Feasibility and Validity of Remote Exercise Testing in Patients With Pulmonary Hypertension
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Cross-sectional assessment of novel exercise test validity (part 1)
研究概览
简要总结
The investigators plan to investigate the feasibility and validity of tests of exercise capacity, when these are performed in hospital and at home, by patients who are diagnosed with pulmonary hypertension.
Patients with pulmonary hypertension develop high blood pressure within the lungs, leading to a limitation in the amount of exercise they are able to perform. At diagnosis and follow-up patients routinely perform short exercise tests which are performed under supervision in the clinic or hospital. The results from these are compared over time and are used to assess how stable patients are. Currently, patients are required to travel to hospital to perform such a test and thus telephone or video appointments do not include this information. This study aims to investigate a range of exercise tests to assess whether they are valid in pulmonary hypertension (whether the results are comparable to the results from the current exercise test performed in hospital, the six-minute walk test) and whether it is feasible for patients to to perform these tests at home.
The investigators aim to investigate four different home exercise tests, including a sit-to-stand test, a timed up and go test, a six-minute walk test and a step test. The investigators will ask patients to perform these tests in a hospital environment and at home on two occasions. The results of these will be compared to see how they change over time and will be compared to other results obtained during standard care. Additionally, patients will be asked a questionnaire to assess their views on the four tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
Exercise study
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 16-years-old and above
- •Diagnosed with pulmonary hypertension from any ERS/ESC group
- •Able to give informed consent
排除标准
- •Unable to provide consent
- •Restricted so as unable to perform a standard 6MWT, either due to mobility or symptoms
- •Patients feel they would be unable to perform any of the 4 study tests when at home
- •Concerns about the patient's safety of performing home-based exercise tests (as decided by the consenting clinician and/or the patient)
研究组 & 干预措施
Exercise
干预措施: Exercise Testing (Diagnostic Test)
结局指标
主要结局
Cross-sectional assessment of novel exercise test validity (part 1)
时间窗: 2 years
During the inpatient hospital visit (visit 1), correlation will be analysed between the distance (metres) walked on a six-minute walk test and the outcome of each of the study tests (as listed below). 1. TUG - time (seconds) 2. T6MWT - distance (metres) 3. STS - number of steps 4. ST - distance (metres) Correlation will be measured by Pearson's R Calculator for parametric data and Spearman's Rho for non-Parametric data.
Cross-sectional assessment of novel exercise test validity (part 2)
时间窗: 2 years
Agreement will be analysed between each of study tests when performed during visit 1 (inpatient hospital visit) and when performed during visit 2 (within 7 days of being discharged from hospital). This will be performed with Bland-Altman analysis.
Longitudinal study of feasibility
时间窗: 2 years
Proportion of patients that completed each of the allocated tests at visit 2 and at visit 3 (3 months after being discharged from hospital).
Longitudinal study of validity
时间窗: 2 years
Concordance of change will be analysed between each of study tests when performed during visit 2 (and when performed during visit 3. This degree of change will be compared against the patients standard six minute walk test result when measured at visit 1 and visit 3.
次要结局
未报告次要终点