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

NCT07605143 | Completed

• 2 other identifiers: 202605RVI171-25
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fybromyalgia

Keywords

adherence; fibromialgia; virtual reality

Outcome Measures

Primary Outcomes (4)

• Fibromyalgia Impact (FIQR Total Score)

  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

  Baseline and immediately after completion of the 6-week intervention

• Global Cognitive Function (MoCA Total Score)

  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.

  Baseline and immediately after completion of the 6-week intervention

• Depression, Anxiety, and Stress Symptoms (DASS-21)

  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.

  Baseline and immediately after completion of the 6-week intervention

• Sleep Quality (Jenkins Sleep Questionnaire Score)

  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.

  Baseline and immediately after completion of the 6-week intervention

Secondary Outcomes (2)

• User Experience (Player Experience of Need Satisfaction [PENS])

  Immediately after completion of the 6-week intervention

• Treatment Adherence (Percentage of Completed Sessions)

  Baseline and immediately after completion of the 6-week intervention

Study Arms (2)

Immersive Virtual Reality Exercise

EXPERIMENTAL

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 and automated performance reinforcement while exercise difficulty progressed according to individual performance. All sessions were supervised by a physical therapist.

Behavioral: Immersive Virtual Reality Exercise

Conventional Exercise

ACTIVE COMPARATOR

Participants performed a supervised conventional exercise program matched to the experimental intervention for treatment frequency, session duration, therapist supervision, and overall exercise intensity. Sessions consisted of moderate-intensity aerobic exercise followed by a structured exercise circuit including boxing movements toward therapist-guided targets or a punching bag, squatting exercises, lateral trunk displacement tasks, and progressive coordination exercises, followed by cool-down stretching and breathing exercises.

Behavioral: convencional exercise

Interventions

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.

Also known as: Virtual Reality Training

Immersive Virtual Reality Exercise

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.

Conventional Exercise

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

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
• Masking Details: Outcome assessments were performed by an assessor blinded to treatment allocation. Due to the nature of the intervention, participants and treating physiotherapists were not blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Researcher in Musculoskeletal Rehabilitation

Model Details: Participants were randomly assigned in a 1:1 ratio to either an immersive virtual reality exercise group or a conventional exercise group. Both groups completed a supervised six-week intervention consisting of two sessions per week. Clinical outcomes were assessed at baseline and immediately after completion of the intervention.

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: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)