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

Sponsor
Halic University
Study ID
NCT07304167
Status
Recruiting

Conditions

  • Exergaming
  • Fibromyalgia

Eligibility Criteria

Sex
FEMALE
Age
30 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Exergaming — OTHER
    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.
  • Home-based exercise — OTHER
    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).

Study Details

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.

Key Dates

First listed
Dec 26, 2025
Start date
Dec 15, 2025
Status verified
Jan 2026
Primary completion
Feb 28, 2026
Completion
Mar 5, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Exergame group
    Participants in this group will perform exergame-based exercises.
  • Experimental: Home-based exercise group
    Participants in this group will perform home-based exercise sessions.

Primary Outcome Measure

Revised Fibromyalgia Impact Questionnaire [ Time Frame: Assessed at baseline, post-intervention (4 weeks), and at 8-week follow-up ]

Central Contacts

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