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

April 28, 2017 updated by: ResMed

The Effect of BiLevel Pressure Support NonInvasive Ventilation on Quality of Life and Exercise Capacity in a COPD Exercise Rehabilitation Program

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Essen
      • Tuschen, Essen, Germany, 45239
        • Ruhrlandklinik

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Arm
This arm will perform the pulmonary rehabilitation as specified with no respiratory assistance.
Active Comparator: Intervention Arm
This arm will conduct the pulmonary rehabilitation program with BiLevel Noninvasive Ventilation assistance from a ResMed ventilator.
Device: BiLevel Noninvasive Ventilation
Positive pressure applied through an oro-nasal mask. The pressure is altered between inspiration and expiration.
Other Names:
  • BiPAP
  • NIV
  • Pressure Support Ventilation
  • PSV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Daily Physical Activity
Time Frame: 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.
3 Months
Exercise Capacity
Time Frame: 6 Weeks
6 Minute Walking Distance will be measured every week during the exercise program.
6 Weeks

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to pulmonary exacerbation
Time Frame: 12 Months
The average time to exacerbation between groups will be analysed post trial.
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ResMed

Investigators

  • Principal Investigator: Helmut Teschler, Prof. Dr. med., Dept. Respiratory & Sleep Medicine - Ruhrlandklinik

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

March 27, 2014

First Submitted That Met QC Criteria

March 31, 2014

First Posted (Estimate)

April 1, 2014

Study Record Updates

Last Update Posted (Actual)

May 2, 2017

Last Update Submitted That Met QC Criteria

April 28, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RMD_NIV_COPD_001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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