Effects of Immersive Virtual Reality Exercise on Quality of Life, Cognitive Function, and Psychological Symptoms in Individuals With Fibromyalgia (VIR-FM)

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.

Study Overview

• Status: Completed
• Conditions: Fybromyalgia
• Intervention / Treatment: Behavioral: Virtual Reality Training; Behavioral: convencional exercise

Detailed Description

This study aims to evaluate the effectiveness of a physiotherapy intervention combined with immersive virtual reality on quality of life, cognitive function, psychological symptoms, and pain perception in individuals diagnosed with fibromyalgia. Fibromyalgia is a chronic condition characterized by widespread musculoskeletal pain, fatigue, cognitive impairment, and emotional disturbances, which significantly impact patients' quality of life. Given the limitations in adherence and effectiveness of conventional rehabilitation strategies, immersive virtual reality has emerged as a promising complementary tool, allowing patients to engage in therapeutic activities within controlled, interactive environments that may enhance motivation, adherence, and clinical outcomes.

This study is designed as a randomized controlled crossover clinical trial with pre-post assessments. Participants will be randomly assigned in a 1:1 ratio to one of two sequences: immersive virtual reality exercise followed by conventional exercise, or conventional exercise followed by immersive virtual reality. Each intervention phase will last six weeks, with sessions conducted twice per week. A washout period will be implemented between phases to minimize potential carryover effects. This crossover design allows each participant to serve as their own control, enabling both within-subject and between-condition comparisons.

Participants will be adults aged 18 years or older with a medical diagnosis of fibromyalgia according to the American College of Rheumatology criteria. They will be recruited from the Kinesiology Center of Universidad San Sebastián, Concepción, Chile, as well as through community outreach and patient associations. All participants will provide informed consent prior to enrollment, and the study protocol has been approved by the Scientific Ethics Committee of Universidad San Sebastián.

The intervention will consist of a structured physiotherapy program including aerobic exercise, coordination training, and relaxation techniques. In the experimental condition, these activities will be performed using immersive virtual reality systems (Meta Oculus Quest devices), incorporating guided exercise environments designed to stimulate motor and cognitive engagement. In the control condition, participants will perform the same exercises under therapist supervision without virtual reality. This design ensures comparability between conditions while isolating the effect of the immersive component.

Outcome measures will be assessed at baseline and after each intervention phase. Primary outcomes include quality of life, measured using the Fibromyalgia Impact Questionnaire-Revised (FIQ-R). Secondary outcomes include cognitive function assessed with the Montreal Cognitive Assessment (MoCA), psychological symptoms evaluated using the Depression Anxiety Stress Scales (DASS-21), pain intensity measured with the Numeric Rating Scale (NRS), mechanical pain sensitivity assessed through pressure pain thresholds (PPT), and sleep quality measured with the Jenkins Sleep Questionnaire. Sociodemographic and clinical variables will also be recorded.

Data analysis will be conducted using appropriate statistical methods, including descriptive analysis, normality testing, and inferential comparisons between conditions and time points. Paired t-tests or non-parametric equivalents will be applied as appropriate, and effect sizes will be calculated to estimate the magnitude of changes. A significance level of p < 0.05 will be used for all analyses.

This study is expected to contribute to the understanding of the role of immersive virtual reality as a complementary therapeutic tool in fibromyalgia rehabilitation, particularly in relation to clinical outcomes, patient experience, and treatment adherence.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Chile
  • Biobio
    • Concepción, Biobio, Chile, 41000
      • Universidad San Sebastián

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults aged 18 years or older
• Medical diagnosis of fibromyalgia according to the American College of Rheumatology (ACR) criteria
• Ability to understand and follow study instructions
• Willingness to participate and provide written informed consent

Exclusion Criteria:

• Pregnancy or breastfeeding
• Oncological pain
• Uncontrolled metabolic disorders
• History of vertigo or conditions that may be exacerbated by virtual reality use
• Any neurological or musculoskeletal condition that limits participation in exercise

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immersive VR → Conventional Exercise; Participants receive immersive virtual reality exercise followed by conventional exercise.	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.
Active Comparator: Conventional Exercise → Immersive VR; Participants receive conventional exercise followed by immersive virtual reality exercise.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	Quality of life in patients with fibromyalgia will be assessed using the Fibromyalgia Impact Questionnaire-Revised (FIQ-R), which evaluates the impact of fibromyalgia across three dimensions: difficulty in activities of daily living during the past week, overall impact of the disease during the past week, and symptom intensity during the past week. The total score ranges from 0 to 100, with higher values indicating greater symptom severity and a higher level of functional disability	At the beginning and end of the 6-week treatment period
Cognitive function	Cognitive function in both groups will be assessed using the MoCA questionnaire, a brief cognitive assessment tool that measures performance in domains such as memory, orientation, language, attention, executive function, and visuospatial abilities. The MoCA total score ranges from 0 to 30 points, with higher scores indicating better cognitive performance. A score of 26 or higher is generally considered within the normal cognitive range, although cutoff values may vary depending on age, education level, and clinical context.	At the beginning and end of the 6-week treatment period
Psychoemotional variables	Psychoemotional variables will be assessed using the DASS-21 questionnaire, which consists of 21 items designed to evaluate the presence of stress, anxiety, and/or depression. The instrument is divided into three subscales assessing depression, anxiety, and stress, with seven items assigned to each domain. Each item is rated on a 4-point Likert scale ranging from 0 ("did not apply to me at all") to 3 ("applied to me very much or most of the time"). Higher scores indicate greater severity of psychoemotional symptoms.	At the beginning and end of the 6-week treatment period
Sleep quality	Sleep quality was assessed using the Jenkins Sleep Questionnaire, a validated instrument designed to measure the frequency of sleep-related difficulties during the previous week, including problems falling asleep, nighttime awakenings, non-restorative sleep, and fatigue upon waking. The questionnaire consists of four items rated according to the frequency of symptoms experienced, with higher scores indicating poorer sleep quality and greater sleep disturbance.	At the beginning and end of the 6-week treatment period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
User experience	User experience was assessed using the Player Experience of Need Satisfaction (PENS) questionnaire, which measures dimensions related to the experience in interactive environments, including competence, autonomy, enjoyment/pleasure, intuitive control, and presence/immersion. This instrument provides information regarding the degree of psychological need satisfaction during interaction with virtual reality. The PENS questionnaire is composed of multiple items rated on a Likert-type scale, with higher scores indicating a more positive user experience and greater satisfaction across the evaluated dimensions.	At the beginning and end of the 6-week treatment period
Adherence to the intervention program	Adherence to the intervention program will be assessed as the percentage of completed sessions relative to the total number of scheduled sessions. Individual attendance at each session will be recorded to calculate treatment compliance. Adherence will be expressed as a percentage, with higher values indicating greater participation in the intervention program. This indicator will allow quantification of patient engagement and analysis of its relationship with the virtual reality experience and clinical outcomes.	At the beginning and end of the 6-week treatment period

Collaborators and Investigators

• Sponsor: gonzalo arias alvarez

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2025
• Primary Completion (Actual): February 16, 2026
• Study Completion (Actual): February 26, 2026

Study Registration Dates

• First Submitted: May 13, 2026
• First Submitted That Met QC Criteria: May 19, 2026
• First Posted (Actual): May 22, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: adherence; virtual reality; fibromialgia
• Other Study ID Numbers: 202605RVI; 171-25 (Registry Identifier: Scientific Ethics Committee, Universidad San Sebastián)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared due to ethical and confidentiality considerations. The study involves sensitive clinical information from patients with fibromyalgia, and data will be handled in accordance with institutional ethical guidelines and data protection regulations. Access to the dataset will be restricted to the research team, and all data will be stored securely in password-protected systems. No identifiable information will be disclosed to external researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No