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

ResMed

Status: Terminated

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Device: BiLevel Noninvasive Ventilation

Study type: Interventional

Funder types: Industry

Identifiers

NCT02100709

RMD_NIV_COPD_001

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Control Arm

No Intervention group

Description:

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

Intervention Arm

Active Comparator group

Description:

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

Treatment:

Device: BiLevel Noninvasive Ventilation