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

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ClinicalTrials.gov Identifier: NCT02441725
Recruitment Status : Completed
First Posted : May 12, 2015
Last Update Posted : October 25, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Other: 1-minute sit-to-stand test Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : April 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
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

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




Primary Outcome Measures :
  1. 1-minute sit-to-stand test [ Time Frame: Change from baseline after pulmonary rehabilitation programme ]
    Number of repetitions performed in the 1-minute sit-to-stand test


Secondary Outcome Measures :
  1. 5-repetition sit-to-stand test [ Time Frame: Change from baseline after pulmonary rehabilitation programme ]
    Time taken to perform 5 sit-to-stand repetitions

  2. 6-minute walk test [ Time Frame: Change from baseline after pulmonary rehabilitation programme ]
    Distance walked in 6 minutes

  3. Quadriceps maximal voluntary contraction force [ Time Frame: Change from baseline after pulmonary rehabilitation programme ]
  4. Chronic Respiratory Questionnaire [ Time Frame: Change from baseline after pulmonary rehabilitation programme ]
  5. Hospital Anxiety and Depression Scale [ Time Frame: Change from baseline after pulmonary rehabilitation programme ]
  6. COPD Assessment Test [ Time Frame: Change from Baseline after pulmonary rehabilitation programme ]
  7. Baseline Dyspnoea & Transition Dyspnoea Index [ Time Frame: Change from baseline after pulmonary rehabilitation programme ]
  8. Feeling Thermometer [ Time Frame: Change from baseline after pulmonary rehabilitation programme ]
  9. Oxygen consumption (VO2) [ Time Frame: Change from baseline (pre-exercise test) during and after test ]
  10. Carbon dioxide production (VCO2) [ Time Frame: Change from baseline (pre-exercise test) during and after test ]
  11. Respiratory exchange ratio (RER) [ Time Frame: Change from baseline (pre-exercise test) during and after test ]
  12. Minute ventilation (VE) [ Time Frame: Change from baseline (pre-exercise test) during and after test ]
  13. Heart Rate [ Time Frame: Change from baseline (pre-exercise test) during and after test ]
  14. Blood oxygen saturation [ Time Frame: Change from baseline (pre-exercise test) during and after test ]
  15. Symptoms of exacerbations [ Time Frame: Daily course over 3 months ]
    The EXAcerbations of Chronic Pulmonary Disease Tool (EXACT)

  16. Physical activity [ Time Frame: Daily course over 3 months ]
    As measured by a pedometer

  17. Localisation [ Time Frame: Daily course over 3 months ]
    As measured by GPS information



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02441725


Locations
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Switzerland
University of Zurich
Zurich, Switzerland, 8001
Sponsors and Collaborators
University of Zurich
Investigators
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Principal Investigator: Anja Frei, pHd University of Zurich, Epidemiology, Biostatistics and Prevention Institute
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02441725    
Other Study ID Numbers: STAND-UP Study
First Posted: May 12, 2015    Key Record Dates
Last Update Posted: October 25, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Lung Diseases
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Lung Diseases, Obstructive