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NCT Number: NCT07200050

Home-Based Exercise Program for Fibromyalgia

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.

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Key information

Conditions

Fibromyalgia Behavior Motor Activity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kütahya Health Sciences University Hospital

Kütahya, 43290, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

  1. Change in pain intensity (Visual Analog Scale, VAS)

    Time frame: 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

  1. Change in quality of life (Fibromyalgia Impact Questionnaire, FIQ)

    Time frame: 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.

  2. Change in fatigue severity (Visual Analog Scale, VAS)

    Time frame: 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.

  3. Change in depressive symptoms (Beck Depression Inventory, BDI)

    Time frame: 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.

  4. Change in exercise perception (Exercise Benefits and Barriers Scale, EBBS)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Kutahya Health Sciences University

Other

Registry information

Official study title

Effects of Home-based Exercise Program on Pain, Fatigue, Quality of Life, Depression, and Exercise Perception in Fibromyalgia Patients: A Randomized Controlled Trial

Acronym: FIBRO-EX

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 3, 2025
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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