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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of the Role of Nocturnal Non-Invasive Ventilation in Pulmonary Rehabilitation

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Device: non invasive ventilation (Resmed VPAP III ST-A, Respironics Harmony)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control group<br>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<br>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)<br>* non invasive ventilation was performed with commercially available ventilators from the manufacturers Resmed and Respironics.<br>* Other names: Respironics Harmony;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| six minute walk distance |  | beginning to end of rehabilitation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life |  | beginning to end of rehabilitation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, non invasive ventilation, pulmonary rehabilitation