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临床试验/NCT01515163
NCT01515163Unknown不适用

Exercise and Systemic Lupus Erythematosus

University of Sao Paulo2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2010年5月最近更新:
适应症

试验速览

阶段
不适用
入组人数
90
试验地点
2
主要终点
Lipid profile - Plasma levels of total cholesterol (mg/dl), VLDL-chol (mg/dl) HDL-chol (mg/dl), LDL-chol (mg/dl), triglycerides (mg/dl), Apolipoprotein AI and AII (mg/dl) and Apolipoprotein B (mg/dl)

研究概览

简要总结

The investigators hypothesize that a three-month aerobic exercise training program will positively affect the lipid profile, insulin sensitivity , cytokine profile, the cardiovascular parameters and muscle strength in SLE patients.

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
7 Years 至 40 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Age between 7 and 40 years
  • SLEDAI ≤ 4

排除标准

  • Cardiovascular dysfunction
  • Rhythm and conduction disorders
  • Musculoskeletal disturbances
  • Kidney and pulmonary involvements
  • Peripheral neuropathy
  • Use of tobacco
  • Treatment with lipid-lowering or hypoglycemic drugs
  • Fibromyalgia
  • Use of chronotropic or antihypertensive drugs
  • Physically active subjects

结局指标

主要结局

Lipid profile - Plasma levels of total cholesterol (mg/dl), VLDL-chol (mg/dl) HDL-chol (mg/dl), LDL-chol (mg/dl), triglycerides (mg/dl), Apolipoprotein AI and AII (mg/dl) and Apolipoprotein B (mg/dl)

时间窗: 3 months

Insulin sensitivity as measured by the Hyperinsulinemic-Euglycemic Clamp

时间窗: 3 months

Cytokine response - Plasma levels of TNF-α (pg/ml), IL-6 (pg/ml), IFN-type I (pg/ml), IL-10 (pg/ml)and IL-1ra (pg/ml)

时间窗: 3 months

次要结局

  • Cardiovascular parameters(3 months)
  • Muscle Strength(3 months)

研究者

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

Bruno Gualano

PhD, Assistant Professor

University of Sao Paulo

研究点 (2)

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