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临床试验/NCT01351311
NCT01351311已完成不适用

Assessment of Effectiveness of Resistance Training Exercise Using the Swiss Ball in Patients With Ankylosing Spondylitis

Federal University of São Paulo2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2011年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Bath Ankylosing Spondylitis Functional Index (BASFI)

研究概览

简要总结

The aim of the present study is to assess the effectiveness of resistance training with swiss ball in the treatment of patients with ankylosing spondylitis.

详细描述

A randomized, controlled, single-blind, prospective trial being conducted involving 54 patients with ankylosing spondylitis, selected from outpatient clinics - UNIFESP. They will be randomized in intervention group (n = 27) conduct training for muscle strengthening with the aid of the Swiss ball and in the control group (n = 27) did not undergo any intervention. Eight exercises will be conducted with intent to engage all muscle groups.

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 (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with established diagnosis of AS steinbrocker functional class I-II
  • Basic medication stable for at least three months
  • Agreed to participate and signed term of informed consent

排除标准

  • Uncontrolled hypertension
  • Coronary artery disease
  • History of revascularization
  • History of syncope or arrhythmias induced by exercise
  • Decompensated diabetes mellitus
  • Severe psychiatric illness
  • Fibromyalgia
  • Another medical condition more disabling than AS
  • History of exercise regular (at least 30 minutes 2 times per week)

结局指标

主要结局

Bath Ankylosing Spondylitis Functional Index (BASFI)

时间窗: 16 weeks

Functional capacity assessed by BASFI

次要结局

  • 6-MINUTE WALK TEST(16 weeks)
  • TIME UP AND GO TEST(16 weeks)
  • LIKERT SCALE(16 weeks)
  • 1 REPETITION MAXIMUM TEST(16 weeks)
  • Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)(16 weeks)
  • Bath Ankylosing Spondylitis Metrology Index (BASMI)(16 weeks)
  • erythrocyte sedimentation rate (ESR)(16 weeks)
  • Short form-36 (SF-36)(16 weeks)
  • QUANTITY OF ANALGESICS AND ANTI-INFLAMATORY USED(16 weeks)
  • Health Assessment Questionnaire (HAQ) Health Assessment Questionnaire(16 weeks)

研究者

发起方
Federal University of São Paulo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marcelo Cardoso de Souza

MsC

Federal University of São Paulo

研究点 (2)

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