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

Not Applicable

Terminated

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Device: BiLevel Noninvasive Ventilation

• Registration Number: NCT02100709
• Lead Sponsor: ResMed

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-27
• Study First Submitted QC: 2014-03-31
• Study Start: 2014-04
• Study First Posted: 2014-04-01
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-28
• Last Update Posted: 2017-05-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Daily Physical Activity	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	6 Weeks	6 Minute Walking Distance will be measured every week during the exercise program.

Secondary Outcome Measures

Name	Time	Method
Quality of Life	3 Months	Using the St. George Respiratory Questionnaire before and after rehabilitation, quality of life will be measured.
Dyspnoea	6 Weeks	Change in Dyspnoea after end of exercise will be assessed using the Multidimensional Dyspnoea Profile and the BORG scale.
Change in Physiological Parameters	3 Months	Maximum training intensity, body weight and muscle diameter will be tracked throughout the training program.

Trial Locations

Locations (1)

Ruhrlandklinik; 🇩🇪 Tuschen, Essen, Germany