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临床试验/NCT03117764
NCT03117764已完成不适用

The 1-minute-sit-to-stand Test is Practical to Assess and Follow the Muscle Weakness in Cystic Fibrosis.

Cliniques universitaires Saint-Luc- Université Catholique de Louvain2 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2017年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
81
试验地点
2
主要终点
Change from peripheral muscular strength at 14 days.

研究概览

简要总结

The investigators know that peripheral muscle weakness and exercise intolerance are prevalent (56%) in cystic fibrosis (Trooster et al, 2009). Physical inactivity is likely to be an important underlying factor. Those conditions are associated with a poor prognosis (Nixon et al, 1992). The effect of intravenous antibiotherapy on peripheral muscle and physical activity remains unclear.

The aim of the study is to evaluate the impact of intravenous antibiotherapy on peripheral muscular strength in patients with cystic fibrosis (adults and children) who receive intravenous antibiotherapy for an acute exacerbation or electively (decline in lung function without exacerbation).

详细描述

Background Peripheral muscle weakness and exercise intolerance are prevalent (56%) in cystic fibrosis (Trooster et al, 2009). Physical inactivity is likely to be an important underlying factor. Those conditions are associated with a poor prognosis (Nixon et al, 1992). The effect of intravenous antibiotherapy on peripheral muscle and physical activity remains unclear. Wieboldt et al showed that quadriceps strength at the hospital admission for an exacerbation was lower than before and one month after hospitalisation while Burtin et al showed that individual changes in quadriceps force were correlated with daily time spent activities of at least moderate intensity (Wieboldt et al, 2012; Burtin et al, 2013). The effect of intravenous antibiotherapy itself is poorly known in cystic fibrosis. Moreover, they did not study the impact on muscular strength of hospitalisation versus home treatment. In contrast, in COPD, it is well known that exacerbations are associated with a decline of muscle mass and strength and that repeated exacerbations lead to a more rapid decrease in fat free mass (Spruit et al, 2003; Jones et al, 2015; Joppa et al, 2016).

Hypothesis We think that exacerbations aggravate factors underlying muscle weakness as physical inactivity, systemic inflammation and anabolic status. Moreover, hospitalisation itself might be a reason of inactivity as patients spent all the day inside their room compared to patients who follow their treatment at home and continue their usual life.

Aim The aim of our study is to evaluate the impact of an intravenous antibiotherapy on peripheral muscular strength in patients with cystic fibrosis.

Methods We would compare patients (adults and children) who receive intravenous antibiotherapy for an acute exacerbation, with patients who receive elective intravenous antibiotherapy (decline in lung function without exacerbation). We will also compare hospitalised patients who receive specific exercise training, with patients who follow their antibiotherapy at home without specific exercise training. We will have a stable patients group as control. To evaluate muscular strength we plan to measure quadriceps force at the beginning of the cure and at the end with a functional test, the 1-minute Sit-to-Stand test and a strength (isometric) test, with the Microfet2dynamometer. Those test are not invasive, easy to realise and have already been used in other studies (Ozalevli, 2005). We will quantify the physical activity level of the patients with an accelerometer that they will carry during 72 hours, during the first week of the treatment.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
6 Years 至 99 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with cystic fibrosis following the definition of Rosentein et al (1997), who undergo an intravenous antibiotic cure for an acute exacerbation or electively since we notice a decline of respiratory lung function

排除标准

  • orthopaedic conditions interfering with mobility or the assessment of skeletal muscle force,
  • a pregnancy,
  • a pulmonary graft
  • a negative response for the informed consent.

结局指标

主要结局

Change from peripheral muscular strength at 14 days.

时间窗: At day 0 and day 14 of IV AB

To evaluate the impact of intravenous antibiotherapy on peripheral muscular strength. Is the impact negative or positive?

次要结局

未报告次要终点

研究者

发起方
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hardy

MD, Pneumology assistant

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

研究点 (2)

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