Chronic Obstructive Pulmonary Disease (COPD) Respiratory Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Interventions
Participants in this study attend three visits to the study centre over a ten day period. The total duration of each visit is expected to last for approximately one hour. Patients perform the three te
Sponsors
Philips
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female aged 40 years or older 2. Current or previous smoking history, 10 or more pack years 3. Spirometry confirmed stable COPD (GOLD stages II-IV) under optimal medical therapy 4. Exhibit substantial exercise-induced dynamic hyperinflation (?IC baseline > 0,2 L)
Exclusion criteria
Exclusion criteria: 1. Orthopaedic, neurological or other concomitant diseases that significantly impair normal biomechanical movement patterns, as judged by the investigator 2. Moderate or severe COPD exacerbation within 6 weeks 3. Unstable cardiac arrhythmia 4. Unstable ischaemic heart disease, including myocardial infarction within 6 weeks 5. Moderate or severe aortic stenosis or hypertrophic obstructive cardiomyopathy 6. Uncontrolled hypertension 7. Uncontrolled hypotension (SBP<85mmHg) 8. Uncontrolled diabetes 9. Intolerance of the VitaBreath device
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Exercise tolerance (total exercise time in minutes) is measured using two different exercise modalities (i.e. continuous or interval) and two different interventions for each modality (i.e.: the VitaBreath device or normal breathing asking the patients to perform the pursed lip breathing technique) at baseline visit, visit 2 and visit 3 (over a ten day period) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Breathlessness is assessed using the Borg 1-10 scale during exercise of different exercise modalities at baseline visit, visit 2 and visit 3 (over a ten day period) 2. Dynamic hyperinflation (DH) is assessed by the inspiratory capacity maneuvers (IC) at baseline visit, visit 2 and visit 3 (over a ten day period) 3. Oxygen uptake (VO2) is measured using a portable gas analyzer (K4b2Cardiac output) at baseline visit, visit 2 and visit 3 (over a ten day period) 4. Cardiac Output (CO) is measured using the noninvasive bioelectrical conductance method, namely PhysioFlow during exercise of different exercise modalities at baseline visit, visit 2 and visit 3 (over a ten day period) 5. Heart rate (HR) is measured using the noninvasive bioelectrical conductance method, namely PhysioFlow during exercise of different exercise modalities at baseline visit, visit 2 and visit 3 (over a ten day period) 7. Stroke volume (SV) is measured using the noninvasive bioelectrical conductance method, namely PhysioFlow during exercise of different exercise modalities at baseline visit, visit 2 and visit 3 (over a ten day period) 7. Arteriovenous oxygen difference content (a-vO2) is calculated using the Fick equation during exercise of different exercise modalities at baseline visit, visit 2 and visit 3 (over a ten day period) 8. Arterial oxygen saturation (SpO2) is measured using an oximeter during exercise of different exercise modalities at baseline visit, visit 2 and visit 3 (over a ten day period) 9. Minute ventilation (VE) is measured using a portable gas analyzer (K4b2) during exercise of different exercise modalities at baseline visit, visit 2 and visit 3 (over a ten day period) 10. Inspiratory time (Ti) is measured using a portable gas analyzer (K4b2) during exercise of different exercise modalities at baseline visit, visit 2 and visit 3 ( | — |
Countries
United Kingdom
Contacts
Public ContactStephen Bourke
Outcome results
None listed