Influence of the VitaBreath on Exercise Tolerance in COPD
Chronic Obstructive Pulmonary Disease
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Chronic Obstructive Pulmonary Disease, Non-invasive ventilation
Eligibility Criteria
Inclusion Criteria:
- Male or female aged 40 years or older.
- Current or previous smoking history: 10 or more pack years.
- Spirometry confirmed stable COPD (GOLD stages II-IV) under optimal medical therapy.
- Exhibit substantial exercise-induced dynamic hyperinflation (ΔIC baseline > 0.15 L)
Exclusion Criteria:
- Orthopaedic, neurological or other concomitant diseases that significantly impair normal biomechanical movement patterns, as judged by the investigator.
- Moderate or severe COPD exacerbation within 6 weeks.
- Unstable cardiac arrhythmia.
- Unstable ischaemic heart disease, including myocardial infarction within 6 weeks.
- Moderate or severe aortic stenosis or hypertrophic obstructive cardiomyopathy.
- Uncontrolled hypertension.
- Uncontrolled hypotension (SBP<85mmHg).
- Uncontrolled diabetes.
- Intolerance of the VitaBreath device.
Sites / Locations
- North Tyneside General Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Continuous exercise
Interval exercise
Patients will undergo a constant load exercise protocol with gas exchange analysis on a cycle ergometer. The exercise protocol will be consisted of repeated 6-min exercise bouts, separated by 2-min rest periods in between work bouts in order to allow application of the VitaBreath device. During the 1st min of each resting period participants will breathe either via the VitaBreath device or normally adopting the pursed lip breathing technique. During the 2nd min of each resting period participants will breathe normally and perform an IC maneuver to assess the magnitude of dynamic hyperinflation.
Patients will undergo an interval exercise protocol with gas exchange analysis on a cycle ergometer. The exercise protocol will consist of repeated 2-min exercise bouts, separated by 2-min resting periods in between work bouts in order to allow application of the VitaBreath device. During the 1st min of each resting period participants will breathe either via the VitaBreath device or normally adopting the pursed lip breathing technique. During the 2nd min of each rest period participants will breathe normally and perform an IC maneuver, to assess the magnitude of dynamic hyperinflation.