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| ID | Type | Description | Link |
|---|---|---|---|
| FMS-HBEP-2025 | Other Identifier | Ethics Committee of Kütahya Health Sciences University |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home-based Exercise | Other | Participants receive usual care without any additional structured exercise program. Assessments are performed at baseline and after 12 weeks. |
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| Control | No Intervention | Participants receive usual care without any additional structured exercise program. Assessments are performed at baseline and after 12 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
| Change in fatigue severity (Visual Analog Scale, VAS) |
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Inclusion Criteria:
Exclusion Criteria:
Only female participants (biological sex: female) with fibromyalgia are eligible to participate.
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| Name | Affiliation | Role |
|---|---|---|
| Nazlı Karaman, MD | Kütahya Health Sciences University, Department of Physical Medicine and Rehabilitation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kütahya Health Sciences University Hospital | Kütahya | Kütahya | 43290 | Turkey (Türkiye) |
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| ID | Type | URL | Comment |
|---|---|---|---|
| Individual participant data and supporting information will not be shared. | View IPD |
Individual participant data (IPD) will not be shared due to privacy and confidentiality concerns of study participants.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Home-Based Exercise Study Protocol | Mar 31, 2021 | Sep 27, 2025 | Prot_SAP_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Full Study Protocol | Mar 31, 2021 | Sep 27, 2025 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D009043 | Motor Activity |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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Participants were randomly assigned in parallel to either the home-based exercise group or the control group. Both groups were assessed at baseline and after 12 weeks. The study was designed to compare the effects of the exercise program versus usual care on pain, physical function, and quality of life in patients with fibromyalgia
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No parties were masked in this study
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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. |
| 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. | 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). | 12 weeks |
Individual participant data and supporting information will not be shared due to privacy and confidentiality concerns. |
| D009422 |
| Nervous System Diseases |
| D001519 | Behavior |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |