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临床试验/NCT01009099
NCT01009099已完成2 期

Reducing Dynamic Hyperinflation Through Breathing Retraining

US Department of Veterans Affairs2 个研究点 分布在 1 个国家目标入组 119 人开始时间: 2009年7月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
119
试验地点
2
主要终点
Exercise Duration (Time Walked on the Constant Workrate Treadmill Test)

研究概览

简要总结

This study will compare the effects of exercise training and breathing retraining (using metronome tones) to exercise training only. Exercise training lasts 12 weeks.

详细描述

Dynamic hyperinflation limits exercise tolerance in chronic obstructive pulmonary disease (COPD). To limit dynamic hyperinflation during exercise and thus improve exercise tolerance, we successfully developed a visual-auditory ventilation-feedback system. The system retrains patient's breathing pattern during exercise. The goal of the current proposal was to develop a user-friendly ventilation-feedback technique with a novel auditory feedback system. We reasoned that the proposed feedback system plus exercise training would be superior to exercise training alone while having the potential for an easier application into clinical practice. Hypotheses: The primary hypothesis is that the exercise duration of patients with moderate-to-severe COPD who successfully complete a 12-week program of breathing retraining plus exercise will be longer than that of patients who complete a 12-week program of treadmill exercise training alone. We also hypothesized that the primary predictor of improved exercise duration will be a reduction in dynamic hyperinflation and to a lesser extent, improvement in peripheral muscle function. Lastly, we hypothesize that dyspnea will be reduced in patients assigned to breathing retraining plus exercise when compared to exercise training alone. Methods: The proposed study was a randomized controlled clinical trial. 119 patients with moderate-to-severe COPD were randomized into breathing retraining plus exercise or exercise training alone. Both groups received 12-weeks of treadmill exercise training three times weekly. The breathing retraining plus exercise group also received auditory feedback to decrease respiratory rate and prolong exhalation. The goal of breathing retraining was to reduce exercise-induced dynamic hyperinflation. Follow-up testing was completed at 6, 12, and 24 weeks. Testing included a pulmonary function test, symptom-limited and constant workrate treadmill tests, six-minute walk, dyspnea measurements, testing of respiratory muscle strength and endurance, and quadriceps muscle endurance testing. Analysis: Measures of central tendency will be used to describe the study sample. A two-sample t-test ( = 0.05) was used to analyze changes from baseline to 12-weeks between the breathing retraining plus exercise group and exercise training alone group. In data analysis, intention-to-treat principles were used. Since several measures will be taken on each patient, mixed-models analysis will be used to compare changes over time between the two groups. Multiple regression analysis will be employed to determine the predictors of improved exercise performance.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
21 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 40 yr of age
  • FEV1/FVC < 70%
  • RV/TLC 120%
  • mean SpO2 90% at peak exercise (w/ or w/o O2)
  • Able to hear metronome sounds Lives near Hines, IL (Chicagoland area)

排除标准

  • Respiratory infection/exacerbation within the previous four weeks
  • Exercise limiting heart disease (+ stress test or other indicators of heart disease or complaints of angina during the stress test)
  • Primary asthma
  • Congestive heart failure (New York Heart Association Class III or IV)
  • Exercise-limiting peripheral arterial disease (stops exercise due to intermittent claudication)
  • Stops exercise due to arthritic pain in the knee or hips (self-report)
  • Inability to walk on the treadmill
  • Pregnancy
  • Any unforeseen illness or disability that would preclude exercise testing or training
  • Participation in a formal exercise program within the previous 12 weeks

结局指标

主要结局

Exercise Duration (Time Walked on the Constant Workrate Treadmill Test)

时间窗: baseline and 12 weeks

The primary outcome measure is a comparison of time walked on the constant workrate treadmill best at 12 weeks.

次要结局

未报告次要终点

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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