NCT06948500 Effectiveness of an IVR-based Therapeutic Exercise Program With Altered Visual Feedback in Fibromyalgia Patients
| NCT ID | NCT06948500 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cardenal Herrera University |
| Condition | Fibromyalgia |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-05-05 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2025-05-05 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The primary aim of this randomized controlled trial is to determine the efficacy of a 6-week immersive virtual reality (IVR)-based therapeutic exercise intervention, which manipulates visual proprioceptive input during exercise, for patients diagnosed with fibromyalgia (FM). Participants will be randomly allocated into two groups: an experimental group performing therapeutic exercises integrated with IVR featuring modified visual feedback, and a control group executing identical exercises without IVR integration. The primary outcome will assess the impact of fibromyalgia on daily activities, while secondary outcomes will comprehensively evaluate fatigue, sleep quality, severity of fibromyalgia symptoms, health-related quality of life, anxiety and depressive symptoms, fear-avoidance beliefs, pain catastrophizing, kinesiophobia, indicators of central sensitization, lumbar spine flexion and extension range of motion, somatosensory function, body perception distortion, muscle strength of the handgrip and quadriceps, functional mobility, lower limb strength, behavioral regulation concerning exercise adherence, and patient-reported experiences regarding IVR use. This trial seeks to elucidate whether incorporating IVR into therapeutic exercise protocols reduces the impact of fibromyalgia on patients' daily lives and improves physiological, psychological, and physical outcomes compared to traditional exercise approaches without IVR.
Eligibility Criteria
Inclusion Criteria: * Adults diagnosed with fibromyalgia according to any of the classification criteria established by the American College of Rheumatology (ACR), including those from 1990, 2010, 2011, or 2016; * Ability to communicate effectively with the research staff; * A self-reported pain intensity score of ≥3 on a 11-point Numerical Pain Rating Scale (NRS-11). Exclusion Criteria: * Presence of comorbidities and/or symptoms that constitute a contraindication for immersive virtual reality or exercise-based interventions; * Presence of medical conditions that may interfere with study outcomes, such as visual, auditory, perceptual, or sensory disorders; * Use of medications that could potentially affect study results; * Engagement in another therapeutic physical activity program during the intervention period, or any modifications to existing therapies (including medication or physical therapy) throughout the study.
Contact & Investigator
Juan F Lisón, PhD
PRINCIPAL INVESTIGATOR
Cardenal Herrera University
Frequently Asked Questions
Who can join the NCT06948500 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Fibromyalgia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06948500 currently recruiting?
Yes, NCT06948500 is actively recruiting participants. Contact the research team at JUANFRAN@UCHCEU.ES for enrollment information.
Where is the NCT06948500 trial being conducted?
This trial is being conducted at Valencia, Spain.
Who is sponsoring the NCT06948500 clinical trial?
NCT06948500 is sponsored by Cardenal Herrera University. The principal investigator is Juan F Lisón, PhD at Cardenal Herrera University. The trial plans to enroll 80 participants.
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