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临床试验/NCT04437524
NCT04437524已完成不适用

Comparison of the Effects of Balance-proprioception and Aerobic Exercises on Functional Status, Pain and Strength Parameters in Patients With Fibromyalgia Syndrome (FMS).

Istanbul University1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2020年8月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
51
试验地点
1
主要终点
Fibromyalgia Impact Questionnaire (FIQ)

研究概览

简要总结

In this study, it was aimed to examine the effects of aerobic exercise and balance-proprioception exercises on pain, functionality and strength parameters of fibromyalgia patients and to compare the two exercise types.

详细描述

In the study planned to evaluate the effect of aerobic and balance-proprioception exercises on the symptoms of the disease and the superiority of the two exercise models in patients with fibromyalgia syndrom (FMS), 62 women who meet the inclusion criteria will be randomly divided into two groups. Aerobic exercise group (n = 26) and balance-proprioception exercise group (n = 26) will be applied for 3 weeks a week, 6 days a week under the supervision of a physiotherapist in the exercise laboratory of the Istanbul Medical Faculty Sports Medicine Department. Pain (VAS), functional status (FİQ) and knee extension muscle strength (Cybex isokinetic dynamometer) will be evaluated before and after the program. Cognitive status will be evaluated with standardized Mini Mental Test only before the program.

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
None

入排标准

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

入选标准

  • Being between the ages of 18 and 60,
  • Symptoms lasting longer than 3 months,
  • According to the 2013 ACR criteria, the Pain Settlement Score (PLI) is ≥17,
  • According to the 2013 ACR criteria, the Symptomatic Impact Scoring (SIQR) is ≥21,
  • Acceptance of treatment that will continue 3 days a week for 6 weeks,
  • The possibility of any change in medical treatment due to FMS during the study is not foreseen.

排除标准

  • Known central or peripheral nervous system disease, progressive neurological damage,
  • Any serious cardiovascular pathology,
  • Sense, loss of sense of position, unhealed fracture or a surgical wound,
  • Presence of uncontrolled hypertension,
  • Failure to understand or perform simple commands.

结局指标

主要结局

Fibromyalgia Impact Questionnaire (FIQ)

时间窗: 6 weeks

In order to evaluate the functional status in patients with FMS, FIQ Burchardt et al. It is a specific scale developed by. FIQ consists of 10 items. Calculation is made so that the upper limit of each item is 10 points. The maximum score that can be reached is 100. A high total score indicates that the person is more affected by the disease.

Pain (Visual Analogue Scale)

时间窗: 6 weeks

Visual Analaog Scale is used to measure the severity of pain in patients. The patient is told that there is no "0" pain on the 10 cm ruler drawn on paper, "10" is the most experienced pain, and the patient is asked to mark on the ruler according to the severity of the pain he/she feels. The distance of the marked point from zero is recorded as the Visual Analogue Scale score in cm.

Muscle Strength Evaluation

时间窗: 6 weeks

The CSMI Humac Norm 2015 isokinetic dynamometer will be used to evaluate muscle strength.

次要结局

未报告次要终点

研究者

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

Hadi Yavuz

Principal Investigator

Istanbul University

研究点 (1)

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