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| Name | Class |
|---|---|
| Hannover Medical School | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| non invasive ventilation (Resmed VPAP III ST-A, Respironics Harmony) | Device | non invasive ventilation was performed with commercially available ventilators from the manufacturers Resmed and Respironics. |
| Measure | Description | Time Frame |
|---|---|---|
| six minute walk distance | beginning to end of rehabilitation |
| Measure | Description | Time Frame |
|---|---|---|
| quality of life | beginning to end of rehabilitation |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Klaus Kenn, MD | Klinikum Berchtesgadener Land | Study Director |
| Ursula Schönheit-Kenn, ME | Klinikum Berchtesgadener Land | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Berchtesgadener Land | Berchtesgaden | D-83471 | Germany |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D063087 | Noninvasive Ventilation |
| ID | Term |
|---|---|
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |