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临床试验/NCT04033783
NCT04033783已完成不适用

The Impact of Walking Behind the Patient on Six-Minute Walk Test Distance in Chronic Obstructive Pulmonary Disease: a Randomized Cross-over Study

University of Zurich4 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2019年9月18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
49
试验地点
4
主要终点
Exercise capacity

研究概览

简要总结

The six-minute walk test (6MWT) is a well established field exercise test to assess the functional exercise capacity in chronic obstructive pulmonary disease (COPD). The objective of this study is to assess the impact of walking behind the patient on 6MWT distance in patients with COPD.

详细描述

In a single-center, randomized crossover study, the investigators aim to elucidate whether there is a difference in the 6MWT distance when the assessor walks behind the patient compared to the patient walking alone.

Patients with COPD referred for pulmonary rehabilitation will be invited to perform an accompanied 6MWT (assessor walks behind the patient) and unaccompanied 6MWT (assessor does not walk behind the patient) in random order.

The tests will be performed at the end of a pulmonary rehabilitation program, after patients are familiarised with the 6MWT testing procedure and learning effects can be excluded.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with a diagnosis of COPD according to GOLD II-IV (FEV1/FVC < 0.7, FEV1%Norm < 80%)

排除标准

  • Inability to perform a 6MWT when arriving at the clinic (e.g., lower limb joint surgery within preceding 3 months, unstable cardiac disease, predominant neurological limitations)
  • Inability to understand the instructions of the 6MWT, either of language or cognitive reasons

结局指标

主要结局

Exercise capacity

时间窗: During pulmonary rehabilitation, approximately 14 days

Difference in six minute walk test distance between the two experimental conditions (in meter)

次要结局

  • Six minute walk test(During pulmonary rehabilitation, approximately 14 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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