Influence of the VitaBreath on Exercise Tolerance in COPD
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      People with COPD have more air in their lungs than other people (this problem with high lung
      volumes is called "hyperinflation"). Unfortunately this is unhelpful as breathing at higher
      lung volumes requires more effort and contributes to breathlessness. When anyone exercises,
      they breathe more quickly. People with COPD have narrowed airways, which makes breathing out
      difficult. When they breathe more quickly they may not be able to breathe out fully before
      they need to take the next breath in. This means that the volume of air in their lungs tends
      to increase further during exercise, which makes breathing even more difficult. This problem
      is called "dynamic hyperinflation".

      Pulmonary rehabilitation is one of the most helpful interventions for people with COPD and
      most of the benefit gained is from exercise. Anything that helps people increase the amount
      of exercise they can perform should lead to further improvements.

      Non-invasive positive pressure ventilation is a method of supporting a person's normal
      breathing. The ventilator delivers a flow of air at low pressure as you breathe out, which
      helps patients to breathe out more completely. The device also detects when patients start to
      breathe in and delivers a stronger flow of air at a higher pressure, helping them to take a
      deeper breath in. Previous research studies have shown that when people with COPD use
      non-invasive ventilation during exercise they are able to exercise for longer and are less
      breathless. The purpose of this study is to assess whether a new portable non-invasive
      ventilation device, called the VitaBreath, helps people with COPD recover from breathlessness
      during the exercise breaks more quickly (by reducing "dynamic hyperinflation", described
      above) and to exercise for longer overall. The VitaBreath device is small and light, weighing
      0.5 kilograms (just over one pound). It is handheld and battery powered.
    

Detailed description: 
      In patients with chronic obstructive pulmonary disease (COPD) dynamic hyperinflation (DH) and
      the concurrent mechanical constraints on tidal volume expansion during exercise increase work
      of breathing and perceived respiratory discomfort, limiting endurance. An additional
      consequence of DH and the concomitant high mean intrathoracic pressure swings, cardiac
      performance and, hence, supply of oxygenated blood to the malfunctioning peripheral muscles
      is further compromised. This contributes to perceived leg discomfort and exercise
      intolerance.

      Bronchodilator therapy is associated with a reduction in operating lung volumes, leading to
      improvements in perceived breathlessness and exercise tolerance. Heliox (helium and oxygen)
      is less dense and generates less airway resistance than air. Heliox breathing has been shown
      to improve exercise tolerance in COPD. A recent study demonstrated that compared to room air,
      breathing heliox during constant-load exercise (CLE) (continuous) increased inspiratory
      capacity (IC), and lessened DH, breathlessness and leg discomfort at isotime and at the point
      of exercise limitation. In addition, heliox breathing increased stroke volume, cardiac output
      and hence locomotor muscle oxygen delivery. However, the main drawback of heliox
      supplementation is the high cost, especially when it is used for long periods of time.
      Previous studies using inspiratory pressure support have shown improvements in dyspnoea and
      exercise capacity by reducing the work of breathing, as well as improved central hemodynamic
      responses and peripheral muscle oxygenation.

      In comparison to traditional noninvasive ventilators, the Vitabreath device, which provides
      positive inspiratory pressure, is compact, light and inexpensive. Ease of operation,
      portability and battery life support use to aid relief of breathlessness, including away from
      the patient's home. This should facilitate maintenance of, and improvement in, activity.
      Vitabreath may also prove to be a useful tool to increasing exercise tolerance and the
      intensity of training, and hence the magnitude of physiological adaptations by mitigating DH
      during rehabilitative exercise training.
    

Intervention name(s): VitaBreath; Pursed Lip Breathing technique
Intervention type(s): Device; Other
Intervention description(s): The VitaBreath devise will be applied during the 1st minute of each resting period between exercise bouts and during the 1st minute of recovery.; Pursed Lip Breathing technique will be applied during the 1st minute of each resting period between exercise bouts and during the 1st minute of recovery.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a randomized crossover trial. The two exercise modalities will be separately assessed in different groups of patients, but within each group the intervention (VitaBreath) will be compared to control (pursed-lip breathing).
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Obstructive Pulmonary Disease; Non-invasive ventilation