Validation of the 1-minute Sit-to-stand Test in Patients With COPD

Study Overview
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Brief Summary
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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
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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.

Official Title
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1-minute Sit-to-stand Test: A Multicentre Validation Study of a Simple Exercise Capacity Test in Patients With Chronic Obstructive Pulmonary Disease

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Other: 1-minute sit-to-stand test


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Pulmonary Rehabilitation Patients<br>Validation of the 1-minute sit-to-stand test; for participants who consent including a extended daily assessment period of physical activity and patient-reported symptoms of exacerbations: Male and female COPD inpatients (≥40 years of age) from two pulmonary rehabilitation clinics (Klinik Barmelweid and Zürcher Höhenklinik Wald) | Other: 1-minute sit-to-stand test<br>* Validation of the 1-minute sit-to-stand test in a COPD patient population<br>|
| Other: Acute Care Hospital Patients<br>Validation of the 1-minute sit-to-stand test, including daily assessment of physical activity and patient-reported symptoms of exacerbations: Male and female COPD inpatients from two acute care hospitals (≥40 years of age; Stadtspital Waid and Spital Uster) | Other: 1-minute sit-to-stand test<br>* Validation of the 1-minute sit-to-stand test in a COPD patient population<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1-minute sit-to-stand test | Number of repetitions performed in the 1-minute sit-to-stand test | Change from baseline after pulmonary rehabilitation programme | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5-repetition sit-to-stand test | Time taken to perform 5 sit-to-stand repetitions | Change from baseline after pulmonary rehabilitation programme | 
| 6-minute walk test | Distance walked in 6 minutes | Change from baseline after pulmonary rehabilitation programme | 
| 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 | 
| Baseline Dyspnoea & Transition Dyspnoea Index |  | Change from baseline after pulmonary rehabilitation programme | 
| 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 | 
| Respiratory exchange ratio (RER) |  | Change from baseline (pre-exercise test) during and after test | 
| Minute ventilation (VE) |  | Change from baseline (pre-exercise test) during and after test | 
| Heart Rate |  | 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 | The EXAcerbations of Chronic Pulmonary Disease Tool (EXACT) | Daily course over 3 months | 
| Physical activity | As measured by a pedometer | Daily course over 3 months | 
| Localisation | As measured by GPS information | Daily course over 3 months |