Cognitive Functions in Patients With Fibromyalgia
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| ClinicalTrials.gov Identifier: NCT05926986 |
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Recruitment Status :
Recruiting
First Posted : July 3, 2023
Last Update Posted : July 3, 2023
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Fibromyalgia | Other: Exercise Other: control | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 30 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Investigation of Cognitive Functions in Patients With Fibromyalgia Syndrome |
| Estimated Study Start Date : | July 20, 2023 |
| Estimated Primary Completion Date : | September 20, 2023 |
| Estimated Study Completion Date : | October 20, 2023 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Study group
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.
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Other: Exercise
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. |
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Experimental: Control group
No additional treatment will be practiced to the control group.
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Other: control
No additional treatment will be practiced to the control group. |
- The Stroop Color and Word Test [ Time Frame: 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
- Beck Depression Inventory [ Time Frame: 1 minute ]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 [ Time Frame: 2 minutes ]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.
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Gender Based Eligibility: | Yes |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05926986
| Contact: Songül Bağlan Yentür | +90 424 2370000 | sbyentur@firat.edu.tr | |
| Contact: Şahin Elbastı | +90 424 2370000 | msahin23@hotmail.com |
| Turkey | |
| Songül Bağlan Yentür | Recruiting |
| Elazığ, Turkey, 23100 | |
| Contact: Songül Bağlan Yentür | |
| Principal Investigator: | Songül Bağlan Yentür | Firat University |
| Responsible Party: | Songül Bağlan Yentür, Firat University |
| ClinicalTrials.gov Identifier: | NCT05926986 |
| Other Study ID Numbers: |
13-21 |
| First Posted: | July 3, 2023 Key Record Dates |
| Last Update Posted: | July 3, 2023 |
| Last Verified: | June 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Fibromyalgia cognitive functions exercise |
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Fibromyalgia Myofascial Pain Syndromes Muscular Diseases Musculoskeletal Diseases |
Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases |