Clinical trial NCT05926986: Cognitive Functions in Patients With Fibromyalgia
Official title: Investigation of Cognitive Functions in Patients With Fibromyalgia Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fibromyalgia
Keywords: Fibromyalgia
cognitive functions
exercise
Lead sponsor: Firat University
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: The Stroop Color and Word Test
timeFrame: 2 minutes
Secondary outcomes:
measure: Beck Depression Inventory
timeFrame: 1 minute
measure: Verbal Fluency test
timeFrame: 2 minutes
Other outcomes:
Locations:
city: Elazığ
country: Turkey
facility: Songül Bağlan Yentür
Study officials:
affiliation: Firat University
name: Songül Bağlan Yentür
role: PRINCIPAL_INVESTIGATOR
References: