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.
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).
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.
Parallel
Immersive Virtual Reality
Other interventionParticipants 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.
Physical Activity
Other interventionParticipants 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.
Fibromyalgia Impact
Measured with Spanish version of the Revised Fibromyalgia Impact Questionnaire (FIQR). This 21-item instrument evaluates physical function (0-30), overall impact (0-20), and symptom severity (0-50), yielding a total score from 0 to 100, with higher scores indicating greater impairment.
Fatigue
Fatigue will be assessed using the Spanish version of the Multidimensional Fatigue Inventory (MFI-20), a validated 20-item self-report instrument measuring five dimensions: general and physical fatigue, reduced activity and motivation, and mental fatigue. Items are scored on a 5-point Likert scale, yielding total scores from 20 to 100, with higher scores indicating greater fatigue.
Sleep quality
Measured using the validated Spanish version of the Pittsburgh Sleep Quality Index (PSQI), a 19-item self-report measure evaluating sleep over the past month across seven components. Total scores range from 0 to 21, with higher scores indicating poorer sleep.
Pain distribution
Assessed with the Widespread Pain Index (WPI; 0 - 19), the 19 item body map component of the 2016 ACR Fibromyalgia criteria. Participants mark each anatomical region in which they have experienced pain during the previous week; the total score corresponds to the number of painful sites, ranging from 0 (no pain) to 19 (pain in all sites), with higher scores indicating a wider pain distribution and greater disease burden.
Symptom severity
Measured with the Symptom Severity Scale (SSS; 0 - 12), the second component of the 2016 ACR Fibromyalgia criteria. Participants rate the severity of fatigue, non-restorative sleep, cognitive problems and extent of additional somatic symptoms on 0 to 3 Likert items (0 = none, 3 = severe). Scores are summed to yield a total ranging from 0 (no symptoms) to 12 (maximal severity), with higher values reflecting a greater symptom severity.
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