NCT02100709
Terminated
Not Applicable
The Effect of BiLevel Pressure Support NonInvasive Ventilation on Quality of Life and Exercise Capacity in a COPD Exercise Rehabilitation Program
ConditionsChronic Obstructive Pulmonary Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Obstructive Pulmonary Disease
- Sponsor
- ResMed
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Daily Physical Activity
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Daily Physical Activity
Time Frame: 3 Months
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.
Exercise Capacity
Time Frame: 6 Weeks
6 Minute Walking Distance will be measured every week during the exercise program.
Secondary Outcomes
- Quality of Life(3 Months)
- Dyspnoea(6 Weeks)
- Change in Physiological Parameters(3 Months)
Study Sites (1)
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