Home-Based Exercise Program for 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).

• Home-based Exercise Program (Other): Participants follow a 12-week home-based exercise program including aerobic, strengthening, and flexibility exercises. Assessments are done at baseline and after 12 weeks.

Primary outcomes

• Change in pain intensity (Visual Analog Scale, VAS) [12 weeks]: 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.

Secondary outcomes

• Change in quality of life (Fibromyalgia Impact Questionnaire, FIQ) [12 weeks]: 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.
• Change in fatigue severity (Visual Analog Scale, VAS) [12 weeks]: 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.
• Change in depressive symptoms (Beck Depression Inventory, BDI) [12 weeks]: 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.
• Change in exercise perception (Exercise Benefits and Barriers Scale, EBBS) [12 weeks]: 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).

Sex: Female, ages: 18 Years to 65 Years

Inclusion Criteria:

* Age between 18 and 65 years
* Voluntary participation in the study
* Diagnosis of fibromyalgia according to the 2016 ACR criteria
* Female gender
* Pain severity score of ≥4/10 on the Visual Analog Scale (VAS)

Exclusion Criteria:

* Pregnancy
* History of malignancy
* Pre-existing neurological, endocrine, infectious, or inflammatory rheumatic diseases
* Severe psychiatric disorders
* Advanced cardiac, respiratory, or musculoskeletal conditions that would prevent exercise
* Participation in an exercise or physical therapy program within the last 6 months
* Any changes to current medical treatment during the study period

• Study Protocol and Statistical Analysis Plan: Home-Based Exercise Study Protocol (PDF, 2021-03-31)
• Study Protocol and Statistical Analysis Plan: Full Study Protocol (PDF, 2021-03-31)

• Nazlı Karaman, MD, Principal investigator, Kütahya Health Sciences University, Department of Physical Medicine and Rehabilitation