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COMPLETED
NCT07605143
NA

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

Sponsor: gonzalo arias alvarez

View on ClinicalTrials.gov

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.

Official 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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2025-12-15

Completion Date

2026-02-26

Last Updated

2026-07-17

Healthy Volunteers

No

Conditions

Interventions

BEHAVIORAL

Immersive Virtual Reality Exercise

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.

BEHAVIORAL

convencional exercise

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.

Locations (1)

Universidad San Sebastián

Concepción, Biobio, Chile