This study aims to evaluate the effects of a home-based exercise program on patients with fibromyalgia. Participants will be randomly assigned to either an exercise group or a control group. The study will last 12 weeks, and the outcomes will measure improvements in pain, physical function, and quality of life. Participation involves attending scheduled assessments at the Department of Physical Medicine and Rehabilitation, University Hospital. This study helps understand whether a structured home exercise program can benefit individuals with fibromyalgia.
Fibromyalgia is a chronic pain syndrome affecting multiple systems, leading to reduced physical function and quality of life. This prospective, randomized, controlled study evaluates the effects of a 12-week home-based exercise program adapted from the Turkish Fibromyalgia Patient Handbook. A total of 60 patients meeting American College of Rheumatology (ACR) 2016 fibromyalgia criteria will be randomly assigned to the exercise or control group. The exercise group will follow a structured home exercise plan, including aerobic, strengthening, and flexibility exercises, while the control group will continue usual care. Outcomes will include pain intensity, physical function (measured by validated scales), and quality of life assessments, evaluated at baseline and after 12 weeks. The study is conducted at the Department of Physical Medicine and Rehabilitation, University Hospital, under ethical approval from the Kutahya Health Sciences University Ethics Committee (Approval No: 2021-02/10, 31 May 2021).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Participants follow a 12-week home-based exercise program including aerobic, strengthening, and flexibility exercises. Assessments are done at baseline and after 12 weeks.
Kütahya Health Sciences University Hospital
Kütahya, Kütahya, Turkey (Türkiye)
Change in pain intensity (Visual Analog Scale, VAS)
Change in pain intensity from baseline to week 12 measured by the Visual Analog Scale (VAS).The VAS ranges from 0 to 10, where 0 indicates no pain and 10 indicates unbearable pain. Higher scores indicate worse pain.
Time frame: 12 weeks
Change in quality of life (Fibromyalgia Impact Questionnaire, FIQ)
Change in quality of life assessed by the Fibromyalgia Impact Questionnaire (FIQ) from baseline to week 12.FIQ scores range from 0 to 100, with higher scores indicating greater disease impact and worse quality of life.
Time frame: 12 weeks
Change in fatigue severity (Visual Analog Scale, VAS)
Change in fatigue severity from baseline to week 12 measured by the Visual Analog Scale (VAS).The VAS ranges from 0 to 10, where 0 indicates no fatigue and 10 indicates intolerable fatigue. Higher scores indicate worse fatigue.
Time frame: 12 weeks
Change in depressive symptoms (Beck Depression Inventory, BDI)
Change in depressive symptoms from baseline to week 12 assessed by the Beck Depression Inventory (BDI).BDI scores range from 0 to 63, with higher scores indicating more severe depressive symptoms.
Time frame: 12 weeks
Change in exercise perception (Exercise Benefits and Barriers Scale, EBBS)
Change in exercise perception from baseline to week 12 assessed by the Exercise Benefits and Barriers Scale (EBBS). EBBS has two subscales: Benefits (higher scores = more positive perception) and Barriers (higher scores = greater perceived barriers to exercise).
Time frame: 12 weeks
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