COPD: Chronic Obstructive Pulmonary Disease
Conditions
Interventions
COPD
Dyspnea
Morningsymptoms
MoveMonitor
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: COPD stage II-IV diagnosed according to GOLD Aged between >= 40 years and
Exclusion criteria
Exclusion criteria: Diagnosis of asthma Exacerbation of COPD within the past 2 months. See protocol page 9 for details. History of sensitization to allergens Significant other lung disease Comorbidities and severe pain syndromes, which impair exercise capacity Interfering malignant diseases Clinical signs of acute heart failure Serious mental impairment. See protocol page 9 for details Current participation in a clinical rehabilitation programme
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is: The occurrence and burden of morning symptoms. This will be assessed by applying the Morning Symptoms questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Spirometry measures (VC, FVC, IC, FEV1) • Lung volumes (FRC, RV and TLC) • Physical function test (6 minute walking test) • MRC Dyspnea scale • St. George Respiratory Questionnaire (SGRQ) • Clinical COPD questionnaire (CCQ) • International physical activity questionnaire (IPAQ) • COPD assesment test (CAT) • COPD and Asthma Sleep Impact Scale (CASIS) • Hospital Anxiety and Depression Scale (HADS) • PROactive Physical Activity in COPD (C-PPAC) • Absolute number of eosinophils • Expression of different pro- and anti-inflammatory genes • Monitoring of the following parameters by using the MoveMonitor (mcRoberts): o intensity of walking o mean duration of sitting periods o mean duration of standing o nocturnal unrest and o pattern analysis of sleeping quality. | — |
Countries
The Netherlands
Outcome results
None listed