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临床试验/NCT04903704
NCT04903704已完成不适用

Pulmonary HypERtenSion and Measurement of Exercise caPacIty REmotely: the PERSPIRE Study

Sheffield Teaching Hospitals NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2021年6月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
75
试验地点
2
主要终点
Sit to stand repititions

研究概览

简要总结

Background

Hospital-based walking exercise tests are routinely used in patients with pulmonary hypertension to assess functional ability and disease progression over time. We are seeing a greater emphasis on non-face-to-face clinical assessments, where such tests cannot be conducted. It is important to identify alternative tests which can be which can be conducted by patients at home and used to support clinical decision making.

Aim

To test the safety of the 1-minute sit-to-stand test in patients with pulmonary hypertension and its comparability with hospital-based walking exercise tests.

Methods

A sample of 75 patients attending hospital appointments will carry out an Incremental Shuttle Walk Test, followed by a 1-minute sit-to-stand test after a 30 minute rest. Data will be analysed for safety and comparability between the 2 tests.

In the event of favourable findings (safety and comparability) from the hospital-based testing, a further sample of patients will be asked to perform the 1-minute sit-to-stand test in the home setting

详细描述

Pulmonary hypertension (PH) is a progressive condition affecting the circulation to the lungs from the heart. It is a rare condition and Sheffield Pulmonary Vascular Diseases Unit (SPVDU) is the largest of 7 adult specialist pulmonary hypertension centres, caring for 1900 patients, or 30% of the pulmonary hypertension patients treated in the UK. Measures of how well patients tolerate exercise and their functional abilities are widely established in pulmonary hypertension. This includes hospital-based assessments such as Incremental Shuttle Walk Test (ISWT - a "beep" test which requires patients to walk progressively faster until they cannot continue) and 6 minute walking test (how far patients can walk in 6 minutes), which are included in international risk guidelines for PH. At SPVDU patients attend clinic appointments at intervals ranging from 3 -12 months; an ISWT is conducted at every clinic visit and the results are used to monitor functional progress over time.

This study will seek to establish the safety of the 1-minute sit-to-stand test and its comparability to the Incremental Shuttle Walk Test. Participants will be recruited as part of their standard clinic visit to SPVDU. They will undergo their standard clinical Incremental Shuttle Walk Test. This test is a standard of clinical care and its essential to the patient assessment on their clinical visit and will therefore be conducted first in all cases. They will be allowed a 30 minute rest before undertaking the 1-minute sit-to-stand test.

It is standard at SPVDU that patients undertake the Incremental Shuttle Walk Test without supplemental oxygen - standardised protocols allow for this if repeat tests follow the same procedure. Patients are advised that they should stop the activity when they feel they can no longer continue. The same protocol will be adopted for the 1-minute sit-to-stand test.

Clinical observations (heart rate, blood pressure, oxygen saturations) will be taken before and after both tests. Heart rate and oxygen saturations will be monitored during both tests. Patient reported measures of breathlessness and perceived exertion will be recorded on completion of both tests.

Adverse events e.g. dizziness, syncope or the participant becoming unwell be recorded. Adverse event data will be monitored and analysed to determine the safety of the 1MSTS test. To assist in the planning or potential next stages of the study, participants will be asked if they have access to equipment that would support home monitoring e.g. tape measure, BP monitor, pulse oximeter, weighing scales, video calling.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosis of pulmonary arterial hypertension (PAH) or chronic thromboembolic pulmonary hypertension (CTEPH)

排除标准

  • mobility significantly impaired by musculoskeletal or neurological co-morbidities; learning difficulties or cognitive impairment that would prohibit informed consent

结局指标

主要结局

Sit to stand repititions

时间窗: Counted during testing

The number of completed sit to stand repetitions in 1 minute

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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