跳至主要内容
临床试验/NCT01384123
NCT01384123Unknown不适用

Rehabilitation in Pulmonary Sarcoidosis: a Prospective Study

Meir Medical Center1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2011年8月最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
Improvment in 6 minute walking distance and VO2/KG max following pulmonary rehabilitation.

研究概览

简要总结

Sarcoidosis is a heterogeneous multisystem disorder of unknown etiology which often presents with bilateral hilar lymphadenopathy, pulmonary infiltration and ocular and skin lesions. In addition to possible changes in forced vital capacity (FVC) and carbon monoxide transfer factor (TLCO), a higher prevalence of clinical depression, reduced health status and exercise intolerance have been observed in patients with sarcoidosis.

Reduced health status has been related to decreased pulmonary function, depressive symptoms, and to respiratory muscle weakness. Exercise capacity is believed to be limited by dyspnea, an insufficient heart rate response, decreased arterial oxygen tension during exercise, excessive and inefficient ventilation and by respiratory muscle weakness.

In the past, exercise capacity was shown to be limited by skeletal muscle weakness in patients with chronic pulmonary or cardiac disease. 67% of the sarcoidosis patients studied by Miller et al terminated their peak exercise test due to "leg complaints". Skeletal muscle weakness is therefore still assumed to be present in patients with sarcoidosis.

Treatment with oral corticosteroids, clinical symptoms of depression, myositis, self-reported complaints of fatigue and high circulating levels of tumour necrosis factor-α (TNF-α) are all present in patients with sarcoidosis and can all affect skeletal muscle force and exercise capacity. Additionally, low levels of circulating insulin-like growth factor I (IGF-I), which can be induced by high levels of TNF-α, and high circulating levels of interleukin (IL)-6 and IL-8 (CXCL8) have been associated with skeletal muscle weakness. These interleukins are part of the current concept of the immunopathogenesis of sarcoidosis16 and may be raised in patients with stable sarcoidosis.

Recent studies have shown that pulmonary rehabilitation program can lead to improve in the health status and anxiety among patients with chronic obstructive lung disease .However, no study has evaluated the role of pulmonary rehabilitation among patients with sarcoidosis.

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
18 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Stable pulmonary sarcoidosis with no change in medication during the last 3 months.

排除标准

  • Any significant other pulmonary and\or co-morbidity that can affect exercise tolerance.
  • Chronic steroid treatment more than 5 mg/day.
  • Previous lung surgery.
  • Advanced heart failure (NYHA III-IV )
  • Malignancy during the last 3 years

结局指标

主要结局

Improvment in 6 minute walking distance and VO2/KG max following pulmonary rehabilitation.

时间窗: 16 weeks

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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