Skip to content

Effect of non-invasive ventilation during exercise on dynamic hyperinflation in chronic obstructive pulmonary disease

The effect of non-invasive ventilation during exercise compared to unassisted breathing on dynamic hyperinflation in patients with chronic obstructive pulmonary disease

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12613000804785
Enrollment
21
Registered
2013-07-22
Start date
2016-05-09
Completion date
2019-05-06
Last updated
2020-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

AIM: The aim of this study is to determine the effect of NIV during exercise on DHI (Dynamic HyperInflation) in people with COPD (Chronic Obstructive Pulmonary Disease) compared to exercise without NIV (Noninvasive Ventilation). NIV with two different settings, standard and individualised, will be compared with no NIV. HYPOTHESIS: Non-invasive ventilation during exercise will reduce dynamic hyperinflation and increase exercise endurance time in people with COPD who dynamically hyperinflate during exercise compared to exercise without NIV. Individualised NIV will be more effective than standard NIV and no NIV in reducing DHI during exercise. POTENTIAL SIGNIFICANCE: Breathlessness is a major symptom for patients with severe COPD impacting adversely on physical performance and quality of life. The immediate effects of NIV during exercise include significant improvements in breathlessness and exercise endurance beyond those achieved with unassisted breathing in selected patients with severe COPD. These acute effects could significantly improve the efficacy of a pulmonary rehabilitation program by enabling people with COPD to exercise for longer or at a higher intensity.

Interventions

The trial will consist of three constant work rate Cardio Pulmonary Exercise Tests with and without Noninvasive Ventilation (BiLevel Positive Airway Pressure). The noninvasive ventilation will be administered once with a standard therapy and once with individually titrated expiratory pressure. The expiratory pressure will be determined by asking the patient to sit and receive different levels of pressure and perform an inspiratory capacity maneuver at each pressure. The pressure which provides

The trial will consist of three constant work rate Cardio Pulmonary Exercise Tests with and without Noninvasive Ventilation (BiLevel Positive Airway Pressure). The noninvasive ventilation will be administered once with a standard therapy and once with individually titrated expiratory pressure. The expiratory pressure will be determined by asking the patient to sit and receive different levels of pressure and perform an inspiratory capacity maneuver at each pressure. The pressure which provides the biggest inspiratory capacity will be the titrated expiratory pressure. This will be administered using a commercially available ventilator, the ResMed Stellar 150. The ventilator will be connected to the patient via a standard tube to a mask and a vent. The ventilator provides constant flow and a positive pressure to the mask. Both NIV arms will use the device in BiLevel pressure support mode. This mode has a square waveform with a high pressure during inspiration and a lower pressure during expiration. For both NIV arms, an inspiratory pressure of 15cmH2O will be used. The standard settings arm will use an expiratory pressure of 6cmH2O. The individual pressures will range from 2 - 10 cmH2O. The constant work rate exercise protocol will be done on a cycle ergometer. The work rate will be set after one minute of unloaded pedaling and the patient will be asked to pedal to exhaustion. The patients are expected to exercise from 4 - 20 minutes. The work rate will be chosen at 75% of the peak work rate found in an incremental maximal work rate test. The incremental test will be performed on the first day and the constant work rate tests will be in the subsequent days. The 3 constant work rate exercise tests will be separated by at least 1 hour but must be completed within 7 days of beginning to prevent bias due to change in baseline health.

Sponsors

University of Sydney
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No

Inclusion criteria

Diagnosis of severe to very severe COPD (FEV1/FVC < 70%, FEV1 < 50% predicted) Stable over the past month (i.e. no admissions to hospital, change in medications or increase in respiratory symptoms)

Exclusion criteria

Concomitant cardiovascular, orthopaedic or neurological conditions that are likely to impair exercise performance Other significant pulmonary disease (e.g. asthma) Major psychiatric illness Inability to give informed consent BMI > 32 kg/m2

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 22, 2026