NIV-Training in Hypercapnic COPD Patients
Condition: COPD
MeSH terms: Hypercapnia
Study type: Interventional

Summary: 
      The aim of the study is to investigate the additional effects of the use of NIV during
      exercise within a 3-week PR program on exercise capacity in COPD patients with chronic
      hypercapnic respiratory failure.
    

Detailed description: 
      Scientific Background/ Rationale:

      Quality of life and exercise tolerance are commonly reduced in people with chronic
      obstructive pulmonary disease (COPD), especially in people with chronic hypercapnic
      respiratory failure (CHRF). Endurance exercise training as part of a pulmonary rehabilitation
      (PR) programme is an important treatment for people with COPD and has been shown to improve
      quality of life, exercise tolerance and physical activity. However, individuals with CHRF may
      have difficulties performing endurance exercise at an adequate training intensity to achieve
      the desired physiological changes.

      Non-invasive ventilation (NIV) is a method of providing breathing support using a ventilator
      and is usually delivered via a full face mask. A recent study showed that during a single
      exercise session in people with CHRF, NIV dramatically improves exercise tolerance and
      reduces breathlessness. Consequently, NIV used over a complete exercise training program may
      allow people with COPD and CHRF to exercise at a higher intensity to achieve greater
      improvement in exercise tolerance, quality of life and physical activity. So far this has
      only been tested in a small number of studies with small numbers of participants, and none
      with CHRF. It is currently not known from literature whether the demonstrated benefits of NIV
      during exercise training are clinically worthwhile or cost-effective.

      Aims The aim of the study is to investigate the additional effects of the use of NIV during
      exercise within a 3-week PR program on exercise capacity in COPD patients with chronic
      hypercapnic respiratory failure.

      Hypothesis It is assumed that a 3-week exercise training program with additional NIV, using
      titrated pressures, reduces the work of breathing. With this, it is theorized, COPD patients
      with CHRF are able to train for a longer duration and/ or with higher training intensities
      over the course of the training program and may achieve better PR outcomes.

      Primary Hypothesis:

      H.0: COPD-Patients with CHRF have the same increase in exercise capacity (endurance cycle
      time) when training with additional NIV as without NIV, during a 3-week PR program.

      H.1: COPD-Patients with CHRF have a superior increase in exercise capacity (endurance cycle
      time) when training with additional NIV as without NIV, during a 3-week PR program.

      Main Objective To determine if NIV during exercise is a useful tool for increasing exercise
      tolerance in hypercapnic patients, exercise tolerance (cycle endurance time) will be measured
      without NIV at PR admission/ discharge

      Materials and Method A total of 26 COPD patient (age: 40-80 years) in GOLD Stages IV
      diagnosed with CHRF, already treated with nocturnal NIV and referred for a comprehensive PR
      program will be recruited and randomized into two groups: 1) exercise with NIV during
      exercise (nocturnal NIV will continue) and 2) control group - exercise without NIV during
      exercise (nocturnal NIV will continue).

      Initially, patients will perform a maximum cardiopulmonary test to determine the Peak Work
      Rate (WRpeak). On a separate day, patients will perform a cycle endurance test (CET) at
      75%WRpeak without NIV using oxygen as prescribed, if needed. TcPCO2, heart rate and SpO2 via
      SenTec will be measured continuously during CET. In addition to the continuously recorded
      data, dyspnoea/ respiratory effort/ leg-fatigue (10-point Borg scale), capillary blood gases
      and the arterial blood pressure will be taken at the beginning/ end/ recovery/ isotime of the
      CET.
    

Intervention name(s): exercise training with non-invasive ventilation; standard exercise training without NIV
Intervention type(s): Other; Other
Intervention description(s): In the intervention group (exercise training with non-invasive ventilation) exercise NIV pressures will be optimally adjusted to each individual patient to decrease TcPCO2 values. An IPAP of at least 15 cmH20 will be used to provide sufficient pressure to relief patients breathing muscles. Nocturnal NIV will be continued.; In the control Group (standard exercise training without NIV ), patients will be execute cycle exercise without additional NIV (usual care). Nocturnal NIV will be continued.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A total of 26 COPD patients in GOLD Stages IV diagnosed with CHRF, already treated with nocturnal NIV and referred for a comprehensive PR program will be recruited and randomized into two groups: 1) exercise with NIV during exercise (nocturnal NIV will continue) and 2) control group - exercise without NIV during exercise (nocturnal NIV will continue).
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: CHRF; NIV; exercise training