Protocol for a phase II, multicenter, open-label, randomized controlled trial to compare the efficacy of gamification using Nintendo Switch Ring Fit Adventure game versus standard exercise in the treatment of fibromyalgia

Background: Fibromyalgia (FM) is a chronic condition related to dysfunctional central pain processing mechanisms, which affects 3-6% of the world population, leading widespread pain, stiffness, and tenderness muscles, tendons, joints, as well restless sleep, fatigue, depression, anxiety. Exercise most effective way reducing improving global well-being in people with FM, but such patients present an important limitation exercise adherence. Objective: We aim evaluate whether home-based gamification strategy will improve Impact Questionnaire Revised (FIQR) scores female aged 18-60 years old alternative traditional exercise. Methods: The proposed trial multicenter, phase II, open-label, parallel, randomized, superiority trial. Female ranging from 18 60 diagnosis FM be randomized intervention group, designed play Nintendo Switch Ring Fit Adventure game on three weekly sessions, or control receive general educational guidance through videos pamphlets provided by study staff for total 12 weeks. primary outcome mean change FIQR score results. Discussion: development new strategies increase adherence can enhance symptoms low quality physical patients, thereby their life. believe that one used here make activity more playful, accessible, dynamic, motivating increasing function compared those seeking center-based conventional exercises.