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临床试验/NCT04541511
NCT04541511已完成不适用

Comparison of the 6-minute Walking Test in a Corridor and on a Non-motorized Treadmill, Feasibility Study

Hopital Foch2 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2020年8月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Hopital Foch
入组人数
9
试验地点
2
主要终点
To assess the equivalence of walking distances obtained with the 6-minute walk test on a non-motorized treadmill to the baseline (6-WT on a corridor) test in healthy subjects.

研究概览

简要总结

Evaluation of the equivalence of 6-minute walking test performed on a non-motorized treadmill to the reference test : a 6-minute walking test on a corridor.

详细描述

The Six-Minute Walk Test (6-WT) is a standardized test to assess a person's functional ability to walk as far as they can in six minutes. It is widely used in the assessment of functional disability in response to medical intervention in respiratory and cardiac conditions.

This test requires a corridor measuring between 20 and 30 metres and does not require any special technical equipment or training.

While the test appears simple to set up, factors such as the length or width of the corridor, and external disruptive elements, may affect the results. Indeed, the configuration of the test site plays a role in the test result. For example, the distance traveled in a 6-minute walking test is greater on a continuous circuit than in a lane that requires people to walk back and forth or when others are using the lane (zigzags, slowdowns). In a hospital setting, while it is easy to find a corridor that is long enough, it is not always possible to dedicate it exclusively to walking tests.

An alternative would be to perform this test on a non-motorized treadmill to avoid these biases. The main objective of this study is to evaluate the equivalence of a 6-minute walking test performed on a non-motorized treadmill to the reference test in healthy subjects. In addition, a small number of patients will be invited to perform a 6-minute CT scan on a non-motorized treadmill in order to first evaluate the perception and acceptability of this new method in this population (seniors, pathologies). If the results are conclusive, a similar study with patients only will be performed.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
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

  • Healthy subject 18 years of age or older
  • Have signed a consent form
  • Be affiliated with a Health Insurance Plan
  • Having a pathology requiring the monitoring of the evolution of the distance performed by 6-WT (patients only)

排除标准

  • Being unable to walk for several minutes for physical, neurological or psychological reasons
  • Recent acute coronary syndrome
  • Rest tachycardia greater than 120 pulses/min.
  • Resting blood pressure greater than 180/100 mmHg
  • Pregnant, Parturient or Nursing Women
  • Persons deprived of liberty: minors or adults who are subject to a legal protection measure or who are unable to express their consent.
  • Subjects under guardianship or curatorship.

结局指标

主要结局

To assess the equivalence of walking distances obtained with the 6-minute walk test on a non-motorized treadmill to the baseline (6-WT on a corridor) test in healthy subjects.

时间窗: [length on the test - 1 day]

Total distance on the 6-WT on a corridor and on a non-motorized treadmill in healthy subjects.

次要结局

  • Evaluate the change in heart rate during the two test methods in healthy subjects([length on the test - 1 day])
  • Evaluate the change in oxygen saturation during the two test methods in healthy subjects.([length on the test - 1 day])
  • To measure the perception of exertion after both test methods in healthy subjects.([length on the test - 1 day])
  • Evaluate patients' perception of the use of the new method.([length on the test - 1 day])

研究者

发起方
Hopital Foch
申办方类型
Other
责任方
Sponsor

研究点 (2)

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