FibromyalgiaNCT07304167
Investigation of the Effectiveness of a Exergame Program in Women With Fibromyalgia
A study testing Exergaming and Home-based exercise in people with Fibromyalgia and Exergaming, run by Halic University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 30 to 70 years, women only
- Conditions the study is for
- Fibromyalgia, Exergaming
- What is being tested?
- Exergaming and Home-based exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2025to 5 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 16Show fewer
- 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
- Body mass index (BMI) greater than 29.9
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Halic University
Istanbul
Ayşenur Çetinkaya, aysenurcetinkaya@halic.edu.tr
About this study
Official title: Investigation of the Effectiveness of a Video-Based Exercise (Exergame) Program in Women With Fibromyalgia: A Randomized Controlled Trial
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:
Read more
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.
- Conditions
- Fibromyalgia, Exergaming
- Being tested
- Exergaming, Home-based exercise
- Keywords
- Fibromyalgia, Exergaming, Exercise, Rehabilitation
- Medical subject headings
- Fibromyalgia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExergamingOther
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 exerciseOther
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 group | Role | What they receive |
|---|---|---|
| Exergame group | Experimental | Participants in this group will perform exergame-based exercises. Receives: Other: Exergaming |
| Home-based exercise group | Experimental | Participants in this group will perform home-based exercise sessions. Receives: Other: Home-based exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Assessed at baseline, post-intervention (4 weeks), and at 8-week follow-up
Secondary outcomes (7)
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.
Measured: Assessed at baseline, post-intervention (4 weeks), and at 8-week follow-up
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.
Measured: Assessed at baseline, post-intervention (4 weeks), and at 8-week follow-up
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.
Measured: Assessed at baseline, post-intervention (4 weeks), and at 8-week follow-up
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).
Measured: Assessed at baseline, post-intervention (4 weeks), and at 8-week follow-up
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.
Measured: Assessed at baseline, post-intervention (4 weeks), and at 8-week follow-up
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.
Measured: Assessed at baseline, post-intervention (4 weeks), and at 8-week follow-up
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.
Measured: Assessed at baseline, post-intervention (4 weeks), and at 8-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start15 Dec 2025
- Primary completion28 Feb 2026 (estimated)
- Study completion5 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Halic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşenur Çetinkaya, Halic University
- Investigators
- Gülhan Fetin, PT, Principal investigator, Halic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07304167
- Sponsor's protocol ID
- Acetinkaya007
- Status last verified
- Jan 2026
- First submitted
- 12 Dec 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of a Video-Based Exercise (Exergame) Program in Women With Fibromyalgia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07304167
- Acronym / sponsor ID
- Acetinkaya007
- Conditions
- Fibromyalgia, Exergaming
- Keywords
- Fibromyalgia, Exergaming, Exercise, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Halic UniversityUniversity, hospital or other
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 5 Mar 2026 (estimated)
- First posted
- 26 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exergame group | Experimental | Other: ExergamingParticipants in this group will perform exergame-based exercises. |
| Home-based exercise group | Experimental | Other: Home-based exerciseParticipants in this group will perform home-based exercise sessions. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExergamingParticipants 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. | Other | Exergame group |
| Home-based exerciseParticipants 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). | Other | Home-based exercise group |
Primary outcome
Revised Fibromyalgia Impact Questionnaire
Time frame: Assessed at baseline, post-intervention (4 weeks), and at 8-week follow-up
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.
Fibromyalgia Severity Scale
Time frame: Assessed at baseline, post-intervention (4 weeks), and at 8-week follow-up
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.
7 secondary outcomes
Visual Analog Scale (VAS)
Time frame: Assessed at baseline, post-intervention (4 weeks), and at 8-week follow-up
30-Second Sit-to-Stand Test
Time frame: Assessed at baseline, post-intervention (4 weeks), and at 8-week follow-up
Timed Up and Go Test
Time frame: Assessed at baseline, post-intervention (4 weeks), and at 8-week follow-up
Single-Leg Stance Test
Time frame: Assessed at baseline, post-intervention (4 weeks), and at 8-week follow-up
Berg Balance Scale
Time frame: Assessed at baseline, post-intervention (4 weeks), and at 8-week follow-up
Cognitive Exercise Therapy Approach Scale (BETY-BQ)
Time frame: Assessed at baseline, post-intervention (4 weeks), and at 8-week follow-up
Short Form-12 (SF-12)
Time frame: Assessed at baseline, post-intervention (4 weeks), and at 8-week follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gülhan Fetin, PT principal investigator
Halic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exergaming and Home-based exercise in people with Fibromyalgia and Exergaming, run by Halic University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ayşenur Çetinkaya, PhD (+905077218827, aysenurcetinkaya@halic.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Revised Fibromyalgia Impact Questionnaire (time frame: Assessed at baseline, post-intervention (4 weeks), and at 8-week follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.