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

Pulmonary Disease, Chronic Obstructive Clinical Trial

— STAND-UP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02441725
• Other study ID #: STAND-UP Study
• Status: Completed
• Phase: N/A
• First received: April 29, 2015
• Last updated: October 24, 2016
• Start date: April 2015
• Est. completion date: May 2016

Study information

• Verified date: October 2016
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• 1-minute sit-to-stand test
Validation of the 1-minute sit-to-stand test in a COPD patient population

Locations

Country	Name	City	State
Switzerland	University of Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	5-repetition sit-to-stand test	Time taken to perform 5 sit-to-stand repetitions	Change from baseline after pulmonary rehabilitation programme	No
Secondary	6-minute walk test	Distance walked in 6 minutes	Change from baseline after pulmonary rehabilitation programme	No
Secondary	Quadriceps maximal voluntary contraction force		Change from baseline after pulmonary rehabilitation programme	No
Secondary	Chronic Respiratory Questionnaire		Change from baseline after pulmonary rehabilitation programme	No
Secondary	Hospital Anxiety and Depression Scale		Change from baseline after pulmonary rehabilitation programme	No
Secondary	COPD Assessment Test		Change from Baseline after pulmonary rehabilitation programme	No
Secondary	Baseline Dyspnoea & Transition Dyspnoea Index		Change from baseline after pulmonary rehabilitation programme	No
Secondary	Feeling Thermometer		Change from baseline after pulmonary rehabilitation programme	No
Secondary	Oxygen consumption (VO2)		Change from baseline (pre-exercise test) during and after test	No
Secondary	Carbon dioxide production (VCO2)		Change from baseline (pre-exercise test) during and after test	No
Secondary	Respiratory exchange ratio (RER)		Change from baseline (pre-exercise test) during and after test	No
Secondary	Minute ventilation (VE)		Change from baseline (pre-exercise test) during and after test	No
Secondary	Heart Rate		Change from baseline (pre-exercise test) during and after test	No
Secondary	Blood oxygen saturation		Change from baseline (pre-exercise test) during and after test	No
Secondary	Symptoms of exacerbations	The EXAcerbations of Chronic Pulmonary Disease Tool (EXACT)	Daily course over 3 months	No
Secondary	Physical activity	As measured by a pedometer	Daily course over 3 months	No
Secondary	Localisation	As measured by GPS information	Daily course over 3 months	No