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

Phase

N/A

Condition

Fibromyalgia

Treatment

Physical Activity

Immersive Virtual Reality

Clinical Study ID

NCT06948500

UNIVERSITY CARDENAL HERRERA-80

CEEI25/643

Ages 18-80
All Genders

Study 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

Inclusion Criteria:

Adults diagnosed with fibromyalgia according to any of the classification criteriaestablished 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 the Visual Analogue Scale (VAS).

Exclusion

Exclusion Criteria:

Presence of comorbidities and/or symptoms that constitute a contraindication forimmersive virtual reality or exercise-based interventions;
Presence of medical conditions that may interfere with study outcomes, such asvisual, auditory, perceptual, or sensory disorders;
Use of medications that could potentially affect study results;
Engagement in another therapeutic physical activity program during the interventionperiod, or any modifications to existing therapies (including medication or physicaltherapy) throughout the study.

Study Design

Physical Activity

April 01, 2025

December 10, 2026

Study Description

Fibromyalgia is a chronic and multifactorial condition marked by widespread pain, fatigue, sleep disturbances, and various neurocognitive and psychosomatic symptoms, severely impacting quality of life and increasing healthcare costs. Although therapeutic exercise is a first-line, evidence-based treatment, its implementation is often hindered by low adherence, kinesiophobia, and maladaptive pain beliefs. Immersive virtual reality (IVR) has gained attention as a novel approach to enhance exercise efficacy through sensory immersion, cognitive distraction, and embodiment. Visual feedback manipulation in IVR-such as creating the illusion of reduced movement-has been shown to increase range of motion and engagement without intensifying perceived pain or effort. While non-immersive VR systems have shown benefits in symptom management and adherence, IVR appears to offer superior outcomes via real-time multisensory integration. However, no studies have yet investigated the clinical effects of integrating IVR with altered visual input during therapeutic exercise in FM. This will be a randomized controlled trial evaluating a 6-week IVR-based exercise program that modulates visual input to create the perception of reduced movement in FM patients. The experimental group will be compared to a control group following the same exercise program without IVR. Outcome measures include pain intensity, fatigue, sleep quality, kinesiophobia, functional capacity, symptom severity, and user experience. This study seeks to fill a critical gap in FM rehabilitation by testing whether IVR-enhanced exercise with visual modulation reduces the impact of fibromyalgia on patients' daily lives and improves physiological, psychological, and physical outcomes compared to traditional exercise approaches without IVR.

Connect with a study center

Juan Fco. Lisón
València, Valencia-valència 46006
Spain
Active - Recruiting

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