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

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.

Full Title of Study: “The Effect of BiLevel Pressure Support NonInvasive Ventilation on Quality of Life and Exercise Capacity in a COPD Exercise Rehabilitation Program”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2016

Interventions

  • Device: BiLevel Noninvasive Ventilation
    • Positive pressure applied through an oro-nasal mask. The pressure is altered between inspiration and expiration.

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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.
  • Exercise Capacity
    • Time Frame: 6 Weeks
    • 6 Minute Walking Distance will be measured every week during the exercise program.

Secondary Measures

  • Quality of Life
    • Time Frame: 3 Months
    • Using the St. George Respiratory Questionnaire before and after rehabilitation, quality of life will be measured.
  • Dyspnoea
    • Time Frame: 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
    • Time Frame: 3 Months
    • Maximum training intensity, body weight and muscle diameter will be tracked throughout the training program.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 120 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • ResMed
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Helmut Teschler, Prof. Dr. med., Principal Investigator, Dept. Respiratory & Sleep Medicine – Ruhrlandklinik

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