healthy and COPD
Conditions
Interventions
N.A.
Sponsors
Radboudumc
Eligibility
Inclusion criteria
Inclusion criteria: In part 1, thirty healthy subject between 18-80 years are included, after signing informed consent. All subjects have a normal lung function (forced expiratory volume in 1 second (FEV1) > 80%).
Exclusion criteria
Exclusion criteria: In part 2, thirty COPD patients are included. All subjects have a lung function with FEV1 < 80%, corresponding to GOLD stage II-IV. Exclusion criteria, for both parts of the study, are physical impairment to perform physical tests, not fitting an available shirt, presence of a pacemaker or implantable cardioverter defibrillator, inability to read/understand Dutch language. And for COPD patients, an exacerbation within 1 month before inclusion is a exclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study parameter will answer the main objective, can the Hexoskin shirt accurately measure volume relative to the gold standard (spirometer or Oxycon Mobile). This analysis is performed in healthy subjects and later on in COPD patients. The Bland-Altman plot will be plotted as a percentage instead of a absolute difference. And is calculated with: ((volumes Method A – volumes Method B) / mean volumes of both methods x 100%), in which Method A is the Hexoskin shirt and Method B spirometer or Oxycon Mobile | — |
Secondary
| Measure | Time frame |
|---|---|
| repeatability of measurements in two sessions (ICC) effects of position and activity on the measurements with the Hexoskin (t-tests) bias calculated with the Bland-Altman plots Percentage error in volumes between Hexoskin shirt and gold standard experience of the subjects with the Hexoskin shirt | — |
Contacts
Public ContactD.C. Mannée
Nijmeegsebaan 31
Outcome results
None listed