be tested by an observational trial, comparing rehabilitation effects of a prospectively observed group receiving non invasive ventilation, compared wiht a historical control group of patients who did received the same treatment without non invasive ventilation.

Condition	Intervention
Pulmonary Disease, Chronic Obstructive	Device: non invasive ventilation (Resmed VPAP III ST-A, Respironics Harmony)

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease) Rehabilitation

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort
Official Title:	Evaluation of the Role of Nocturnal Non-Invasive Ventilation in Pulmonary Rehabilitation

Further study details as provided by Deutsche Lungenstiftung e.V.:

Primary Outcome Measures:

six minute walk distance [ Time Frame: beginning to end of rehabilitation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

quality of life [ Time Frame: beginning to end of rehabilitation ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	80
Study Start Date:	May 2003
Study Completion Date:	November 2007
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Control group patients receive a hospital based comprehensive pulmonary rehabilitation programme, including endurance training, physiotherapy, medical therapy, and long term oxygen treatment when indicated.
NIV treatment group patients receive a hospital based comprehensive pulmonary rehabilitation programme, including endurance training, physiotherapy, medical therapy, and long term oxygen treatment when indicated, plus newly introduced nocturnal non invasive ventilation.	Device: non invasive ventilation (Resmed VPAP III ST-A, Respironics Harmony) non invasive ventilation was performed with commercially available ventilators from the manufacturers Resmed and Respironics.

Detailed Description:

Non invasive ventilation is known to allow improvements if applied during endurance training, but this is technically difficult. Nocturnal application of non invasive ventilation is known to unload the ventilatory pump, reset the control of breathing, and improve sleep quality.

The protocol also aimed to evaluate the acceptance of non invasive ventilation in patients undergoing a four week inpatient pulmonary rehabilitation programme.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

All patients were recruited at a single center, the rehabilitation hospital "Klinikum Berchtesgadener Land" at Germany.

Patients entering the well defined, hospital based pulmonary rehabilitation programme after Januar 1, 2005 were additionally treated with nocturnal non invasive ventilation. The results of these patients were compared with a group of patients who underwent the same rehabilitation programme in the years 2003 to 2005, when non invasive ventilation was not availabe.

Criteria

Inclusion Criteria:

Confirmed diagnosis of COPD in stages GOLD IV
Receiving optimized medical treatment and long term oxygen treatment, if indicated
Patient's consent to participate in this trial

Exclusion Criteria:

Previous treatment with NIPPV
Unwillingness or intolerance to perform NIPPV
Acute exacerbation of COPD at baseline or during pulmonary rehabilitation,
Significant orthopaedic or neurologic problems that reduce mobility or cooperation with physical training
Poor controlled coexisting psychiatric or unstable cardiac disease,
Inability to perform a six minute walk test
Extreme hypercapnia (pCO2 > 74 mmHg)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00710463

Locations

Germany
Klinikum Berchtesgadener Land
Berchtesgaden, Germany, D-83471

Sponsors and Collaborators

Deutsche Lungenstiftung e.V.

Hannover Medical School

Investigators

Study Director:	Klaus Kenn, MD	Klinikum Berchtesgadener Land
Principal Investigator:	Ursula Schönheit-Kenn, ME	Klinikum Berchtesgadener Land

More Information

No publications provided

Responsible Party:	Klinikum Berchtesgadener Land, Malterhöh 1, D-83471 Berchtesgaden ( Dr. Klaus Kenn )
Study ID Numbers:	NIV and Rehabilitation
Study First Received:	July 2, 2008
Last Updated:	July 3, 2008
ClinicalTrials.gov Identifier:	NCT00710463 History of Changes
Health Authority:	Germany: Ethics Commission

Keywords provided by Deutsche Lungenstiftung e.V.:

COPD
non invasive ventilation
pulmonary rehabilitation

Study placed in the following topic categories:

Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases

Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on May 07, 2009