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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2016

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.

Interventions

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

Arms, Groups and Cohorts

  • 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: 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)

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 5-repetition sit-to-stand test
    • Time Frame: Change from baseline after pulmonary rehabilitation programme
    • Time taken to perform 5 sit-to-stand repetitions
  • 6-minute walk test
    • Time Frame: Change from baseline after pulmonary rehabilitation programme
    • Distance walked in 6 minutes
  • Quadriceps maximal voluntary contraction force
    • Time Frame: Change from baseline after pulmonary rehabilitation programme
  • Chronic Respiratory Questionnaire
    • Time Frame: Change from baseline after pulmonary rehabilitation programme
  • Hospital Anxiety and Depression Scale
    • Time Frame: Change from baseline after pulmonary rehabilitation programme
  • COPD Assessment Test
    • Time Frame: Change from Baseline after pulmonary rehabilitation programme
  • Baseline Dyspnoea & Transition Dyspnoea Index
    • Time Frame: Change from baseline after pulmonary rehabilitation programme
  • Feeling Thermometer
    • Time Frame: Change from baseline after pulmonary rehabilitation programme
  • Oxygen consumption (VO2)
    • Time Frame: Change from baseline (pre-exercise test) during and after test
  • Carbon dioxide production (VCO2)
    • Time Frame: Change from baseline (pre-exercise test) during and after test
  • Respiratory exchange ratio (RER)
    • Time Frame: Change from baseline (pre-exercise test) during and after test
  • Minute ventilation (VE)
    • Time Frame: Change from baseline (pre-exercise test) during and after test
  • Heart Rate
    • Time Frame: Change from baseline (pre-exercise test) during and after test
  • Blood oxygen saturation
    • Time Frame: Change from baseline (pre-exercise test) during and after test
  • Symptoms of exacerbations
    • Time Frame: Daily course over 3 months
    • The EXAcerbations of Chronic Pulmonary Disease Tool (EXACT)
  • Physical activity
    • Time Frame: Daily course over 3 months
    • As measured by a pedometer
  • Localisation
    • Time Frame: Daily course over 3 months
    • As measured by GPS information

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Zurich
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Anja Frei, pHd, Principal Investigator, University of Zurich, Epidemiology, Biostatistics and Prevention Institute

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.