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临床试验/NCT04767126
NCT04767126已完成不适用

Impact of Pulmonary Rehabilitation on Peripheral Skeletal Muscle Function in Patients With Chronic Obstructive Pulmonary Disease.

Fondazione Don Carlo Gnocchi Onlus1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年1月13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
20
试验地点
1
主要终点
Lower limbs muscle power

研究概览

简要总结

Chronic obstructive pulmonary disease (COPD) is characterized by irreversible airway obstruction and progressive deterioration of respiratory function. Patients with COPD show a limited exercise tolerance, early fatigability and progressive dyspnea, with important consequences on the ability to sustain even mild efforts and a drastic restriction in the activities of daily living. Muscle dysfunction is a systemic manifestation of COPD that contributes to exertion intolerance in individuals with COPD to the point of compromising fundamental functional activities, such as walking. Previous studies have shown, in fact, that quadriceps strength can be reduced by 20% to 30% in patients with COPD and this value is associated with an increased risk of mortality in patients with lower strength levels. In addition, loss of muscle mass or sarcopenia also occurs with a prevalence of between 8% and 67% in patients with COPD, exacerbating the picture of muscle dysfunction.

One of the goals of respiratory rehabilitation is precisely the prevention of muscle dysfunction in patients with COPD. However, rehabilitation programs aimed at maintaining and recovering muscle strength are often lacking in guidance regarding target muscles, duration of sessions, and training intensity, while strength assessment is often limited by the timing and resources associated with the clinical setting in which it takes place. This makes it difficult to determine its short- and long-term effectiveness.

Therefore, assessment of muscle function in patients with COPD requires tests that are simple and quick to perform, but equally capable of providing quantitative data referable to a specific characteristic of muscle strength as well as indicative of the patient's overall function. In addition, complementary measurements such as body composition and muscle mass, as well as the development of predictive models and normative values of muscle function could provide additional information on the progression of muscle dysfunction in patients with COPD, allowing rehabilitation intervention to be directed toward recovery of the most compromised functions.

Therefore, the aims of this study are: 1) To evaluate the effectiveness of a standard pulmonary rehabilitation program in recovering peripheral muscle dysfunction in patients with COPD. 2) To evaluate the clinical reliability of tests commonly used to measure peripheral muscle function in the rehabilitation setting of patients with COPD.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • COPD diagnosis (GOLD stage: II-III-IV), defined as post-bronchodilator forced expiratory volume in 1s (FEV1)/forced vital capacity < 0.7 and FEV1 < 80% predicted.

排除标准

  • Restrictive lung disease, unstable conditions, recent exacerbation, infection, embolism, pneumothorax, thoracic or abdominal surgery (less than 3 months before recruitment).
  • Cardiologic conditions like myocardial infarction (less than 6 months before recruitment), heart failure, or severe angina.
  • Inability of perform the exercise training (e.g. orthopaedic conditions).
  • Incapability to understand the instructions required to carry out the tests and assessments planned.

结局指标

主要结局

Lower limbs muscle power

时间窗: Change after 3 months from study completion

Muscle power of the lower limbs measured during the sit-to-stand test

次要结局

未报告次要终点

研究者

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

Simone Pancera

PhD(s)

Fondazione Don Carlo Gnocchi Onlus

研究点 (1)

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