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

Not Applicable

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Other: 1-minute sit-to-stand test

• Registration Number: NCT02441725
• Lead Sponsor: University of Zurich

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.

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-29
• Study First Submitted QC: 2015-05-07
• Study First Posted: 2015-05-12
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-24
• Last Update Posted: 2016-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pulmonary Rehabilitation Patients	1-minute sit-to-stand test	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)
Acute Care Hospital Patients	1-minute sit-to-stand test	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)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Localisation	Daily course over 3 months	As measured by GPS information
Oxygen consumption (VO2)	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)
Hospital Anxiety and Depression Scale	Change from baseline after pulmonary rehabilitation programme
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
Blood oxygen saturation	Change from baseline (pre-exercise test) during and after test
Chronic Respiratory Questionnaire	Change from baseline after pulmonary rehabilitation programme
COPD Assessment Test	Change from Baseline after pulmonary rehabilitation programme
Feeling Thermometer	Change from baseline after pulmonary rehabilitation programme
5-repetition sit-to-stand test	Change from baseline after pulmonary rehabilitation programme	Time taken to perform 5 sit-to-stand repetitions
6-minute walk test	Change from baseline after pulmonary rehabilitation programme	Distance walked in 6 minutes
Quadriceps maximal voluntary contraction force	Change from baseline after pulmonary rehabilitation programme
Baseline Dyspnoea & Transition Dyspnoea Index	Change from baseline after pulmonary rehabilitation programme
Minute ventilation (VE)	Change from baseline (pre-exercise test) during and after test
Physical activity	Daily course over 3 months	As measured by a pedometer
Heart Rate	Change from baseline (pre-exercise test) during and after test

Trial Locations

Locations (1)

University of Zurich; 🇨🇭 Zurich, Switzerland