Effectiveness of an IVR-based Therapeutic Exercise Program With Altered Visual Feedback in Fibromyalgia Patients

NCT06948500 | Recruiting

• 2 other identifiers: UNIVERSITY CARDENAL HERRERA-80CEEI25/643
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

Fibromyalgia; Immersive Virtual reality; Exercise; Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  At six weeks

Secondary Outcomes (22)

• Fatigue

  At six weeks

• Sleep quality

  At six weeks

• Pain distribution

  At six weeks

• Symptom severity

  At six weeks

• Change in Fibromyalgia Survey Diagnostic Criteria (FSDC) total score

  At six weeks

Study Arms (2)

Immersive Virtual Reality + Physical Activity

EXPERIMENTAL

A set of ten therapeutic exercises using IVR will be implemented. These exercises are designed to enhance strength, stability, mobility, and flexibility in the abdomino-lumbo-pelvic region and lower limbs. During each exercise, participants will wear IVR goggles that modify visual proprioceptive feedback by altering the perceived range of movement. Specifically, the visual input provided by the IVR system will create a discrepancy between actual physical movement and perceived motion, allowing participants to visually experience movements differently from reality.

Other: Immersive Virtual Reality; Other: Physical Activity

Physical Activity

ACTIVE COMPARATOR

Control-group participants will perform the same 6-week therapeutic-exercise program as the experimental group; the only difference will be the absence of the IVR. Training methodology, load progression, assessment procedures, and physiotherapist supervision will remain identical, ensuring comparability between groups.

Other: Physical Activity

Interventions

Immersive Virtual Reality OTHER

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.

Immersive Virtual Reality + Physical Activity

Physical Activity OTHER

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.

Immersive Virtual Reality + Physical Activity; Physical Activity

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cardenal Herrera University: lead

Study Sites (1)

Juan Fco. Lisón

Valencia, Valencia-valència, 46006, Spain

RECRUITING

MeSH Terms

Conditions

Fibromyalgia; Motor Activity; Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Juan F Lisón, PhD

  Cardenal Herrera University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

JUAN FRANCISCO LISÓN PÁRRAGA, PhD

CONTACT

606503108; JUANFRAN@UCHCEU.ES

Juan J Amer, PhD

CONTACT

96136900; juanjoamer@uchceu.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair Professor

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: April 29, 2025
• Study Start: May 5, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 10, 2027
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

ES (1)