Fibromyalgia Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 30
Maximum Age: 70
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Turkey
Halic University
RECRUITING
Istanbul
Contact Information
Primary
Ayşenur Çetinkaya, PhD
aysenurcetinkaya@halic.edu.tr
+905077218827
Backup
Ayşenur Çetinkaya
aysenurcetinkaya@halic.edu.tr
905077218827
Time Frame
Start Date: 2025-12-15
Estimated Completion Date: 2026-03-05
Participants
Target number of participants: 20
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Halic University

This content was sourced from clinicaltrials.gov