The Effect of NIV on QoL and Exercise Capacity in a COPD Exercise Rehabilitation Program

Study Overview
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Brief Summary
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This trial hopes to demonstrate the effect of 4 weeks of outpatient exercise rehabilitation on COPD patients. In particular the effect on: the amount of daily physical activity Quality of life The 6-minute walk distance Time to exacerbation and compare it to the effect of 4 weeks of outpatients rehabilitation with Noninvasive Ventilation as an adjunct therapy.

Official Title
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The Effect of BiLevel Pressure Support NonInvasive Ventilation on Quality of Life and Exercise Capacity in a COPD Exercise Rehabilitation Program

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Device: BiLevel Noninvasive Ventilation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of COPD III+IV Age >18 years Former NIV treatment for at least 6 weeks with a positive end-expiratory pressure of at least 4 cmH2O and a pressure support of 8 cmH2O or higher Exclusion Criteria: Pulmonary Exacerbation requiring antibiotic treatment or hospitalization during the last 6 weeks non-pulmonary Exercise impairment (amputation, severe heart disease, etc) any disease that precludes exercise training inability to understand the patient information substance abuse oxygen requirement of more than 6l O2/min during exercise

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Arm<br>This arm will perform the pulmonary rehabilitation as specified with no respiratory assistance. | |
| Active Comparator: Intervention Arm<br>This arm will conduct the pulmonary rehabilitation program with BiLevel Noninvasive Ventilation assistance from a ResMed ventilator. | Device: BiLevel Noninvasive Ventilation<br>* Positive pressure applied through an oro-nasal mask. The pressure is altered between inspiration and expiration.<br>* Other names: PSV;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily Physical Activity | The primary outcome will be measured by daily activity using accelerometer arm bands. This will be measured at the beginning of the rehabilitation program, at the end and at a 3 month follow up. | 3 Months | 
| Exercise Capacity | 6 Minute Walking Distance will be measured every week during the exercise program. | 6 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | Using the St. George Respiratory Questionnaire before and after rehabilitation, quality of life will be measured. | 3 Months | 
| Dyspnoea | Change in Dyspnoea after end of exercise will be assessed using the Multidimensional Dyspnoea Profile and the BORG scale. | 6 Weeks | 
| Change in Physiological Parameters | Maximum training intensity, body weight and muscle diameter will be tracked throughout the training program. | 3 Months |