1-minute Sit-to-stand Test: A Multicentre Validation Study of a Simple Exercise Capacity Test in Patients With Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- 1-minute sit-to-stand test
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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)
干预措施: 1-minute sit-to-stand test (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)
干预措施: 1-minute sit-to-stand test (Other)
结局指标
主要结局
1-minute sit-to-stand test
时间窗: Change from baseline after pulmonary rehabilitation programme
Number of repetitions performed in the 1-minute sit-to-stand test
次要结局
- 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)