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临床试验/NCT03400527
NCT03400527Unknown不适用

The Effects of Self Directed Exercise on People With Fibromyalgia

Shenandoah University2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2018年3月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
10
试验地点
2
主要终点
Change in Fibromyalgia Impact Questionnaire

研究概览

简要总结

The purpose of this study is to determine the effects of self directed exercise on pain and function reported in patients with Fibromyalgia both in the short term and long term. Previous studies have shown that patients with fibromyalgia respond better to a single session of self directed exercise compared to prescriptive exercise. To the investigator's knowledge, no studies have examined the impact on pain and function after multiple sessions of self directed exercise in this patient population.

This study hoes to be a case series exploring the effects of self directed exercise on participants with fibromyalgia. Participants will be encouraged to exercise 8-12 times in a 4 week time frame at a self selected pace and intensity on a stationary bicycle. Outcome measures such as the Fibromyalgia Impact Questionnaire, SF-36 and Numeric Pain Rating Scale will be used prior to study participation as well as 4 and 8 weeks following the start of participation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • over the age of 18
  • a medical diagnosis of Fibromyalgia
  • sedentary level of activity prior to entry. Sedentary level of activity is defined as: no participation in regular physical activity more strenuous than slow paced walking for a maximum of 2 times per week for the 4 months prior to study entry.
  • signed release from their physician stating that they are able to participate in the study.

排除标准

  • presence of an acute or chronic medical condition such as cancer
  • infection, cardiovascular or respiratory disease (that would limit their exercise participation), metabolic or musculoskeletal or neurologic condition (systemic lupus or rheumatoid arthritis, or other pain disorders)
  • already participating or plan on participating in a regular aerobic exercise program 6 months prior to the study
  • ongoing or planned Physical Therapy treatment
  • drug dependency

研究组 & 干预措施

Exercise

Experimental

Participant will be pedaling a stationary exercise bicycle

干预措施: Exercise (Other)

结局指标

主要结局

Change in Fibromyalgia Impact Questionnaire

时间窗: 0, 4 and 8 weeks

An instrument developed to assess the current health status of women with the fibromyalgia syndrome in clinical and research settings1. Assesses current health and functional status in people with Fibromyalgia

次要结局

  • Change in Short Form (SF) - 36(0, 4 and 8 weeks)
  • Change in Numeric Pain Rating Scale(0, 4 and 8 weeks)

研究者

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

AJ Lievre

Assistant Professor

Shenandoah University

研究点 (2)

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