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临床试验/NCT05926986
NCT05926986招募中不适用

Investigation of Cognitive Functions in Patients With Fibromyalgia Syndrome

Firat University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年7月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
2
主要终点
The Stroop Color and Word Test

研究概览

简要总结

Accumulating research with human adults suggests that a single session of physical exercise ameliorates different aspects of cognitive function immediately after the end of the exercise period, regardless of fitness level. It has now been more clearly demonstrated that the effect of physical exercise on cognitive performance depends both on the intensity and the duration of the exercise. Fibromyalgia (FM) is a complex clinical syndrome characterized by chronic widespread musculoskeletal pain, sleep disturbances, morning stiffness, fatigue, anxiety, and depressive symptoms. The aim of the study is to investigate the effects of exercise on cognitive functions in patients with FM.

详细描述

Fibromyalgia (FM) is a complex clinical syndrome characterized by chronic widespread musculoskeletal pain, sleep disturbances, morning stiffness, fatigue, anxiety, and depressive symptoms. Its etiology is not known, and several aspects of its pathogenesis are being investigated, shedding some light on the possible physiopathologic mechanisms involved in this process.The high prevalence of cognitive dysfunction reported among patients with fibromyalgia (50-80%), and the fact that memory and concentration problems can be very disruptive for patients, makes central to find strategies aiming at improving cognition in this population. Among non-pharmacological treatment options, enhancing physical fitness (mainly through physical exercise) or decreasing body fatness are becoming increasingly popular for improving the fibromyalgia-related symptomatology (including cognitive functioning) and quality of life. Accumulating research with human adults suggests that a single session of physical exercise ameliorates different aspects of cognitive function immediately after the end of the exercise period, regardless of fitness level. It has now been more clearly demonstrated that the effect of physical exercise on cognitive performance depends both on the intensity and the duration of the exercise.The aim of the study is to investigate the effects of exercise on cognitive functions in patients with FM.

Methods: Forty patients diagnosed with FMS according to the 2016 ACR criteria will be included in the study. While patients aged 18-65 whose medical treatment has not changed in the last three months will be included; Patients with pregnancy or malignancy diagnosis, systemic inflammatory rheumatic disease, neurological, orthopedic or congenital problems that prevent physical activity, and regular exercise habits will be excluded from the study. Patients who meet the criteria and agree to participate in the study will be divided into two groups. Routine treatments will be continued without any application to the control group. In the study group, aerobic and pilates exercises combined (30 minutes aerobic exercise to be performed on the treadmill at 60% of the maximum heart rate for 30 minutes, pilates exercises for 30 minutes) in Fırat University Physical Therapy and Rehabilitation Treatment Units, each session lasting approximately one hour, three days a week. ) will be applied. Treatment will continue for eight weeks. The patients participating in the study will be evaluated in their first sessions before starting the treatment and at the end of the treatment (in the eighth week). Stroop Test, verbal fluency test and Beck Depression Inventory will be applied to evaluate cognitive and psychosocial functions.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients who were aged between 18-65 years,
  • Patients who got diagnosed with Fibromyalgia Syndrome

排除标准

  • Patients who had regular exercise habits, malignancy, pregnancy, incorporation,
  • Patients who had changes of medical treatment in last 3 months
  • Patients who diagnosed with Osteoarthritis for lower extremity
  • Patients who had cardiac symptoms according to New York Heart Association
  • Patients who had dysfunction that can prevent physical activity

结局指标

主要结局

The Stroop Color and Word Test

时间窗: 2 minutes

The Stroop Color and Word Test (SCWT) is a neuropsychological test extensively used for both experimental and clinical purposes. It assesses the ability to inhibit cognitive interference, which occurs when the processing of a stimulus feature affects the simultaneous processing of another attribute of the same stimulus

次要结局

  • Verbal Fluency test(2 minutes)
  • Beck Depression Inventory(1 minute)

研究者

发起方
Firat University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Songül Bağlan Yentür

Firat University

Firat University

研究点 (2)

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