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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2016-10-31

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.

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Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control Arm

This arm will perform the pulmonary rehabilitation as specified with no respiratory assistance.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention Arm

This arm will conduct the pulmonary rehabilitation program with BiLevel Noninvasive Ventilation assistance from a ResMed ventilator.

Group Type ACTIVE_COMPARATOR

BiLevel Noninvasive Ventilation

Intervention Type DEVICE

Positive pressure applied through an oro-nasal mask. The pressure is altered between inspiration and expiration.

Interventions

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BiLevel Noninvasive Ventilation

Positive pressure applied through an oro-nasal mask. The pressure is altered between inspiration and expiration.

Intervention Type DEVICE

Other Intervention Names

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NIV BiPAP Pressure Support Ventilation PSV

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No