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临床试验/NCT03750929
NCT03750929已完成不适用

Aerobic Capacity and Strength Exercise in Takayasu's Arteritis: Impact on Clinical, Laboratory and Vascular Parameters

University of Sao Paulo2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2018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
入组人数
12
试验地点
2
主要终点
Security of acute session of combined physical exercises

研究概览

简要总结

Takayasu's arteritis is a primary systemic vasculitis that affects large vessels and their main branches. The objectives of the present study were to assess: a) the aerobic capacity (CA); b) security of the acute strength exercise session; c) correlation between CA, as well as strength exercise session, with demographic, clinical, therapeutic, comorbid parameters, and presence and degree of vascular damage; d) serum levels of the cytokines

详细描述

Takayasu's arteritis (TA) is a primary systemic vasculitis that affects large vessels and their main branches. It mainly affects young women. Blood vessel inflammation may result in stenosis, occlusions, ectasias and/or aneurysms and, consequently, difference of blood pressure between limbs and vascular claudication. Aerobic capacity (CA) is the measure of oxygen uptake, transport and use by the body, characterizing the individual's ability to perform activity. It is also a tool that can predict cardiovascular diseases. Our group has been a pioneer in demonstrating that CA is decreased in the small sample of the young women with TA. In addition, the safety and efficacy of aerobic exercises in this sample of patients were shown, as well as the influence of these sessions on the pro-inflammatory and angiogenic serum levels of the cytokines. However, due to the small samples, it was not possible to correlate CA with clinical and laboratory parameters and also with the presence of vascular damage. Moreover, to date, no studies have evaluated securityof an acute strength exercise session in TA.Therefore, thes objectives of the present study were to evaluate: a) the CA; b) security of the acute strength exercise session; c) correlation between CA, as well as strength exercise session, with demographic, clinical, therapeutic, comorbid parameters, and presence and degree of vascular damage; d) serum levels of the cytokine.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Classification criteria of Takayasu's arteritis
  • Sedentarism

排除标准

  • Peripherical arterial diseases
  • Non-controlled cardiovascular diseases
  • Neurological diseases
  • Patients with walking problem

结局指标

主要结局

Security of acute session of combined physical exercises

时间窗: One week before the exercises

Acute aerobic with strength muscle test exercise

次要结局

  • Strength muscle tests 1(Twice (within 1 week before and until 30 minutes after acute combined physical exercises))
  • Laboratory analysis (Erythrocyte rate sedimentation)(Twice (within 1 week before and until 30 minutes after acute combined physical exercises))
  • Healthy Assessment Questionnaire (HAQ)(Twice (within 1 week before and until 30 minutes after acute combined physical exercises))
  • Laboratory analysis (Serum levels of the protein C-reactive)(Twice (within 1 week before and until 30 minutes after acute combined physical exercises))
  • Indian Takayasu's Arteritis Activity Score (ITAS 2010)(Twice (within 1 week before and until 30 minutes after acute combined physical exercises))
  • Cardiopulmonary test(Once (within 1 week before acute combined physical exercises))
  • Strength muscle tests 2(Twice (within 1 week before and until 30 minutes after acute combined physical exercises))
  • Strength muscle tests 3(Twice (within 1 week before and until 30 minutes after acute combined physical exercises))
  • Strength muscle tests 4(Twice (within 1 week before and until 30 minutes after acute combined physical exercises))

研究者

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

Samuel Katsuyuki Shinjo, PhD

Professor, PhD

University of Sao Paulo

研究点 (2)

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