NCT00491309Unknown不适用
Exercise and Respiratory Therapy in Patients With Rheumatoid Arthritis / Collagenosis and Pulmonary Hypertension
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Quality of life (SF-36)
研究概览
简要总结
In Patients with rheumatic disease exercise training is a well established element of therapy. In contrast patients with severe pulmonary hypertension are advised to avoid physical exertion and must not perform exercise training. This study aims to evaluate the effectivity and safety of a low-dose training program in patients with pulmonary hypertension and rheumatic disease.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent
- •Men and women 18 - 80 years
- •Diagnosed rheumatic disease: rheumatoid arthritis, Collagenosis (Systemic Lupus Erythematodes, Systemic Sclerosis, Sjögren-Syndrome, Sharp-Syndrome, Crest-Syndrome, Mixed connective tissue disease)
- •Symptomatic PAH (WHO- functional class II-IV) invasively diagnosed by right heart catheterisation
- •Mean pulmonary artery pressure (mPAP) > 25 mmHg
- •Pulmonary capillary wedge pressure (PCWP) > 15 mmHg
- •Pulmonary vascular resistance (PVR) at baseline >320 dyn.sec/cm5 patients under optimized medical treatment since at least 2 ½ months
排除标准
- •Other forms of PAH.
- •Pregnancy or lactation
- •Change in medication during the last 2 ½ months
- •Patients with signs of right heart decompensation
- •Severe impairment of walking
- •Unclear diagnosis
- •No invasive diagnosis of PH
- •Acute illness, infection, fever
- •Severe lung disease with FEV1 <50% and TLC< 70% below reference
结局指标
主要结局
Quality of life (SF-36)
时间窗: baseline and 15 weeks
Change in the 6-minute walking distance
时间窗: after 3 weeks and after 15 weeks compared to baseline.
次要结局
- Physical capacity in the cardiopulmonary exercise testing (Watt)(baseline, 3 weeks, 15 weeks)
- change of peak oxygen consumption and other parameters of cardiopulmonary exercise testing.(baseline, 3 weeks, 15 weeks)
- hemodynamic parameters: dimension and pump function of the right and the left ventricle.(baseline, 15 weeks)
- change in systolic pulmonary arterial pressure at rest and during exercise(baseline, 3 weeks, 15 weeks)
- change in inflammatory parameters (BKS, CRP, Leucocytes), change in inflammatory cytokines (TNF-α), change in parameters of the vascular endothelium (Endothelin, PDGF, VEGF), and endothelial progenitor cells(baseline and 15 weeks)
- change of NTproBNP-value(baseline, 3 weeks, 15 weeks)
研究者
Prof. Dr. med. Ekkehard Gruenig
Prof. Dr. med. Ekkehard Grünig
Heidelberg University
研究点 (2)
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