COPD dyspnea
Conditions
Interventions
Please see study design above.
Sponsors
Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1.Subject must have a clinical diagnosis of COPD 2. mMRC (Modified Medical Research Council) Dyspnea Scale Score > 1 3. Subject must be indicated for regular inpatient/outpatient pulmonary rehabilitation at CIRO 4. Subject must be willing to provide Informed Consent for their participation in the study 5. Subject must be >=18 years of age
Exclusion criteria
Exclusion criteria: 1. Subjects who are unable/unwilling to voluntarily participate in the study 2.Subjects who cannot read/write 3. Subject has congenital heart disease 4.Subject has unstable coronary artery disease 5.Subject has an active implanted cardiac device (i.e. IPG, ICD) 6.Subject has heart failure NYHA 4 7.Subject presents any concomitant condition which in the opinion of the investigator would not allow a safe participation in the study 8.Subject is legally incompetent 9.Subject is pregnant or has suspect to be pregnant 10.Subject is enrolled in a concurrent study that may confound the results of this study without documented pre-approval from Medtronic study manager 11. BORG scale assessment is evaluated as unreliable due to patient*s cognitive condition
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective and endpoint of the study is: • To evaluate the EMG of respiratory muscles during various levels of dyspnea and exertion in COPD patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives of this study are: • To characterize EMG, respiration rate, SpO2 and patient-reported health information (about dyspnea and other symptoms) before, during and after acute exacerbations of COPD; • To characterize the respiration rate during various levels of dyspnea and exertion in COPD patients; •To characterize the SpO2during various levels of dyspnea and exertion in COPD patients. Secondary endpoints are: • Change in EMG, respiration rate, SpO2 and patient-reported health information (Exact-PRO) before, during and after exacerbations of COPD. • Correlation between respiration rate, as measured by the BioNomadix wearable data logger system, and Borg scale during exercise • Correlation between SpO2 as measured by the WristOx2 3150 wearable pulse oximeter, and Borg scale during exercise | — |
Countries
Netherlands
Outcome results
None listed