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临床试验/NCT02955108
NCT02955108已完成不适用

The Effect of Distractive Auditory Stimuli (Music) on Dyspnea and Anxiety During Exercise in Adults With Chronic Respiratory Disease

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2017年10月27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
8
试验地点
1
主要终点
Dyspnea Intensity (DI)

研究概览

简要总结

The objective of this study is to look at the effects of distractive auditory stimuli (DAS) on reducing dyspnea intensity and related anxiety and increasing exercise tolerance. Investigators hope that compared to a no-music control condition, that under a music condition participants with COPD will (a) demonstrate increased self-paced walk distance and enjoyment; (b) have less dyspnea intensity, (c) experience less dyspnea anxiety; (d) have less fatigue and state anxiety; and (e) higher maximum heart rate. The upbeat music with a tempo of 90 - 100 bpm (an average-to-moderate walking tempo) is expected to have distractive and performance enhancing effects in order to increase tolerance to dyspnea and exercise. The long-term goal of this study is to increase physical activity in adults with COPD and RLD by promoting dyspnea and fatigue management through use of distractive auditory stimuli in the form of music.

详细描述

This randomized clinical trial will use a cross-over design. The research will include two within-subject factors, music versus no music and time. Each subject will be randomized a single time to receive either music first then no music, or alternatively, no music first then music during two walk tests.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
Double (Participant, Investigator)

入排标准

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

入选标准

  • English speaking
  • aged 40 years or older, with physician-diagnosed COPD
  • a flow volume loop with a FEV1/FVC of < 0.70 in the past 12 months
  • medically cleared to participate in NYULMC's pulmonary rehabilitation program.

排除标准

  • Inability to exercise due to musculoskeletalor neurological dysfunction
  • Inability to walk independently (unaided)
  • deafness or severe hearing impairment requiring hearing aids
  • mMRC score = 0 ("I only get breathlessness with strenuous exercise").

结局指标

主要结局

Dyspnea Intensity (DI)

时间窗: 60 Minutes

Borg Breathlessness Scale. The Borg dyspnea scale is a single-item rating scale, ranging between 0, "nothing at all", and 10, "very, very severe (maximal)". Patients will be asked to rate their level of dyspnea during the walk test using the 10-point Borg scale after the 6MWT.64 Validity of the Borg scale for measuring dyspnea intensity has been shown.65

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 (1)

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