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

NCT07304167 | Recruiting

• 1 other identifier: Acetinkaya007
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fibromyalgia; Exergaming

Keywords

Fibromyalgia; Exergaming; Exercise; Rehabilitation

Outcome Measures

Primary Outcomes (2)

• Revised Fibromyalgia Impact Questionnaire

  The Revised Fibromyalgia Impact Questionnaire will be used to assess the impact of fibromyalgia (FM) on patients. The questionnaire consists of 21 items. All items are based on an 11-point numerical rating scale ranging from 0 to 10, where 10 indicates the worst possible condition. It comprises three domains: function, overall impact, and symptoms. The total score for the function domain (range 0-90) is divided by 3; the overall impact domain (range 0-20) is left unchanged; and the total score for the symptom domain (range 0-100) is divided by 2. The overall Revised Fibromyalgia Impact Questionnaire score is the sum of these three domain scores.

  Assessed at baseline, post-intervention (4 weeks), and at 8-week follow-up

• Fibromyalgia Severity Scale

  The Fibromyalgia Severity Scale is calculated by summing the scores of the Widespread Pain Index (WPI) and the Symptom Severity Scale (SSS). The maximum total score is 31 (19 + 12 = 31). A total score below 12 is generally not considered indicative of fibromyalgia.

  Assessed at baseline, post-intervention (4 weeks), and at 8-week follow-up

Secondary Outcomes (7)

• Visual Analog Scale (VAS)

  Assessed at baseline, post-intervention (4 weeks), and at 8-week follow-up

• 30-Second Sit-to-Stand Test

  Assessed at baseline, post-intervention (4 weeks), and at 8-week follow-up

• Timed Up and Go Test

  Assessed at baseline, post-intervention (4 weeks), and at 8-week follow-up

• Single-Leg Stance Test

  Assessed at baseline, post-intervention (4 weeks), and at 8-week follow-up

• Berg Balance Scale

  Assessed at baseline, post-intervention (4 weeks), and at 8-week follow-up

Study Arms (2)

Exergame group

EXPERIMENTAL

Participants in this group will perform exergame-based exercises.

Other: Exergaming

Home-based exercise group

EXPERIMENTAL

Participants in this group will perform home-based exercise sessions.

Other: Home-based exercise

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.

Exergame group

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).

Home-based exercise group

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Halic University: lead

Study Sites (1)

Halic University

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Fibromyalgia; Motor Activity

Interventions

Exergaming

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Gülhan Fetin, PT

  Halic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayşenur Çetinkaya, PhD

CONTACT

+905077218827; aysenurcetinkaya@halic.edu.tr

Ayşenur Çetinkaya

CONTACT

905077218827; aysenurcetinkaya@halic.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT, PhD

Study Record Dates

• First Submitted: December 12, 2025
• First Posted: December 26, 2025
• Study Start: December 15, 2025
• Primary Completion: February 28, 2026
• Study Completion: March 5, 2026
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)