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临床试验/NCT01690273
NCT01690273
已完成
不适用

Effect of Two Exercise Therapy Program With and Without Elastic Resistance in Ankylosing Spondylitis Patients

University of Sao Paulo1 个研究点 分布在 1 个国家目标入组 55 人2012年7月

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Ankylosing Spondylitis
发起方
University of Sao Paulo
入组人数
55
试验地点
1
主要终点
FUNCTIONAL INDEX
状态
已完成
最后更新
9年前

概览

简要总结

Mobility exercises are used in Ankylosing Spondylitis (AS) patients to preserve and restore axial mobility, but there are no data regarding a specific rehabilitation program that includes flexibility alone and its association with resistance exercises in AS patients with stable disease activity. So, we assessed the effects of two exercise programs in terms of mobility, functional capacity, quality of life and disease activity in AS patients. Methods. Fifty-five sedentary AS patients with a Bath Ankylosing Spondylitis Activity Index (BASDAI) <4 were included.

详细描述

The AS patients were randomly assigned into three groups, to receive a mobility exercise program (M) or mobility plus elastic resistance exercise program (M+R) or no exercise (C). The exercises group sessions were conducted twice per week for 16 weeks. This supervised program comprised 30 minutes of outdoor stretching and mobility exercises for the spine and limbs (M). After the flexibility program, M+R group carry out more 30 minutes of elastic resistance exercises. The mobility, disease activity and functional parameters were evaluated at baseline and after 16 weeks, with the evaluator blinded to the treatment group.

注册库
clinicaltrials.gov
开始日期
2012年7月
结束日期
2014年11月
最后更新
9年前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Principal Investigator
主要研究者

Andrea Lopes Gallinaro

MASTER

University of Sao Paulo

入排标准

入选标准

  • Ankylosing spondylitis patient
  • Basdai index lower than 4
  • Physical inactive
  • Functional class I to III

排除标准

  • Fibromyalgia
  • Cardiovascular disease
  • Pain Visual Analogue Scale ("VAS") over 8

结局指标

主要结局

FUNCTIONAL INDEX

时间窗: Baseline and 16 Weeks

BASFI - Bath ankylosing spondylitis functional index. A scale from 0 to 10 (lower scores means better functional capacity), results are measured by mean and standard deviation.

Mobility Index

时间窗: Baseline and 16 weeks

Bath ankylosing spondylitis motion index. A mean of five mobility measures committed by Ankylosing Spondylitis disease. Higher results means higher limitations in mobility (units of measure from 0 to 10)

Disease Activity Index

时间窗: Baseline and 16 Weeks

BASDAI - Bath ankylosing spondylitis disease activity index. Scale from 0 to 6. Higher scores means worst disease activity. Numbers are expressed in average (SD)

Ankylosing Spondylitis Disease Activity Scale -Disease Activity

时间窗: Baseline and 16 Weeks

Scores vary from 0 to 10, and higher than 4 scores are indicative of disease activity. Data are expressed by means and SD

Global Evaluation Self Reported

时间窗: Baseline and 16 Weeks

Bath Ankylosing Spondylitis Global is a self reported global score varying from 0 to 10. Higher scores means worst health evaluation. Expressed by means and standard deviation.

次要结局

  • Stiffness Scale(Baseline and 16 Weeks)
  • Short Form-12 (PCS)(Baseline and 16 Weeks)
  • Pain Scale(Baseline and 16 Weeks)
  • Chin-coronoid Distance(Baseline and 16 Weeks)
  • Finger Floor Distance(Baseline and 16 Weeks)
  • Thoracolumbar Mobility(Baseline and 16 Weeks)
  • Short Form-12 (MCS)(Baseline and 16 Weeks)
  • MASES(Baseline and 16 Weeks)
  • Tragus-coronoid Distance(Baseline and 16 Weeks)
  • Chest Expansion(Baseline and 16 Weeks)

研究点 (1)

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