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临床试验/NCT03494062
NCT03494062Unknown不适用

Exercise in Juvenile Takayasu Disease: a Randomized Controlled Trial

University of Sao Paulo2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2018年3月5日最近更新:
适应症

试验速览

阶段
不适用
入组人数
21
试验地点
2
主要终点
Arterial inflammation

研究概览

简要总结

Juvenile Takayasu disease is characterized by chronic inflammation that leads to vascular disease. Exercise may render anti-inflammatory effects and protect against cardiovascular events. This trial aims to investigate the therapeutic role of exercise in juvenile Takayasu disease.

详细描述

Takayasu's Arteritis (TA) is a chronic inflammatory disease that affects large and medium-sized arteries. The number of cases describe in children and adolescents has growing, and the hypertension is one of the symptoms most common, followed by other manifestations that affects cardiovascular systems. All clinical manifestations may aggravate by physical inactivity and can creating a vicious cycle of inflammation, whereas the risks of morbidity and mortality increase significantly in the pediatric population, impairing function and physical capacity, quality of life and evolution to adult life. Thereby, physical exercise it is show to be an efficient strategy to reduce all these risk factors, however, no one study, until now, was conducted to available the effects of exercise in children with TA. Objective: Investigated the effects of 12-week home-based exercise program, where the patients receive a guideline from a physical education professional, teaching how to do the exercise at home. The beneficial effects of the programs expect is to be associated with improved cardiovascular risk factors, function and physical capacity, and body composition. Methods: This is a prospective, longitudinal and randomized clinical trial. All patients will be recruited at the Clinical Hospital of the University of Sao Paulo Medical School (HC-FMUSP), in the Laboratory of Evaluation and Conditioning in Rheumatology, Pediatric Rheumatology outpatient clinics of the Department of Pediatrics, Federal University of São Paulo and The Children's Institute of the University of São Paulo and the Vasculitis Unit of the HC-FMUSP Rheumatology Service. In order to evaluate the therapeutic effects of exercise program act on TA, the following pre and post intervention evaluations will be performed: physical activity level; Global clinical evaluation; Anthropometry and body composition; Hematological and inflammatory blood parameters; Cardiovascular risk factors; Aerobic capacity; Functional capacity and fatigue; quality of life; and 18 FDG PET with magnetic resonance angiography.

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
Single (Care Provider)

入排标准

年龄范围
7 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosis of juvenile Takayasu disease

排除标准

  • cardiac and renal insufficiency
  • physical limitation hampering exercise training
  • non-controlled metabolic disorders
  • associated chronic diseases (last 6 months)

结局指标

主要结局

Arterial inflammation

时间窗: 12 weeks

as assessed by positron emission tomography - magnetic ressonance (PET-MR)

Blood inflammatory markers

时间窗: 12 weeks

interleukin-6, interleukin 10, interleukin-12

velocity sedimentation rate

时间窗: 12 weeks

velocity sedimentation rate

Blood inflammatory marker

时间窗: 12 weeks

C-reactive protein

次要结局

  • Timed stands test(12 weeks)
  • Isometric strength(12 weeks)
  • Maximal strength test(12 weeks)
  • timed-up-and-go test(12 weeks)
  • Maximal aerobic capacity(12 weeks)
  • Body composition(12 weeks)
  • Fatigue severity scale FSS(12 weeks)
  • Childhood Health Assessment Questionaire (CHAQ)(12 weeks)
  • Physical activity levels(12 weeks)
  • Quality of life(12 weeks)
  • Hypotension after acute exercise session(12 weeks)
  • The Paediatric Vasculitis Activity Score (PVAS)(12 weeks)
  • Indian Takayasu's Arteritis Activity Score 2010 (ITAS2010(12 weeks)
  • National Institute of Health (NIH)(12 weeks)

研究者

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

Bruno Gualano

Professor

University of Sao Paulo

研究点 (2)

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