Comparing a Ring Fit Adventure exergame program with home exercise for women with fibromyalgia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized study will assign women with fibromyalgia to either a supervised exergame program using Ring Fit Adventure or a home-based exercise program, with sessions twice a week for four weeks. Outcomes including pain, balance, functional mobility, and quality of life will be measured before and after the training period and at a later follow-up. Exercises in the exergame arm are delivered under physiotherapist supervision or remote monitoring, while the control arm follows a traditional home exercise protocol. The trial focuses on engagement, physical function, and psychosocial measures to see if game-based exercise provides added benefit over usual home exercise.

Why it matters

Who can join: the full rules

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

Where it's running

• Halic University
  Istanbul, Turkey (Türkiye) Recruiting

Study contacts

• Principal investigator: Gülhan Fetin, PT — Halic University
• Study coordinator: Ayşenur Çetinkaya, PhD
• Email: aysenurcetinkaya@halic.edu.tr
• Phone: +905077218827

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.