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

ResMed14 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

BiLevel Noninvasive VentilationDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

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

Locations (1)

Ruhrlandklinik

Tuschen, Hesse, Germany

Outcomes

Primary Outcomes

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.

Time frame: 3 Months

Exercise Capacity

6 Minute Walking Distance will be measured every week during the exercise program.

Time frame: 6 Weeks

Secondary Outcomes

Quality of Life

Using the St. George Respiratory Questionnaire before and after rehabilitation, quality of life will be measured.

Time frame: 3 Months

Dyspnoea

Change in Dyspnoea after end of exercise will be assessed using the Multidimensional Dyspnoea Profile and the BORG scale.

Time frame: 6 Weeks

Change in Physiological Parameters

Maximum training intensity, body weight and muscle diameter will be tracked throughout the training program.

Time frame: 3 Months

Data from ClinicalTrials.gov

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