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Cognitive Functions in Patients With Fibromyalgia

Primary Purpose

Fibromyalgia

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercise
control
Sponsored by
Firat University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia, cognitive functions, exercise

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Songül Bağlan YentürRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Study group

Control group

Arm Description

Aerobic exercise will be performed to all participants for a single session. Maximum heart rate was calculated for each subject (220 - age) and a heart rate monitor (Polar FT 100, China) will be used to follow subjects' heart rate during aerobic exercise. Additionally, pilates exercises will be performed three days in a week. Treatment will continue an hour in per session for 8 weeks.

No additional treatment will be practiced to the control group.

Outcomes

Primary Outcome Measures

The Stroop Color and Word Test
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

Secondary Outcome Measures

Beck Depression Inventory
Turkish version of Beck Depression Inventory (BDI) will be used to determine the depression levels of subjects. It consists of 21 items regarding pessimism, guilt, sleep, appetite and fatigue and each item is scored between 0 and 3. Higher scores shows the severity of depression.Score > 18 of BDI was considered as a cut-off value for depression.
Verbal Fluency test
The Verbal Fluency Test consists of lexical and semantic fluency tests. Sustained attention and vocabulary skill scanning ability are measured. The patient is asked to say as many words containing given letters (K, A, S) as possible in a minute, for word fluency. In category fluency, the patient is asked to say as many animal names as he or she can. The total number of words found is included to the scores.

Full Information

First Posted
June 23, 2023
Last Updated
June 23, 2023
Sponsor
Firat University
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1. Study Identification

Unique Protocol Identification Number
NCT05926986
Brief Title
Cognitive Functions in Patients With Fibromyalgia
Official Title
Investigation of Cognitive Functions in Patients With Fibromyalgia Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 20, 2023 (Anticipated)
Primary Completion Date
September 20, 2023 (Anticipated)
Study Completion Date
October 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Firat University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Fibromyalgia, cognitive functions, exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Experimental
Arm Description
Aerobic exercise will be performed to all participants for a single session. Maximum heart rate was calculated for each subject (220 - age) and a heart rate monitor (Polar FT 100, China) will be used to follow subjects' heart rate during aerobic exercise. Additionally, pilates exercises will be performed three days in a week. Treatment will continue an hour in per session for 8 weeks.
Arm Title
Control group
Arm Type
Experimental
Arm Description
No additional treatment will be practiced to the control group.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Aerobic exercise will be performed to all participants for a single session. Maximum heart rate was calculated for each subject (220 - age) and a heart rate monitor (Polar FT 100, China) will be used to follow subjects' heart rate during aerobic exercise. Additionally, pilates exercises will be performed three days in a week. Treatment will continue an hour in per session for 8 weeks.
Intervention Type
Other
Intervention Name(s)
control
Intervention Description
No additional treatment will be practiced to the control group.
Primary Outcome Measure Information:
Title
The Stroop Color and Word Test
Description
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
Time Frame
2 minutes
Secondary Outcome Measure Information:
Title
Beck Depression Inventory
Description
Turkish version of Beck Depression Inventory (BDI) will be used to determine the depression levels of subjects. It consists of 21 items regarding pessimism, guilt, sleep, appetite and fatigue and each item is scored between 0 and 3. Higher scores shows the severity of depression.Score > 18 of BDI was considered as a cut-off value for depression.
Time Frame
1 minute
Title
Verbal Fluency test
Description
The Verbal Fluency Test consists of lexical and semantic fluency tests. Sustained attention and vocabulary skill scanning ability are measured. The patient is asked to say as many words containing given letters (K, A, S) as possible in a minute, for word fluency. In category fluency, the patient is asked to say as many animal names as he or she can. The total number of words found is included to the scores.
Time Frame
2 minutes

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Songül Bağlan Yentür
Phone
+90 424 2370000
Email
sbyentur@firat.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Şahin Elbastı
Phone
+90 424 2370000
Email
msahin23@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Songül Bağlan Yentür
Organizational Affiliation
Firat University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Songül Bağlan Yentür
City
Elazığ
ZIP/Postal Code
23100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Songül Bağlan Yentür

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://pubmed.ncbi.nlm.nih.gov/21725900/
Description
Exercise therapy for fibromyalgia
URL
http://pubmed.ncbi.nlm.nih.gov/19420402/
Description
Exercise, fibromyalgia, and fibrofog: a pilot study

Learn more about this trial

Cognitive Functions in Patients With Fibromyalgia

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