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临床试验/NCT02542826
NCT02542826Unknown不适用

Constant Rate Shuttle Walking and Stair Stepping Tests to Assess Exertional Dyspnea in COPD: Responsiveness to Pulmonary Rehabilitation and Minimal Clinically Important Difference

McGill University2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2015年8月最近更新:
适应症

试验速览

阶段
不适用
入组人数
80
试验地点
2
主要终点
Minimal clinically important difference (MCID) with regards to the change in breathlessness intensity ratings at the end of each of the 3-MST and 3-MWT.

研究概览

简要总结

This is a multi-site collaborative study that will be done in the context of three Quebec hospitals' outpatient pulmonary rehabilitation programs: Montreal Chest Institute; University of Laval, and Hopital Sacre-Coeur Montreal. The objectives are two-fold. First, to determine the Minimal Clinical Important Difference in intensity ratings of perceived breathlessness for each of the 3-min constant rate shuttle walking (3-MWT) and stair stepping (3-MST) protocols in patients with chronic obstructive pulmonary disease (COPD). Second, to test the hypothesis that both the 3-MWT and 3-MST protocols are able to detect statistically significant and clinically-meaningful improvements in exertional breathlessness following an 7-12 week outpatient rehabilitative exercise training program in COPD.

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
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or Female
  • Ambulatory
  • Moderate-to-very severe COPD (GOLD Stage 2-4)

排除标准

  • Respiratory exacerbation in the previous 6 weeks
  • Change in medication dosage/frequency in the previous 6 weeks
  • Clinical evidence of asthma
  • Cardiovascular and/or neuromuscular diseases that are unstable and/or that may contribute to exercise limitation
  • Any other contraindications to exercise training/testing

结局指标

主要结局

Minimal clinically important difference (MCID) with regards to the change in breathlessness intensity ratings at the end of each of the 3-MST and 3-MWT.

时间窗: Baseline and 7 weeks

次要结局

  • Change (post- minus pre- pulmonary rehab) in dyspnea intensity ratings on the Borg 0-10 ratio category scale(Baseline and 7 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dennis Jensen, Ph.D.

Assistant Professor

McGill University

研究点 (2)

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