Effects of Immersive Virtual Reality Exercise on Quality of Life, Cognitive Function, and Psychological Symptoms in Individuals With Fibromyalgia

NCT07605143 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-05-22

No results posted yet for this study

Summary

Fibromyalgia is considered a condition of unknown etiology, affecting approximately 2-5% of the population in developed countries, predominantly women, and is most commonly diagnosed between the ages of 40 and 50. Its main characteristic is the presence of widespread musculoskeletal pain. Although the most frequently reported symptoms include multiple tender points, fatigue, and cognitive dysfunction, this syndrome is also commonly associated with anxiety, depression, and pain catastrophizing.

In Chile, fibromyalgia accounts for up to 26.7% of private rheumatology consultations, with a similar scenario observed in the city of Concepción. This highlights the need to implement innovative therapeutic strategies that allow patients to practice motor and cognitive skills in various contexts, including occupational and domestic environments. In this regard, virtual reality has emerged as a promising tool for this population, as it provides a controlled virtual environment where patients can engage in different therapeutic techniques, moving beyond conventional treatment approaches.

Through this approach, interventions may include relaxation exercises, cognitive-behavioral therapy, and adapted physical activities. Such interaction may improve cognitive function, reduce symptoms of anxiety, decrease pain perception associated with the condition, and enhance overall quality of life.

This study aims to evaluate the effectiveness of a physiotherapy intervention combined with immersive virtual reality on quality of life, cognitive function, and psychological symptoms in patients diagnosed with fibromyalgia. This study corresponds to a randomized controlled crossover clinical trial in which participants will be randomly assigned to one of two groups: Group A will initiate the intervention with physical exercise using immersive virtual reality, while Group B will begin with physical exercise without virtual reality support (control condition). After completing the first intervention period, a crossover will be performed, such that Group A will continue with exercise without virtual reality and Group B will receive the immersive virtual reality intervention. In this way, all participants will experience both exercise modalities, allowing for both within- and between-subject comparisons. A washout period will be included between phases to minimize potential carryover effects. Each group will consist of 21 participants recruited from the Kinesiology Center of Universidad San Sebastián. Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA), psychological variables will be evaluated using the Depression Anxiety Stress Scales (DASS-21), and quality of life will be measured using the Fibromyalgia Impact Questionnaire-Revised (FIQ-R). All outcomes will be assessed at baseline and after each intervention phase.

Conditions

  • Fybromyalgia

Interventions

BEHAVIORAL

Virtual Reality Training

Participants will perform a structured physiotherapy program consisting of moderate-intensity aerobic exercise, coordination training, and relaxation techniques, delivered using immersive virtual reality systems (Meta Oculus Quest). Each session will last approximately 60 minutes and will be conducted twice per week for 6 weeks. The program includes 10 minutes of aerobic exercise (cycle ergometer), followed by immersive virtual reality activities comprising 5 minutes of warm-up, 10 minutes of coordination exercises, and 5 minutes of cool-down, concluding with stretching and breathing exercises. Exercise intensity will be monitored using the modified Borg scale. The virtual reality environment is designed to promote motor and cognitive engagement within an interactive setting.

BEHAVIORAL

convencional exercise

Participants will perform the same structured physiotherapy program consisting of moderate-intensity aerobic exercise, coordination training, and relaxation techniques without the use of immersive virtual reality. Each session will last approximately 60 minutes and will be conducted twice per week for 6 weeks. The program includes 10 minutes of aerobic exercise (cycle ergometer), followed by therapist-guided exercises including 5 minutes of warm-up, 10 minutes of coordination exercises, and 5 minutes of cool-down, concluding with stretching and breathing exercises. Exercise intensity will be monitored using the modified Borg scale.

Sponsors & Collaborators

  • gonzalo arias alvarez

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-15
Primary Completion
2026-02-16
Completion
2026-02-26

Countries

  • Chile

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07605143 on ClinicalTrials.gov