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Clinical Trials/NCT02441725
NCT02441725CompletedNot Applicable

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

University of Zurich1 site in 1 country55 target enrollmentStarted: April 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
55
Locations
1
Primary Endpoint
1-minute sit-to-stand test

Study Overview

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 Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
40 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Pulmonary Rehabilitation Patients

Other

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)

Intervention: 1-minute sit-to-stand test (Other)

Acute Care Hospital Patients

Other

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)

Intervention: 1-minute sit-to-stand test (Other)

Outcomes

Primary Outcomes

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

  • Localisation(Daily course over 3 months)
  • Oxygen consumption (VO2)(Change from baseline (pre-exercise test) during and after test)
  • Symptoms of exacerbations(Daily course over 3 months)
  • 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)
  • 6-minute walk test(Change from baseline after pulmonary rehabilitation programme)
  • 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)
  • Heart Rate(Change from baseline (pre-exercise test) during and after test)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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