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Completed

NCT Number: NCT02441725

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

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.

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Zurich

Zurich, 8001, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

1-minute sit-to-stand test

Other

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

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

Acronym: STAND-UP

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 12, 2015
Registry last updated
Oct 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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