NCT07304167 Investigation of the Effectiveness of a Exergame Program in Women With Fibromyalgia
| NCT ID | NCT07304167 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Halic University |
| Condition | Fibromyalgia |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-12-15 |
| Primary Completion | 2026-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-12-15 with a primary completion date of 2026-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Gülhan Fetin, PT
PRINCIPAL INVESTIGATOR
Halic University
Frequently Asked Questions
Who can join the NCT07304167 clinical trial?
This trial is open to female participants only, aged 30 Years or older, up to 70 Years, studying Fibromyalgia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07304167 currently recruiting?
Yes, NCT07304167 is actively recruiting participants. Contact the research team at aysenurcetinkaya@halic.edu.tr for enrollment information.
Where is the NCT07304167 trial being conducted?
This trial is being conducted at Istanbul, Turkey (Türkiye).
Who is sponsoring the NCT07304167 clinical trial?
NCT07304167 is sponsored by Halic University. The principal investigator is Gülhan Fetin, PT at Halic University. The trial plans to enroll 20 participants.
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