Effects of Immersive Virtual Reality in Fibromyalgia

NCT06658223 | Enrolling By Invitation DMC

• 1 other identifier: 3
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Fibromyalgia is considered a disease of unknown etiology, which It affects between 2 to 5% of the population in developed countries, mostly women, diagnosed mainly between 40 and 50 years of age, and whose main characteristic is generalized presence of musculoskeletal pain. Although the most described symptoms are multiple sensitive areas in trigger points, fatigue and cognitive dysfunction, this syndrome is associated commonly to anxiety disorders, depression and catastrophizing. In Chile, consultations specific cases of rheumatology due to Fibromyalgia reach 26.7%, with a similar reality in the commune of Concepción, as a result of which the need arises to implement a strategy different and innovative, in which an environment can be generated in which the user practices motor and cognitive strategies in different contexts, whether work or home, to through virtual reality, which has proven to be a promising tool in this group of the population, since by entering a controlled virtual environment, different techniques, taking them out of the conventional treatment box. In this way, it may include relaxation exercises, cognitive behavioral therapy, and physical activities adapted. This interaction may improve cognitive function, reduce anxiety symptoms, reduce painful perception associated with your health condition and improve your quality of life. Although there is knowledge and favorable experiences in its use, there is little information about the effects and the scope that it can have in patients with fibromyalgia. For this reason, it is proposed to carry out an investigation applying a Kinesiological treatment complemented with virtual reality. in patients with this disease. Therefore, the research question arises: What is the effectiveness of a kinesiological treatment, complemented with immersive virtual reality, on quality of life, cognitive and psychoemotional function in patients with fibromyalgia?

Conditions

Fibromyalgia (FM)

Keywords

FIBROMYALGIA; VIRTUAL REALITY; EXERGAME; EXERCISE

Outcome Measures

Primary Outcomes (1)

• Impact of Fibromyalgia on Quality of Life

  The Impact of Fibromyalgia on Quality of Life was assessed using the FIQ-R instrument. This self-administered test measures difficulty in activities of daily living in the last week, the overall influence of the disease in the last week, and the severity of symptoms in the past week. Total scores range from 0 to 100, with higher scores indicating more severe symptoms and disability.

  SIX WEEKS

Secondary Outcomes (3)

• Cortisol

  SIX WEEKS

• Stress, anxiety and depression

  SIX WEEKS

• Cognitive function

  SIX WEEKS

Study Arms (1)

Exercise with virtual reality

EXPERIMENTAL

The virtual reality program consisted of twelve sessions (2 per week for six weeks) of 10 min warm-up plus 15 minutes of exercise with the FitXR game (developed by FITAR LIMITED) on the Oculus Quest 2™ device. The warm-up consisted of moderate-intensity aerobic exercise on a cycle ergometer. The BORG CR-10 perceived exertion scale was used to determine this intensity. Subsequently, they continued with the FitXR game, starting with a 5-minute phase of muscular activation and global movements of their limbs. They performed eye-hand coordination exercises, hitting balls that came to the person at different speeds, and ended with muscle stretching and slow breathing. These exercises presented different difficulty levels and were adjusted to the person's condition. In the same way, as the game developed, it was possible to increase the level and thus increase its complexity.

Other: Exercise with virtual reality

Interventions

Exercise with virtual reality OTHER

The virtual reality program consisted of twelve sessions (2 per week for six weeks) of 10 min warm-up plus 15 minutes of exercise with the FitXR game (developed by FITAR LIMITED) on the Oculus Quest 2™ device. The warm-up consisted of moderate-intensity aerobic exercise on a cycle ergometer. The BORG CR-10 perceived exertion scale was used to determine this intensity. Subsequently, they continued with the FitXR game, starting with a 5-minute phase of muscular activation and global movements of their limbs. They performed eye-hand coordination exercises, hitting balls that came to the person at different speeds, and ended with muscle stretching and slow breathing. These exercises presented different difficulty levels and were adjusted to the person's condition. In the same way, as the game developed, it was possible to increase the level and thus increase its complexity.

Exercise with virtual reality

Eligibility Criteria

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

You may qualify if:

• Males and females
• over 18 years of age
• with a diagnosis of fibromyalgia issued by a medical professional under the ACR criteria (2016)

You may not qualify if:

• Subjects were excluded from the study when they presented pregnancy or lactation
• oncologic pain
• uncontrolled metabolic disorder
• vertigo or similar condition or any cognitive impairment that hinders the understanding of the informed consent.

Sponsors & Collaborators

• Universidad San Sebastián: lead

Study Sites (1)

Universidad San Sebastián

Concepción, Bio-bio, 4080871, Chile

Location

MeSH Terms

Conditions

Fibromyalgia; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• GONZALO J ARIAS-ALVAREZ

  Universidad San Sebastián

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mrs

Model Details: Longitudinal quasi-experimental study. The application of the study protocol will be carried out, in its entirety, at the kinesiology center of the Universidad San Sebastián, Concepción campus.

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: October 26, 2024
• Study Start: September 2, 2024
• Primary Completion: December 31, 2024
• Study Completion: February 28, 2025
• Last Updated: October 26, 2024

Record last verified: 2024-10

Locations

CL (1)