Effects of Immersive Virtual Reality-Based Rehabilitation on Quality of Life, Sleep Quality, and Cognitive Function in Women With Fibromyalgia: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Fibromyalgia Impact (FIQR Total Score)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Fibromyalgia Impact (FIQR Total Score)
时间窗: 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
Global Cognitive Function (MoCA Total Score)
时间窗: 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.
Depression, Anxiety, and Stress Symptoms (DASS-21)
时间窗: 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.
Sleep Quality (Jenkins Sleep Questionnaire Score)
时间窗: 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.
次要结局
- 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)
研究者
gonzalo arias alvarez
Researcher in Musculoskeletal Rehabilitation
Universidad San Sebastián