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临床试验/NCT03644888
NCT03644888已完成不适用

Effects of Continuous Chest Wall Vibration on Dyspnea and Exercise Tolerance in COPD Patients

Fondazione Don Carlo Gnocchi Onlus2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年9月12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
40
试验地点
2
主要终点
Change of exercise tolerance

研究概览

简要总结

Dyspnea, the sensation of breathing discomfort or shortness of breath, is one of the main symptoms for patients affected by Chronic Obstructive Pulmonary Disease (COPD), particularly during exercise. Previous study show that chest wall vibration decrease dyspnea in COPD patients and precisely when applied during the inspiration phase, called "in-phase vibration" (IPV) which provide vibration directly on intercostal muscles. These findings have been obtained in laboratory context and the intercostals muscles vibration has been tested only in single phases of breathing, during inspiration with IPV and during exhalation with out-of-phase vibration (OPV). None study has evaluated the effect of a continuous chest wall vibration (CCWV), namely muscles vibration during the whole cycle of breathing, on dyspnea in patients with COPD in a clinical context. Continuous high frequency vibration has been proven to reduce myoelectrical manifestation of fatigue, probably modifying the centrally driven motor unit recruitment hierarchy, in healthy subjects.

Moreover, CCWV is a modality of provide vibration more suitable and cost-effective in a clinical context than single-phases vibration that requires specific instruments for the detection of breathing phases and the coupling with vibration device.

On these bases, the investigators hypothesized that CCWV at high frequency, applied during a cycle ergometer training program, could decrease dyspnea and enhance the exercise tolerance in COPD patients. Therefore, the aim of this study is to evaluate the effects of high frequency CCWV on dyspnea and exercise tolerance in patients with COPD patients compared to usual care and to sham intervention.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • COPD diagnosis (GOLD stage: 2-3-4)

排除标准

  • Restrictive lung disease
  • Active pulmonary infection
  • Pulmonary embolism (less than 3 months)
  • Pneumotorax
  • Thoracic/abdominal operation (less than 3 months)
  • Myocardial infarction (less than 6 months)
  • Congestive heart failure/ heart failure/ right heart failure
  • Angina/severe angina
  • Incapability of perform the cycle ergometer training (e.g. orthopaedic or urogenital conditions)
  • Incapability to understand the intructions required to carry out the tests and assessments planned

结局指标

主要结局

Change of exercise tolerance

时间窗: Change from Baseline exercise tolerance at 4 weeks

Six Minutes Walking Test. This test assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance. Higher values represent a better outcome

Change of Dyspnea

时间窗: Change from Baseline Barthel Index based on dyspnea at 4 weeks

Barthel Index based on dyspnea. The scale measures the level of dyspnea perceived in performing basic daily living activities, Range: 0 - 100 Higher values represent a worse outcome

次要结局

  • Change of Risk of death(Change from Baseline risk of death at 4 weeks)
  • Change of Sympatho-vagal balance(Change from Baseline sympatho-vagal balance at 2 weeks and at 4 weeks)
  • Change of respiratory muscles strength(Change from Baseline respiratory muscles strength at 4 weeks)
  • Change of Health-related quality of life(Change from Baseline health-related quality at 4 weeks)

研究者

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

Riccardo Buraschi

Principal Investigator

Fondazione Don Carlo Gnocchi Onlus

研究点 (2)

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