Validation of the 1-minute Sit-to-stand Test in Patients With COPD (STAND-UP)

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

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Other: 1-minute sit-to-stand test

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 Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8001
    • University of Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Pulmonary Rehabilitation Patients; 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; Validation of the 1-minute sit-to-stand test in a COPD patient population
Other: Acute Care Hospital Patients; 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; Validation of the 1-minute sit-to-stand test in a COPD patient population

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Principal Investigator: Anja Frei, pHd, University of Zurich, Epidemiology, Biostatistics and Prevention Institute

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: April 29, 2015
• First Submitted That Met QC Criteria: May 7, 2015
• First Posted (Estimate): May 12, 2015

Study Record Updates

• Last Update Posted (Estimate): October 25, 2016
• Last Update Submitted That Met QC Criteria: October 24, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: STAND-UP Study