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

NCT02100709 | Terminated

• 1 other identifier: RMD_NIV_COPD_001
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (2)

• 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.

  3 Months

• Exercise Capacity

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

  6 Weeks

Secondary Outcomes (3)

• Quality of Life

  3 Months

• Dyspnoea

  6 Weeks

• Change in Physiological Parameters

  3 Months

Other Outcomes (1)

• Time to pulmonary exacerbation

  12 Months

Study Arms (2)

Control Arm

NO INTERVENTION

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

Intervention Arm

ACTIVE COMPARATOR

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

Device: BiLevel Noninvasive Ventilation

Interventions

BiLevel Noninvasive Ventilation DEVICE

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

Also known as: NIV, BiPAP, Pressure Support Ventilation, PSV

Intervention Arm

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ResMed: lead

Study Sites (1)

Ruhrlandklinik

Tuschen, Hesse, 45239, Germany

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Helmut Teschler, Prof. Dr. med.

  Dept. Respiratory & Sleep Medicine - Ruhrlandklinik

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2014
• First Posted: April 1, 2014
• Study Start: April 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: May 2, 2017

Record last verified: 2017-04

Locations

DE (1)