Pulmonary Disease, Chronic Obstructive
Conditions
Brief summary
This is a study to provide an in-depth validation of the 1-minute sit-to-stand test as a measure of exercise capacity in patients with chronic obstructive pulmonary disease (COPD). Patients will perform the 1-minute sit-to-stand test and other validated exercise tests and questionnaires.
Detailed description
Exercise capacity is a strong predictor for mortality, exacerbations and health-related quality of life (HRQL) in patients with chronic obstructive pulmonary disease (COPD). The 1-minute sit-to-stand test (1-min STS test) is a promising exercise capacity test that is simple to conduct and requires few resources. This study will provide an in-depth validation of the 1-min STS test, specifically evaluating the tests reliability, validity, responsiveness to change and minimal clinically important difference. The study will also assess the predictive properties of the 1-min STS test with regards to detecting exacerbations, as well as identify patterns of physical activity and patient-reported symptoms of exacerbations.
Interventions
Validation of the 1-minute sit-to-stand test in a COPD patient population
Sponsors
University of Zurich
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* COPD diagnosis according to GOLD criteria; post bronchodilator FEV1/FVC\<70% * Male and female patients ≥40 years of age * Able to do at least 5 repetitions in the 1-min STS test at baseline assessment * Written informed consent by the participant
Exclusion criteria
* Lower limb joint surgery in the preceding 3 months * Too unstable medically to perform exercise tests * Predominant neurological or musculoskeletal limitation to walking * Cognitive reading impairment and/or difficulties managing the eDiary and step-counter
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1-minute sit-to-stand test | Change from baseline after pulmonary rehabilitation programme | Number of repetitions performed in the 1-minute sit-to-stand test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart Rate | Change from baseline (pre-exercise test) during and after test | — |
| 6-minute walk test | Change from baseline after pulmonary rehabilitation programme | Distance walked in 6 minutes |
| Respiratory exchange ratio (RER) | Change from baseline (pre-exercise test) during and after test | — |
| 5-repetition sit-to-stand test | Change from baseline after pulmonary rehabilitation programme | Time taken to perform 5 sit-to-stand repetitions |
| Quadriceps maximal voluntary contraction force | Change from baseline after pulmonary rehabilitation programme | — |
| Chronic Respiratory Questionnaire | Change from baseline after pulmonary rehabilitation programme | — |
| Hospital Anxiety and Depression Scale | Change from baseline after pulmonary rehabilitation programme | — |
| COPD Assessment Test | Change from Baseline after pulmonary rehabilitation programme | — |
| Minute ventilation (VE) | Change from baseline (pre-exercise test) during and after test | — |
| Feeling Thermometer | Change from baseline after pulmonary rehabilitation programme | — |
| Oxygen consumption (VO2) | Change from baseline (pre-exercise test) during and after test | — |
| Carbon dioxide production (VCO2) | Change from baseline (pre-exercise test) during and after test | — |
| Blood oxygen saturation | Change from baseline (pre-exercise test) during and after test | — |
| Symptoms of exacerbations | Daily course over 3 months | The EXAcerbations of Chronic Pulmonary Disease Tool (EXACT) |
| Physical activity | Daily course over 3 months | As measured by a pedometer |
| Localisation | Daily course over 3 months | As measured by GPS information |
| Baseline Dyspnoea & Transition Dyspnoea Index | Change from baseline after pulmonary rehabilitation programme | — |
Countries
Switzerland
Outcome results
None listed