Overview

This trial has been completed.

Condition pulmonary disease, chronic obstructive
Treatment 1-minute sit-to-stand test
Sponsor University of Zurich
Start date April 2015
End date May 2016
Trial size 55 participants
Trial identifier NCT02441725, STAND-UP Study

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Other)
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)
1-minute sit-to-stand test
Validation of the 1-minute sit-to-stand test in a COPD patient population
(Other)
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)
1-minute sit-to-stand test
Validation of the 1-minute sit-to-stand test in a COPD patient population

Primary Outcomes

Measure
1-minute sit-to-stand test
time frame: Change from baseline after pulmonary rehabilitation programme

Secondary Outcomes

Measure
5-repetition sit-to-stand test
time frame: Change from baseline after pulmonary rehabilitation programme
6-minute walk test
time frame: Change from baseline after pulmonary rehabilitation programme
Quadriceps maximal voluntary contraction force
time frame: Change from baseline after pulmonary rehabilitation programme
Chronic Respiratory Questionnaire
time frame: Change from baseline after pulmonary rehabilitation programme
Hospital Anxiety and Depression Scale
time frame: Change from baseline after pulmonary rehabilitation programme
COPD Assessment Test
time frame: Change from Baseline after pulmonary rehabilitation programme
Baseline Dyspnoea & Transition Dyspnoea Index
time frame: Change from baseline after pulmonary rehabilitation programme
Feeling Thermometer
time frame: Change from baseline after pulmonary rehabilitation programme
Oxygen consumption (VO2)
time frame: Change from baseline (pre-exercise test) during and after test
Carbon dioxide production (VCO2)
time frame: Change from baseline (pre-exercise test) during and after test
Respiratory exchange ratio (RER)
time frame: Change from baseline (pre-exercise test) during and after test
Minute ventilation (VE)
time frame: Change from baseline (pre-exercise test) during and after test
Heart Rate
time frame: Change from baseline (pre-exercise test) during and after test
Blood oxygen saturation
time frame: Change from baseline (pre-exercise test) during and after test
Symptoms of exacerbations
time frame: Daily course over 3 months
Physical activity
time frame: Daily course over 3 months
Localisation
time frame: Daily course over 3 months

Eligibility Criteria

Male or female participants at least 40 years old.

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

Additional Information

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
Principal investigator Anja Frei, pHd
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by University of Zurich.