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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 人开始时间: 2012年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
55
试验地点
1
主要终点
FUNCTIONAL INDEX

研究概览

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

性别
All
接受健康志愿者
否

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

研究组 & 干预措施

ankylosing spondylitis control

No Intervention

control group

mobility exercise

Experimental

mobility exercises

干预措施: mobility exercise (Other)

mobility and elastic resistance exercise

Experimental

AS patients was submitted to a program mobility exercise plus elastic resistance exercises

干预措施: mobility and elastic resistance exercise (Other)

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)

研究者

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

Andrea Lopes Gallinaro

MASTER

University of Sao Paulo

研究点 (1)

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