IVR-based exercise program for fibromyalgia patients
Effectiveness of an Immersive Virtual Reality-based Therapeutic Exercise Program With Altered Visual Feedback in Patients With Fibromyalgia: A Randomized Controlled Trial
NA · Cardenal Herrera University · NCT06948500
This study tests if a new virtual reality exercise program can help people with fibromyalgia feel less pain and improve their overall well-being compared to regular exercises.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Cardenal Herrera University (other) |
| Locations | 1 site (Valencia, Valencia-valència) |
| Trial ID | NCT06948500 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a 6-week immersive virtual reality (IVR)-based therapeutic exercise program designed for patients with fibromyalgia. Participants will be randomly assigned to either an experimental group that performs exercises with altered visual feedback through IVR or a control group that performs the same exercises without IVR. The study aims to assess various outcomes, including pain intensity, fatigue, sleep quality, and overall quality of life, to determine the impact of this innovative approach on managing fibromyalgia symptoms.
Who should consider this trial
Good fit: Ideal candidates for this study are adults diagnosed with fibromyalgia who experience moderate pain levels.
Not a fit: Patients with comorbidities that contraindicate immersive virtual reality or exercise-based interventions may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the quality of life for fibromyalgia patients by enhancing exercise adherence and reducing symptoms.
How similar studies have performed: While non-immersive VR systems have shown benefits in symptom management, this specific approach using IVR with altered visual feedback is novel and has not been previously tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Valencia, Valencia-valència
- Juan Fco. Lisón — Valencia, Valencia-valència, Spain (RECRUITING)
Study contacts
- Principal investigator: Juan F Lisón, PhD — Cardenal Herrera University
- Study coordinator: JUAN FRANCISCO LISÓN PÁRRAGA, PhD
- Email: JUANFRAN@UCHCEU.ES
- Phone: 606503108
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Fibromyalgia, Immersive Virtual reality, Exercise, Pain