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

NCT07605143 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-07-17

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • gonzalo arias alvarez

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-15
Primary Completion
2026-02-16
Completion
2026-02-26

Countries

  • Chile

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07605143 on ClinicalTrials.gov