Effectiveness of an IVR-based Therapeutic Exercise Program With Altered Visual Feedback in Fibromyalgia Patients
Effectiveness of an Immersive Virtual Reality-based Therapeutic Exercise Program With Altered Visual Feedback in Patients With Fibromyalgia: A Randomized Controlled Trial
Cardenal Herrera University
80 participants
May 5, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- 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 Criteria4
- 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.
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Interventions
Participants will wear an HTC Vive Pro head-mounted display with waist, hand and foot trackers during 60-min sessions, 2 times/week for 6 weeks (12 sessions). A gender- and skin-tone-matched first-person avatar will be calibrated to the user's anthropometrics and will mirror all real-time movements. Standardised audio instructions will be played through the headset; a virtual mirror will provide visual feedback. To facilitate lumbar mobility, two sensorimotor illusions will be applied: (1) Flexion illusion: Avatar upper-limb length will be reduced by ≈20%, encouraging greater trunk flexion; (2) Extension illusion: A virtual bar will rise with lumbar extension but will under-represent real movement by ≈10%. Both manipulations will update continuously throughout each repetition. A physiotherapist will supervise every session and will record adverse events.
Participants will undertake a 6-week therapeutic exercise program, consisting of two sessions per week (12 sessions total), with a primary objective of reducing fibromyalgia's impact on daily life. Each session will involve ten exercises performed in one or two sets each, depending on the week of the protocol. Exercise repetitions and intensity will be individualized using the Borg Rating of Perceived Exertion (RPE) scale (6-20), maintaining an intensity range of RPE 13-17. Specifically, intensity will start at RPE 14 (moderate) in Weeks 1-2, increase to RPE 15 (moderate-high) in Weeks 3-4, and peak at RPE 16 (high) in Weeks 5-6. No external load will be applied during the first three weeks to allow participants to adapt to the program, while progressive resistance will be introduced during the final three weeks according to individual capacity, ensuring a safe and gradual overload.
Locations(1)
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NCT06948500