Effects of Immersive Virtual Reality on Quality of Life, Stress, Anxiety, Depression and Grip Strength in Fibromyalgia: A Pilot Study

NCT06606132 | Completed DMC

• 1 other identifier: 2
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this pilot study is to determine the effectiveness of an exercise program based on virtual reality on the impact on quality of life, stress, anxiety, depression and grip strength in people with fibromyalgia. The main questions that are intended to be answered are: Does therapeutic exercise complemented with immersive virtual reality reduce the impact on quality of life, stress, anxiety and depression and grip strength in people with Fibromyalgia? The investigators will conduct a pilot study with pre- and post-treatment evaluations. This treatment will consist of 12 sessions of aerobic exercise plus exercise with immersive virtual reality.

Conditions

Fibromyalgia (FM)

Keywords

fibromyalgia; virtual reality; 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 (2)

• Stress, anxiety and depression

  six weeks

• Handgrip strength

  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

Interventions

Exercise 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.

Also known as: virtual reality

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, 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, Master

  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: Sr.

Model Details: A single-arm, pre-post-test pilot study was designed

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: September 20, 2024
• Study Start: June 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: August 31, 2024
• Last Updated: September 20, 2024

Record last verified: 2024-09

Locations

CL (1)