Evaluation of the Role of Nocturnal Non-Invasive Ventilation in Pulmonary Rehabilitation
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|ClinicalTrials.gov Identifier: NCT00710463|
Recruitment Status : Completed
First Posted : July 4, 2008
Last Update Posted : July 4, 2008
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 or disease||Intervention/treatment|
|Pulmonary Disease, Chronic Obstructive||Device: non invasive ventilation (Resmed VPAP III ST-A, Respironics Harmony)|
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.
|Study Type :||Observational|
|Actual Enrollment :||80 participants|
|Official Title:||Evaluation of the Role of Nocturnal Non-Invasive Ventilation in Pulmonary Rehabilitation|
|Study Start Date :||May 2003|
|Actual Primary Completion Date :||September 2007|
|Actual Study Completion Date :||November 2007|
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.
- six minute walk distance [ Time Frame: beginning to end of rehabilitation ]
- quality of life [ Time Frame: beginning to end of rehabilitation ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00710463
|Klinikum Berchtesgadener Land|
|Berchtesgaden, Germany, D-83471|
|Study Director:||Klaus Kenn, MD||Klinikum Berchtesgadener Land|
|Principal Investigator:||Ursula Schönheit-Kenn, ME||Klinikum Berchtesgadener Land|