Clinical trial NCT02441725: Validation of the 1-minute Sit-to-stand Test in Patients With COPD
Official title: 1-minute Sit-to-stand Test: A Multicentre Validation Study of a Simple Exercise Capacity Test in Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2015-05-12
Enrollment: 55
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: 1-minute sit-to-stand test
timeFrame: Change from baseline after pulmonary rehabilitation programme
Secondary outcomes:
measure: 5-repetition sit-to-stand test
timeFrame: Change from baseline after pulmonary rehabilitation programme
measure: 6-minute walk test
timeFrame: Change from baseline after pulmonary rehabilitation programme
measure: Quadriceps maximal voluntary contraction force
timeFrame: Change from baseline after pulmonary rehabilitation programme
measure: Chronic Respiratory Questionnaire
timeFrame: Change from baseline after pulmonary rehabilitation programme
measure: Hospital Anxiety and Depression Scale
timeFrame: Change from baseline after pulmonary rehabilitation programme
measure: COPD Assessment Test
timeFrame: Change from Baseline after pulmonary rehabilitation programme
measure: Baseline Dyspnoea & Transition Dyspnoea Index
timeFrame: Change from baseline after pulmonary rehabilitation programme
measure: Feeling Thermometer
timeFrame: Change from baseline after pulmonary rehabilitation programme
measure: Oxygen consumption (VO2)
timeFrame: Change from baseline (pre-exercise test) during and after test
measure: Carbon dioxide production (VCO2)
timeFrame: Change from baseline (pre-exercise test) during and after test
measure: Respiratory exchange ratio (RER)
timeFrame: Change from baseline (pre-exercise test) during and after test
measure: Minute ventilation (VE)
timeFrame: Change from baseline (pre-exercise test) during and after test
measure: Heart Rate
timeFrame: Change from baseline (pre-exercise test) during and after test
measure: Blood oxygen saturation
timeFrame: Change from baseline (pre-exercise test) during and after test
measure: Symptoms of exacerbations
timeFrame: Daily course over 3 months
measure: Physical activity
timeFrame: Daily course over 3 months
measure: Localisation
timeFrame: Daily course over 3 months
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University of Zurich
Study officials:
affiliation: University of Zurich
name: Anja Frei, pHd
role: PRINCIPAL_INVESTIGATOR
References: