Actively Recruiting

Phase Not Applicable
Age: 30Years - 70Years
FEMALE
NCT07304167

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

Led by Halic University · Updated on 2026-01-09

20

Participants Needed

1

Research Sites

11 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 30Years - 70Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged between 30 and 70 years
  • Diagnosed with fibromyalgia
  • Willing to participate and able to sign informed consent
  • Meet 2016 American College of Rheumatology diagnostic criteria: Widespread Pain Index 63 7 and Symptom Severity Scale 63 5, or WPI 4-6 and SSS 63 9
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding
  • Advanced locomotor system diseases contraindicating exercise (e.g., arthritis, osteoarthritis, uric acid disorders)
  • Epilepsy
  • History of severe headache
  • Neurological disorders
  • Peripheral neuropathy
  • Severe cardiovascular diseases (e.g., endocranial hypertension, uncontrolled hypertension, heart failure, pacemaker)
  • Orthopedic disorders preventing physical activity
  • Rheumatologic diseases other than fibromyalgia
  • Pneumothorax
  • Neoplasia
  • Surgery within last four months
  • Severe psychiatric illness (e.g., uncontrolled depression, anxiety, personality disorders, dementia, cognitive impairment from substance abuse)
  • Alcohol dependence or use of psychoactive drugs or narcotics
  • Participation in physical activity program within two months before study start
  • Body mass index over 29.9

AI-Screening

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Trial Site Locations

Total: 1 location

1

Halic University

Istanbul, Turkey (Türkiye)

Actively Recruiting

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Research Team

A

Ayşenur Çetinkaya, PhD

CONTACT

A

Ayşenur Çetinkaya

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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