跳至主要内容
临床试验/NCT05630092
NCT05630092已完成不适用

Comparison of the Standard 6-Minute Maximal Speed Walk Test Against a 6-Minute Normal Speed Walk Test as an Alternative and More Accurate Assessment for Ambulatory Oxygen Requirement.

Hampshire Hospitals NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 93 人开始时间: 2023年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
93
试验地点
1
主要终点
Average drop in SpO2 from baseline to nadir

研究概览

简要总结

Patients with lung disease who report breathlessness on exertion are often referred for a 6MWT. Due to the nature of the 6MWT (hereon referred to as a Max-6MWT), patients are required to walk as far as they can in 6 minutes. This may lead to an inaccurate assessment of their requirement for ambulatory oxygen as this form of exercise may not correspond to their normal daily activities.

In this study, patients who are routinely referred for a Max-6MWT to investigate possible exercise-induced hypoxaemia will be invited to perform an additional walking test which is performed at their normal walking speed, referred here on in as a Nor_6MWT. We hypothesise that performing a Nor_6MWT will provide a more accurate assessment of a patients' oxygen requirement, primarily from their oxygen desaturation during the test.

详细描述

Patients with lung disease who report breathlessness on exertion are often referred for a 6MWT. During this test patients are asked to walk up and down a corridor (or other flat area) for six minutes whilst their blood oxygen levels and heart rate are non-invasively measured using a pulse oximeter (finger probe) and the distance walked is measured. In addition, a questionnaire that obtains a Borg Score measures the patients perceived breathlessness and leg muscle fatigue both before and immediately following the test.

Due to the nature of the 6MWT (hereon referred to as a Max-6MWT), patients are required to walk as far as they can in 6 minutes. This may lead to an inaccurate assessment of their requirement for ambulatory oxygen as this form of exercise may not correspond to their normal daily activities. It may also not accurately measure the normal changes in oxygen saturation (or desaturation) that occurs in these patients during their normal daily activities (such as walking to the shops, walking up the stairs, gardening).

In this study, patients who are routinely referred for a Max-6MWT to investigate possible exercise-induced hypoxaemia will be invited to perform an additional walking test which is performed at their normal walking speed, referred here on in as a Nor_6MWT. We hypothesise that performing a Nor_6MWT will provide a more accurate assessment of a patients' oxygen requirement, primarily from their oxygen desaturation during the test.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Health Services Research
盲法
Single (Care Provider)

盲法说明

Results from the modified walk test will not be provided to the medical team prescribing ambulatory oxygen assessment.

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Referred for a standard 6-minute walk test
  • Has the capacity to give informed consent
  • Is aged between 18 and 90

排除标准

  • Lack of capacity to provide informed consent
  • Poor peripheral perfusion that prevents an accurate measurement of SpO2
  • Contraindicated to perform a Max_6MWT as indicated in the standard HHFT 6MWT SO

研究组 & 干预措施

Normal then Maximal Speed Walk Test

Active Comparator

Normal speed walking test (Nor_6MWT) followed by Maximal speed walking test (Max_6MWT)

干预措施: Maximal 6-minute Walk Test (Max_6MWT) (Diagnostic Test)

Maximal then Normal Speed Walk Test

Active Comparator

Maximal speed walking test (Max_6MWT) followed by normal speed walking test (Nor_6MWT).

干预措施: Maximal 6-minute Walk Test (Max_6MWT) (Diagnostic Test)

Maximal then Normal Speed Walk Test

Active Comparator

Maximal speed walking test (Max_6MWT) followed by normal speed walking test (Nor_6MWT).

干预措施: Normal speed 6-minute Walk Test (Nor_6MWT) (Diagnostic Test)

Normal then Maximal Speed Walk Test

Active Comparator

Normal speed walking test (Nor_6MWT) followed by Maximal speed walking test (Max_6MWT)

干预措施: Normal speed 6-minute Walk Test (Nor_6MWT) (Diagnostic Test)

结局指标

主要结局

Average drop in SpO2 from baseline to nadir

时间窗: During the walk test

Continuous monitoring of SpO2 will allow for the measurement in the drop from baseline to the lowest point (nadir) during the test. Between the walk tests, the average drop will be calculated and compared.

Average Drop in SpO2 From Baseline to Nadir

时间窗: During the walk test

Continuous monitoring of SpO2 will allow for the measurement in the drop from baseline to the lowest point (nadir) during the test. Between the walk tests, the average drop will be calculated and compared.

次要结局

  • Is there a difference in the absolute nadir SpO2 between maximal and normal walking.speed?(During the walk test)
  • Is there a difference in the time taken to reach nadir in SpO2?(During the walk test)
  • Is There a Difference in the Time Taken to Reach Nadir in SpO2?(During the walk test)
  • Is There a Difference in the Nadir SpO2 (%) Between Maximal and Normal Walking Speed?(During the walk test)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验