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

Официальное название

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

Обзор

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.

Подробное описание

Fibromyalgia (FM) is a chronic disorder characterized by widespread pain, tenderness in specific musculoskeletal regions, fatigue, sleep disturbances, headaches, cognitive dysfunction, muscle weakness, postural instability, altered gait, and an increased risk of falls. Exercise has been reported to be one of the most effective non-pharmacological treatments for FM, and various types of exercise have been proposed. However, the evidence regarding which type of exercise provides optimal benefit remains limited.

Recently, exergame-based exercises - video game-assisted physical activities that combine interactive gaming with exercise - have gained attention as a novel and motivating rehabilitation approach. These programs have been shown to enhance adherence and engagement in different populations, including healthy adults, older individuals, and patients with neurological and musculoskeletal conditions. Nevertheless, research on the use of exergames in individuals with fibromyalgia is scarce, and no studies have been identified that use the Nintendo Switch Ring Fit Adventure game in this population.

This randomized clinical trial aims to compare the effects of an exergame-based exercise program and a home-based exercise program in women diagnosed with fibromyalgia. Participants will be randomly assigned to one of two groups: (1) the exergame group, performing supervised exercises using Ring Fit Adventure twice a week for four weeks, and (2) the home-based exercise group, performing a physiotherapist-prescribed home exercise program twice a week for four weeks.

All participants will be evaluated at baseline and after the 4-week intervention period, and reassessed following a 4-week detraining phase. Data obtained from this study will contribute to understanding the effects of exergame applications on pain, balance, functional mobility, and psychosocial outcomes in women with fibromyalgia. The results are expected to provide evidence supporting the use of exergame-based exercises as an enjoyable and effective approach within rehabilitation programs for individuals with fibromyalgia.

Вмешательства

• Другое Exergaming
  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.
• Другое Home-based exercise
  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).

Первичные конечные точки

• Revised Fibromyalgia Impact Questionnaire [Срок оценки: Assessed at baseline, post-intervention (4 weeks), and at 8-week follow-up]
• Fibromyalgia Severity Scale [Срок оценки: Assessed at baseline, post-intervention (4 weeks), and at 8-week follow-up]

Вторичные конечные точки (7)

• Visual Analog Scale (VAS) [Срок оценки: Assessed at baseline, post-intervention (4 weeks), and at 8-week follow-up]
• 30-Second Sit-to-Stand Test [Срок оценки: Assessed at baseline, post-intervention (4 weeks), and at 8-week follow-up]
• Timed Up and Go Test [Срок оценки: Assessed at baseline, post-intervention (4 weeks), and at 8-week follow-up]
• Single-Leg Stance Test [Срок оценки: Assessed at baseline, post-intervention (4 weeks), and at 8-week follow-up]
• Berg Balance Scale [Срок оценки: Assessed at baseline, post-intervention (4 weeks), and at 8-week follow-up]
• Cognitive Exercise Therapy Approach Scale (BETY-BQ) [Срок оценки: Assessed at baseline, post-intervention (4 weeks), and at 8-week follow-up]
• Short Form-12 (SF-12) [Срок оценки: Assessed at baseline, post-intervention (4 weeks), and at 8-week follow-up]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Halic University — Istanbul

Идентификаторы

NCT: NCT07304167 · Acetinkaya007

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗