Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05926986 |
| Other study ID # |
13-21 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 20, 2023 |
| Est. completion date |
October 20, 2023 |
Study information
| Verified date |
June 2023 |
| Source |
Firat University |
| Contact |
Songül Baglan Yentür |
| Phone |
+90 424 2370000 |
| Email |
sbyentur[@]firat.edu.tr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
