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Completed

NCT Number: NCT07605143

Effects of Immersive Virtual Reality-Based Rehabilitation on Quality of Life, Sleep Quality, and Cognitive Function in Women With Fibromyalgia

Fibromyalgia is a chronic pain condition characterized by widespread musculoskeletal pain, fatigue, sleep disturbances, cognitive complaints, and psychoemotional symptoms, leading to functional impairment and reduced quality of life. Although exercise is recommended as a first-line non-pharmacological treatment, maintaining long-term adherence remains a major challenge.

Immersive virtual reality (IVR) has emerged as a promising approach to increase motivation and engagement during rehabilitation by integrating therapeutic exercise with interactive virtual environments. This randomized controlled trial evaluated the effects of a six-week exercise program delivered through immersive virtual reality compared with conventional exercise in women with fibromyalgia.

Participants were randomly assigned to either an IVR exercise group or a conventional exercise group. Clinical outcomes were assessed at baseline and after the intervention, including fibromyalgia-related impact, global cognitive screening performance, sleep quality, and psychoemotional symptoms. Treatment adherence and user experience were also evaluated to explore their association with clinical outcomes.

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Key information

Conditions

Fybromyalgia

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Universidad San Sebastián

Concepción, Biobio, 41000, Chile

About this study

Fibromyalgia is a chronic pain syndrome characterized by widespread musculoskeletal pain, fatigue, sleep disturbances, cognitive dysfunction, and psychoemotional symptoms, resulting in substantial reductions in physical function and health-related quality of life. Although therapeutic exercise is considered a core component of fibromyalgia management, maintaining long-term adherence to exercise programs remains challenging due to pain exacerbation, fatigue, and reduced motivation.

Immersive virtual reality (IVR) has emerged as an innovative rehabilitation strategy that integrates therapeutic exercise with interactive virtual environments. By providing real-time visual feedback, immersive environments, and gamified exercise tasks, IVR may improve motivation, enjoyment, and engagement during rehabilitation while promoting adherence to structured exercise programs.

The present study was designed as a two-arm parallel-group randomized controlled trial comparing an immersive virtual reality exercise program with a conventional exercise program in women diagnosed with fibromyalgia according to the 2016 American College of Rheumatology diagnostic criteria. Participants were randomly allocated in a 1:1 ratio to either intervention and completed a supervised six-week rehabilitation program consisting of two sessions per week.

Participants allocated to the IVR group performed a combined intervention consisting of aerobic exercise followed by immersive virtual reality exercise using Meta Quest 2 head-mounted displays (Meta Platforms, Menlo Park, CA, USA) and the FitXR® platform (AeroBox modality). Participants allocated to the control group performed a conventional exercise program matched for treatment frequency and session duration. All intervention sessions were supervised by a physiotherapist trained in the study protocol.

Clinical assessments were performed at baseline and immediately after completion of the intervention. The predefined primary outcomes included fibromyalgia-related impact (FIQR), global cognitive screening performance (MoCA), psychoemotional symptoms (DASS-21), and sleep quality (Jenkins Sleep Questionnaire). Secondary outcomes included treatment adherence and user experience, assessed using the Player Experience of Need Satisfaction (PENS) questionnaire in participants allocated to the IVR group.

The primary objective of the randomized controlled trial was to compare the effects of immersive virtual reality exercise and conventional exercise on clinical outcomes in women with fibromyalgia. In addition, the study was designed to explore whether user experience during immersive virtual reality was associated with treatment adherence and changes in clinical outcomes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female participants aged 18 years or older
  • Clinical diagnosis of fibromyalgia according to the 2016 American College of Rheumatology (ACR) diagnostic criteria
  • Ability to understand and follow study procedures
  • Provision of written informed consent

Exclusion criteria

  • Pregnancy or breastfeeding
  • Cancer-related pain
  • Uncontrolled metabolic disorders
  • History of vertigo, vestibular disorders, or any condition that could be aggravated by immersive virtual reality exposure
  • Neurological or musculoskeletal conditions that contraindicated participation in therapeutic exercise

Treatment and study plan

Immersive Virtual Reality Exercise

Behavioral

Participants performed immersive virtual reality exercise using Meta Quest 2 head-mounted displays (Meta Platforms, USA) and the FitXR® platform (AeroBox modality). The intervention consisted of gamified boxing-based exercises requiring upper-limb movements, straight punches, hooks, uppercuts, lateral displacements, weight shifting, squatting, and obstacle avoidance within an immersive virtual environment. Participants received continuous real-time visual feedback while exercise difficulty progressed automatically according to individual performance. All sessions were supervised by a physical therapist.

Other names: Virtual Reality Training

convencional exercise

Behavioral

Participants performed a supervised conventional exercise program matched to the experimental intervention for treatment frequency, session duration, therapist supervision, and prescribed exercise intensity. The intervention included aerobic exercise followed by therapist-guided mobility, coordination, strengthening, balance, and functional movement exercises, concluding with stretching and breathing exercises.

Primary outcomes

  1. Fibromyalgia Impact (FIQR Total Score)

    Time frame: Baseline and immediately after completion of the 6-week intervention

    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

  2. Global Cognitive Function (MoCA Total Score)

    Time frame: Baseline and immediately after completion of the 6-week intervention

    Global 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.

  3. Depression, Anxiety, and Stress Symptoms (DASS-21)

    Time frame: Baseline and immediately after completion of the 6-week intervention

    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.

  4. Sleep Quality (Jenkins Sleep Questionnaire Score)

    Time frame: Baseline and immediately after completion of the 6-week intervention

    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.

Secondary outcomes

  1. User Experience (Player Experience of Need Satisfaction [PENS])

    Time frame: Immediately after completion of the 6-week intervention

    User experience will be assessed using the Player Experience of Need Satisfaction (PENS) questionnaire, which measures dimensions related to interactive virtual environments, including competence, autonomy, intuitive control, enjoyment, and presence/immersion. The questionnaire provides information on psychological need satisfaction during immersive virtual reality exercise. PENS will be administered only to participants allocated to the immersive virtual reality group immediately after completion of the intervention. Higher scores indicate a more positive user experience and greater satisfaction across the evaluated dimensions.

  2. Treatment Adherence (Percentage of Completed Sessions)

    Time frame: Baseline and immediately after completion of the 6-week intervention

    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 quantify participant engagement and will be used to explore its association with user experience and clinical outcomes.

Sponsors and collaborators

Lead sponsor

gonzalo arias alvarez

Other

Registry information

Official study title

Effects of Immersive Virtual Reality-Based Rehabilitation on Quality of Life, Sleep Quality, and Cognitive Function in Women With Fibromyalgia: A Randomized Controlled Trial

Acronym: VIR-FM

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 22, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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