Investigation of the Effectiveness of a Exergame Program in Women With Fibromyalgia

A vizsgálat adatai

Ki végzi

Halic University

Azonosító

NCT07304167

A regiszteradat frissítve

2026. január 9.

Eredeti leírás

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).A teljes eredeti leírásKevesebb

Investigation of the Effectiveness of a Video-Based Exercise (Exergame) Program in Women With Fibromyalgia: A Randomized Controlled Trial

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.

Bevonási feltételek: 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.

Kizáró feltételek: Surgery within the last four months; 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; 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; 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; Severe psychiatric illness (such as uncontrolled depression and anxiety, personality disorders, dementia, or cognitive impairments related to substance abuse); Pregnancy or breastfeeding; Peripheral neuropathy; Pneumothorax; Neoplasia; Body mass index (BMI) greater than 29.9.

ClinicalTrials.gov NCT07304167