ClinicalTrials.gg
RecruitingNCT07304167Updated Jan 9, 2026

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

An interventional study of Exergaming and Home-based exercise in Fibromyalgia and Exergaming, sponsored by Halic University. Recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 30 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-01-09.

Sponsored by Halic University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Feb 2026, 8 months ago, but the record still lists the study as recruiting.
  • Started Dec 2025; still recruiting 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
30 Years to 70 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 195 studies in Fibromyalgia with a site in Turkey — 51 open to participants now, 55 under way, none of them phase 3. Fibromyalgia · Turkey.

Planned enrollment
100th of 104
20 · median 52
Started
2025
with 26 others
No phase
102 of 195
25 open now
Primary completion
2026-02
later than 22 of 54 live
Registered
154th of 195
by date

Among the 195 studies in Fibromyalgia with a site in Turkey, this one is the 100th largest by planned enrollment of the 104 interventional ones, is one of 27 that started in 2025, is one of 102 with no phase, reaches primary completion later than 22 of the 54 other live ones, and was the 154th registered.

By phase

195 studies; the count open now beside each. This study's row is marked.

No phasethis study102 · 25 open
Observational91 · 25 open
Phase 11 · 1 open
Phase 2/31 · 0 open

By the year they started

First in 2003; this study’s year is marked. 27 started in 2025.

Size and results

Median enrollment 52 across the 104 interventional studies, 100 across the 91 observational. Of the 126 that completed or were terminated, 3 (2%) have results posted.

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02

Study 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.

Read the detailed description

Fibromyalgia (FM) is a chronic disorder characterized by widespread pain, tenderness in specific musculoskeletal regions, fatigue, sleep disturbances, headaches, cognitive dysfunction, muscle weakness, postural instability, altered gait, and an increased risk of falls. Exercise has been reported to be one of the most effective non-pharmacological treatments for FM, and various types of exercise have been proposed. However, the evidence regarding which type of exercise provides optimal benefit remains limited.

Recently, exergame-based exercises - video game-assisted physical activities that combine interactive gaming with exercise - have gained attention as a novel and motivating rehabilitation approach. These programs have been shown to enhance adherence and engagement in different populations, including healthy adults, older individuals, and patients with neurological and musculoskeletal conditions. Nevertheless, research on the use of exergames in individuals with fibromyalgia is scarce, and no studies have been identified that use the Nintendo Switch Ring Fit Adventure game in this population.

This randomized clinical trial aims to compare the effects of an exergame-based exercise program and a home-based exercise program in women diagnosed with fibromyalgia. Participants will be randomly assigned to one of two groups: (1) the exergame group, performing supervised exercises using Ring Fit Adventure twice a week for four weeks, and (2) the home-based exercise group, performing a physiotherapist-prescribed home exercise program twice a week for four weeks.

All participants will be evaluated at baseline and after the 4-week intervention period, and reassessed following a 4-week detraining phase. Data obtained from this study will contribute to understanding the effects of exergame applications on pain, balance, functional mobility, and psychosocial outcomes in women with fibromyalgia. The results are expected to provide evidence supporting the use of exergame-based exercises as an enjoyable and effective approach within rehabilitation programs for individuals with fibromyalgia.

03

Conditions studied

  • Fibromyalgia
  • Exergaming

Keywords

  • Fibromyalgia
  • Exergaming
  • Exercise
  • Rehabilitation
04

Who can participate

Ages eligible
30 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 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.

Exclusion criteria

Exclusion Criteria:

  • 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
  • (BMI) greater than 29.9
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Exergame group

    Participants in this group will perform exergame-based exercises.

    Other: Exergaming

  • Experimental
    Home-based exercise group

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

    Other: Home-based exercise

Interventions

  • OtherExergaming

    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.

  • OtherHome-based exercise

    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).

06

What researchers measure

Primary outcomes

  1. 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.

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

  2. 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.

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

Secondary outcomes

  1. Visual Analog Scale (VAS)

    The Visual Analog Scale is a 100-mm horizontal line used to assess pain intensity. Participants are asked to mark a point on the line that represents their current level of pain. A score of 0 indicates "no pain," while 100 represents "the worst pain imaginable." The measurement is recorded in centimeters.

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

  2. 30-Second Sit-to-Stand Test

    A 45 cm-high armless chair and a stopwatch will be used. Participants sit upright with feet flat on the floor and arms crossed over the chest. On the "start" command, they stand up and sit down as many times as possible within 30 seconds. The total number of full stands is recorded as the score. The chair will be stabilized against a wall, and each participant will receive verbal instructions, a demonstration, and 2-3 practice trials.

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

  3. Timed Up and Go Test

    Functional mobility will be assessed by measuring the time taken to stand up from a chair, walk 3 meters, turn around, and sit down again. Three trials will be performed, and the best time recorded.

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

  4. Single-Leg Stance Test

    Static balance will be evaluated by asking participants to stand on one leg with arms crossed at the chest, eyes open, and without support. The duration of maintaining the position will be recorded in seconds. The test will stop at 120 seconds and will be performed bilaterally (Akıl et al., 2020; Springer et al., 2007).

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

  5. Berg Balance Scale

    The scale consists of 14 tasks scored from 0 to 4, with a maximum total of 56 points. Scores of 0-20 indicate balance impairment, 21-40 acceptable balance, and 41-56 good balance.

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

  6. Cognitive Exercise Therapy Approach Scale (BETY-BQ)

    This 30-item questionnaire, scored on a 5-point Likert scale (0-4), assesses biopsychosocial impact. Higher scores indicate greater impact.

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

  7. Short Form-12 (SF-12)

    The SF-12, a short version of the SF-36, assesses physical and mental health over the past four months. Higher scores reflect better health status. The Turkish version has been validated.

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2025 (actual). Primary completion is estimated for Feb 2026, 2 months after the start.

Of 436 non-industry interventional studies with no phase under Fibromyalgia, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 31. This study's planned 2 months is below that.

Counting every sponsor, half of 449 studies reached it within 15 months; a quarter within 6 and three quarters within 31.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 12, 2025
First posted
Dec 26, 2025
StartActual
Dec 15, 2025
Primary completionEst.
Feb 28, 2026
CompletionEst.
Mar 5, 2026
Last update
Jan 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07304167
Lead sponsor
Halic University
Responsible party
Ayşenur Çetinkaya (PT, PhD, Halic University) — Principal investigator
First posted
Dec 26, 2025
Start date
Dec 15, 2025
Primary completion
Feb 28, 2026 (estimated)
Completion
Mar 5, 2026 (estimated)
Last update
Jan 9, 2026

Study contacts

Ayşenur Çetinkaya, PhD
Contact
aysenurcetinkaya@halic.edu.tr
+905077218827
Ayşenur Çetinkaya
Contact
aysenurcetinkaya@halic.edu.tr
905077218827
Gülhan Fetin, PT
principal investigator · Halic University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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