此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Exercise Therapy Program in Ankylosing Spondylitis Patients

2016年8月27日 更新者：Andrea Lopes Gallinaro、University of Sao Paulo

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

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.

研究概览

地位

完全的

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (实际的)

55

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 巴西
      • Sao Paulo、巴西、05403-010
        • University of Sao Paulo

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

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

Exclusion Criteria:

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：支持治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
无干预：ankylosing spondylitis control
control group
实验性的：mobility exercise
mobility exercises
其他：mobility exercise
30 minutes, twice a week
实验性的：mobility and elastic resistance exercise
AS patients was submitted to a program mobility exercise plus elastic resistance exercises
其他：mobility and elastic resistance exercise
30 minutes, twice a week each exercises group. (total 1 hour)

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
FUNCTIONAL INDEX
大体时间：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.
Baseline and 16 Weeks
Mobility Index
大体时间：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)
Baseline and 16 weeks
Disease Activity Index
大体时间：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)
Baseline and 16 Weeks
Ankylosing Spondylitis Disease Activity Scale -Disease Activity
大体时间：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
Baseline and 16 Weeks
Global Evaluation Self Reported
大体时间：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.
Baseline and 16 Weeks

次要结果测量

结果测量
措施说明
大体时间
Thoracolumbar Mobility
大体时间：Baseline and 16 Weeks
Thoracolumbar rotation Pavelka. Measured with a tape in centimeters. Higher number means better thoracolumbar rotation
Baseline and 16 Weeks
Pain Scale
大体时间：Baseline and 16 Weeks
Pain was evaluated in a visual analogue scale (VAS) from 0 to 10. higher scores means much pain. Data was expressed by means and standard deviation.
Baseline and 16 Weeks
Stiffness Scale
大体时间：Baseline and 16 Weeks
Stiffness was measured by an VAS varying from 0 to 10. Higher scores means worst stiffness. Data are expressed by mean and SD.
Baseline and 16 Weeks
Short Form-12 (PCS)
大体时间：Baseline and 16 Weeks
Quality of life was analyzed in a physical component score varying from 0 (lowest level of health) to 100 (highest level of health) scale. Data are expressed by mean and SD.
Baseline and 16 Weeks
Short Form-12 (MCS)
大体时间：Baseline and 16 Weeks
Quality of life was analyzed in a mental component score varying from 0 (lowest level of health) to 100 (highest level of health). Data are expressed by mean and SD.
Baseline and 16 Weeks
MASES
大体时间：Baseline and 16 Weeks
Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) score varying from 0 to 13. Where 0 is no painful point reported and 13 is all tender points reported as painful. Data are expressed by means and standard deviation
Baseline and 16 Weeks
Chin-coronoid Distance
大体时间：Baseline and 16 Weeks
lateral rotation of the head (chin-coronoid distance) was measured with a tape in centimeters. Highest score means better lateral rotation mobility. Data are expressed by means and standard deviation
Baseline and 16 Weeks
Tragus-coronoid Distance
大体时间：Baseline and 16 Weeks
lateral flexion of the head (tragus-coronoid distance) was measured with a tape in centimeters. Highest score means better lateral flexion mobility of the head.Data are expressed by means and standard deviation
Baseline and 16 Weeks
Finger Floor Distance
大体时间：Baseline and 16 Weeks
Distance between third finger of the hand and the floor while in lumbar flexion. It was measured with a tape in centimeters. Highest score means better torso flexion mobility. Data are expressed by means and standard deviation
Baseline and 16 Weeks
Chest Expansion
大体时间：Baseline and 16 Weeks
Chest expansion was measured with a tape in centimeters between inspiration and breathing exhaling. Highest score means better chest expansion. Data are expressed by means and standard deviation.
Baseline and 16 Weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of Sao Paulo

调查人员

  • 学习椅：Ana Lucia Pinto, Phd、University of Sao Paulo

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年7月1日

初级完成 (实际的)

2013年6月1日

研究完成 (实际的)

2014年11月1日

研究注册日期

首次提交

2012年9月18日

首先提交符合 QC 标准的

2012年9月20日

首次发布 (估计)

2012年9月21日

研究记录更新

最后更新发布 (估计)

2016年10月20日

上次提交的符合 QC 标准的更新

2016年8月27日

最后验证

2016年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 8206212

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

paper is been written

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅