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

NCT07605143 | Completed

• 2 other identifiers: 202605RVI171-25
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

adherence; fibromialgia; virtual reality

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• User experience

  At the beginning and end of the 6-week treatment period

• Adherence to the intervention program

  At the beginning and end of the 6-week treatment period

Study Arms (2)

Immersive VR → Conventional Exercise

EXPERIMENTAL

Participants receive immersive virtual reality exercise followed by conventional exercise.

Behavioral: Virtual Reality Training; Behavioral: convencional exercise

Conventional Exercise → Immersive VR

ACTIVE COMPARATOR

Participants receive conventional exercise followed by immersive virtual reality exercise.

Behavioral: Virtual Reality Training; Behavioral: convencional exercise

Interventions

Virtual Reality Training BEHAVIORAL

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.

Conventional Exercise → Immersive VR; Immersive VR → Conventional Exercise

convencional exercise BEHAVIORAL

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.

Conventional Exercise → Immersive VR; Immersive VR → Conventional Exercise

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• gonzalo arias alvarez: lead

Study Sites (1)

Universidad San Sebastián

Concepción, Biobio, 41000, Chile

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Researcher in Musculoskeletal Rehabilitation

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: May 22, 2026
• Study Start: December 15, 2025
• Primary Completion: February 16, 2026
• Study Completion: February 26, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)