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临床试验/NCT01900873
NCT01900873已完成不适用

Effects of Inspiratory Muscle Training on Dyspnea Perception During Exercise in Patients With COPD

KU Leuven1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2013年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
KU Leuven
入组人数
20
试验地点
1
主要终点
Dyspnea (Borg CR-10 scale)

研究概览

简要总结

Patients with chronic obstructive pulmonary disease are often limited in their exercise capacity by intolerable shortness of breath (dyspnea). Patients are breathing at high lung volumes during exercise which forces inspiratory muscles to work at a high percentage of their maximal capacity. This increased inspiratory effort has been shown to be independently related to symptoms of dyspnea during exercise in previous research. Eight weeks of high intensity variable flow resistive inspiratory muscle training is hypothesized to reduce inspiratory effort and to decrease neural drive to inspiratory muscles. These factors are hypothesized to jointly contribute to delaying the occurrence of intolerable symptoms of dyspnea and to improve exercise tolerance in these patients.

详细描述

We want to study whether a highly intense inspiratory muscle training program improves exercise capacity by reducing inspiratory effort, improving pulmonary mechanics and delaying the development of intolerable symptoms of dyspnea during cycle exercise. Eight weeks of high intensity variable flow resistive inspiratory muscle training is hypothesized to reduce inspiratory effort and to decrease neural drive to inspiratory muscles. The ratio of inspiratory effort to volume displacement should improve, and reductions of inspiratory capacity during exercise should be delayed. These factors are hypothesized to jointly contribute in delaying the occurrence of intolerable symptoms of dyspnea and to improve exercise tolerance in these patients.

We will study physiological mechanisms by which inspiratory muscle training exerts its effects on dyspnea reduction and exercise capacity. In this clinical trial patients will be randomly allocated into either an intervention or a control group. The intervention group will receive a highly intense inspiratory muscle training program that will improve inspiratory muscle function. The control group will receive a sham training that will not result in physiological benefits.

During the 8-week training period patients will have to attend the hospital once weekly for a short visit to perform a training session under supervision. Before the training intervention patients will be assessed twice and then again once after the 8-week program. This means that this trial will involve a total of 11 visits (3 long visits (approximately 4h) for assessments and 8 short visits (approximately 30 minutes) for supervised training sessions) over a period of 2-3 months. Assessments of pulmonary function, inspiratory muscle function, exercise capacity, daily physical activity and symptoms of dyspnea during exercise will be performed. Pulmonary mechanics and inspiratory muscle activation during exercise will also be assessed.

Stable COPD patients with pronounced inspiratory muscle weakness (Pi,max < 70cmH2O or <70% predicted) will be eligible to participate in the study. Exclusion criteria will be diagnosed psychiatric or cognitive disorders, progressive neurological or neuromuscular disorders and severe orthopedic problems having a major impact on exercise capacity.

Patients in both the intervention and the placebo group will follow an eight-week IMT program. They will receive either high intensity IMT (intervention group) or sham IMT (placebo group). Interventions will be presented to patients as strength training (intervention group) or endurance training (placebo group). Measurements of primary and secondary endpoints will be performed before and after 8 weeks of IMT. All tests will be performed by an experienced investigator that will be blinded to group allocation.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical Diagnosis of COPD
  • Inspiratory Muscle Weakness (Pi,max < 70cmH2O or < 70% predicted)

排除标准

  • Major cardiovascular, orthopedic, or cognitive impairments limiting exercise capacity more than pulmonary function impairment.

结局指标

主要结局

Dyspnea (Borg CR-10 scale)

时间窗: Change from Baseline in Borg CR-10 scale at 8 weeks

Numerical value reported for intensity of dyspnea (shortness of breath) ranging from 0 (no symptoms) to 10 (maximal symptoms)

次要结局

  • Maximal inspiratory pressure (Pi,max)(Change from Baseline in Pi,max at 8 weeks)
  • Pulmonary Function(Change from Baseline in Pulmonary Function parameters at 8 weeks)
  • Daily Physical Activity(Change in daily steps and time in moderate to vigorous daily physical activity from Baseline at 8 weeks)
  • Health related Quality of Life(Change from Baseline in health related quality of life at 8 weeks)
  • Inspiratory Muscle Endurance during a constant load breathing task(Change from Baseline in endurance time at 8 weeks)
  • Endurance capacity during a constant load cycling exercise test(Change from Baseline in endurance time at 8 weeks)

研究者

发起方
KU Leuven
申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniel Langer

Postdoctoral Research Fellow Research Foundation Flanders

KU Leuven

研究点 (1)

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