Investigation of the Effectiveness of a Exergame Program in Women With Fibromyalgia
Investigation of the Effectiveness of a Video-Based Exercise (Exergame) Program in Women With Fibromyalgia: A Randomized Controlled Trial
Halic University
20 participants
Dec 15, 2025
INTERVENTIONAL
Conditions
Summary
The goal of this clinical trial is to compare the effects of an exergame-based exercise program and a home-based exercise program in women aged 30-70 years diagnosed with fibromyalgia (FM). The main questions it aims to answer are: Does an exergame-based program using the Nintendo Switch game Ring Fit Adventure improve pain, balance, and functional mobility in women with fibromyalgia? Is the exergame program more effective than a traditional home-based exercise program in improving physical and psychosocial outcomes? Researchers will compare the exergame group and the home-based exercise group to determine whether game-based exercises provide superior benefits in pain reduction, balance, and quality of life. Participants will: Be randomly assigned to either the exergame or the home-based exercise group. Exercise twice a week for four weeks under the supervision of a physiotherapist or via remote monitoring. Undergo evaluations before and after the 4-week training period, and again after a 4-week detraining period. Assessments will include: Pain intensity (Visual Analog Scale) Disease severity (Revised Fibromyalgia Impact Questionnaire, Widespread Pain Index, Symptom Severity Scale, Fibromyalgia Severity Scale) Lower extremity strength (Sit-to-Stand Test) Functional mobility (Timed Up and Go Test) Balance (Single-Leg Stance Test, Berg Balance Scale) Psychosocial status (Cognitive Exercise Therapy Approach Questionnaire - BETY-BQ) Quality of life (Short Form-12) Study findings are expected to provide evidence for the effectiveness of exergame applications as an enjoyable rehabilitation approach for individuals with fibromyalgia.
Eligibility
Inclusion Criteria4
- Women aged between 30 and 70 years, which is an age range in which fibromyalgia (FM) is more prevalent;
- Having a diagnosis of fibromyalgia;
- Being willing to participate in the study and signing the informed consent form;
- Meeting the 2016 American College of Rheumatology (ACR) diagnostic criteria, defined as a Widespread Pain Index (WPI) ≥ 7 and a Symptom Severity Scale (SSS) score ≥ 5, or WPI = 4-6 and SSS ≥ 9.
Exclusion Criteria16
- Pregnancy or breastfeeding
- Any known advanced pathology related to the locomotor system that contraindicates physical activity (such as arthritis, osteoarthritis, or uric acid disorders)
- Epilepsy
- History of severe headache
- Neurological disorder
- Peripheral neuropathy
- Known severe cardiovascular disease (such as endocranial hypertension, uncontrolled arterial hypertension, heart failure, or presence of a pacemaker)
- Orthopedic disorders of the upper or lower extremities that prevent participation in physical activity
- Rheumatologic disease other than fibromyalgia
- Pneumothorax
- Neoplasia
- Surgery within the last four months
- Severe psychiatric illness (such as uncontrolled depression and anxiety, personality disorders, dementia, or cognitive impairments related to substance abuse)
- Diagnosis of alcohol dependence or use of psychoactive drugs or narcotics
- Participation in any physical activity program within two months prior to the start of the study
- Body mass index (BMI) greater than 29.9
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Interventions
Participants in the exergame group will perform exercises using the Nintendo Switch game Ring Fit Adventure under the supervision of a physiotherapist, twice a week for four weeks. The exergame program was designed by a specialist physiotherapist.
Participants in the home-based exercise group will perform exercises prescribed by a specialist physiotherapist as a home program, twice a week for four weeks. The exercises will be taught to participants in face-to-face sessions. Once a week, participants in the home-based exercise group will meet via Zoom to monitor exercise accuracy and progression. The home-based exercise program was adapted from the study conducted by Gentile et al. (2024).
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07304167