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Clinical Trials/NCT02100709
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

ResMed1 site in 1 country14 target enrollmentApril 2014

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.

Registry
clinicaltrials.gov
Start Date
April 2014
End Date
October 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
ResMed
Responsible Party
Sponsor

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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