Fibromyalgia (FM)NCT06606132
Effects of Immersive Virtual Reality on Quality of Life, Stress, Anxiety, Depression and Grip Strength in Fibromyalgia: A Pilot Study
A study testing Exercise in people with Fibromyalgia (FM), run by Universidad San Sebastián at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia (FM)
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChile
- Study dates
- 1 Jun 2023to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Males and females; over 18 years of age; with a diagnosis of fibromyalgia issued by a medical professional under the ACR criteria (2016)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Fibromyalgia (FM) is a chronic rheumatic disorder characterized by widespread musculoskeletal pain, mood problems, and cognitive impairment with a worldwide prevalence ranging from 2 to 4%, affecting mainly women in a 9:1 ratio and with the age of most significant impact between 25 and 50 years. Patients with FM have an impaired quality of life and frequently seek medical attention, which is reflected in significant healthcare costs. It is estimated that the annual number of medical consultations for FM is almost double that of healthy individuals. Although the exact etiology is not yet fully understood, it has been described that people have a genetic predisposition that, together with physical and emotional factors, including the chronicity of a neuromusculoskeletal injury, can trigger it.
The diverse symptomatology of FM makes it challenging to diagnose. Patients often report a feeling of muscle weakness and fatigue, which can diminish their ability to maintain adequate strength for daily tasks. The altered pain perception that characterizes FM can make even simple tasks such as gripping difficult, as pain and discomfort tend to intensify with repetitive or prolonged use of the hand and forearm muscles. Several studies have reported a generalized decrease in muscle strength, noting that this decrease is inversely related to symptom severity. Psychologically, people with FM are characterized by the presence of negative emotions associated with a state of generalized distress. This state of psychological distress can be accompanied by cognitive and emotional disturbances that can considerably affect the quality of life of patients and even the severity of the syndrome. Constant preoccupation with pain management and uncertainty about the future are both associated with additional symptoms, such as difficulty sleeping and fatigue. The above creates a vicious circle in which stress contributes to physical discomfort, and physical discomfort favors stress. In this context, several authors suggest that there may be reduced levels of resilience and effective coping strategies that may generate low self-efficacy and inefficient modulation of nociceptive stimuli, leading to a bidirectional relationship between the presence of pain and psychoemotional symptoms. On the other hand, these psycho-cognitive mechanisms may be influenced by nociplastic and inflammatory alterations, which would contribute to a reciprocal etiopathogenesis between central and peripheral mechanisms, making treatment more difficult.
The 2017 European guideline recommendations for FM propose a multimodal therapeutic approach that can be tailored to the individual patient\'s characteristics and contributes to reducing symptom severity and improving quality of life, allowing the person to learn to live as well as possible with their disease. This approach starts with non-pharmacological measures such as health education, physical therapy, and psychotherapy, followed by pharmacological measures such as using pain modulators like duloxetine or pregabalin and medications for sleep disorders. Different studies propose that these approaches can be used simultaneously and that other complementary strategies that could improve the patient\'s therapeutic experience should also be considered.
Virtual reality (VR) systems have proven to be a complementary therapeutic option with beneficial effects for treating various health conditions. One of the modalities that present a relevant multisensory experience corresponds to immersive virtual reality-based exercise (iVRE), which, given the high level of immersion provided by VR, offers a unique experience, becoming a promising tool in the active treatment of FM. Patients enter a controlled virtual environment that can complement or improve conventional treatment. Current evidence describes the efficacy of VR in chronic pain syndromes and central neurological injuries, incorporating relaxation exercises, cognitive therapies, and adapted physical activities. This interaction may improve cognitive function and reduce symptoms of anxiety and depression associated with their health condition.
Although there is a growing body of knowledge associated with favorable experiences in using VR in FM, it is incipient concerning the immersive modality, particularly when coupled with exercise . In fact, a recent systematic review suggests new studies that include the benefits of this intervention on physical capacity, quality of life, and psychoemotional variables in FM. Therefore, this study aims to evaluate the effect of an iVRE program on the impact of FM on quality of life, stress, anxiety, depression, and handgrip strength in people with FM.
A single-arm, pre-post-test pilot study was designed. The study was conducted at the Universidad San Sebastián, Bio Bío, Chile, and originated from a collaborative project of Community Engagement ('Vinculación con el Medio') of the same University. The study sample was recruited by convenience after applying the following criteria: i) Inclusion: Adults over 18 years of age diagnosed with FM. This diagnosis was previously made by a medical professional under the updated FM diagnostic criteria; ii) Exclusion: Women in a state of pregnancy or breastfeeding, oncological pain, uncontrolled metabolic disorder, vertigo or similar condition, or any physical or cognitive impairment that would hinder communication with the investigators and the ability to perform the intervention protocols.
The clinical investigators performed a complete anamnesis and completed a structured clinical form to collect sociodemographic, health, and pharmacological treatment data. The Scientific Ethical Committee of the Universidad San Sebastián approved this study (N° 151-23). It was conducted following the 1964 Declaration of Helsinki and its subsequent modifications. All patients signed an informed consent form prior to participation.
Intervention (iVRE)
The iVRE 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.
- Conditions
- Fibromyalgia (FM)
- Being tested
- Exercise
- Keywords
- fibromyalgia, virtual reality, exercise
- Medical subject headings
- Fibromyalgia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Also called virtual reality
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: six weeks
Secondary outcomes (2)
Stress, anxiety and depression
Stress, anxiety, and depression were assessed using the Depression Anxiety Stress Scale-21 (DASS-21). This self-administered dimensional test consists of twenty-one questions to evaluate three categories, specifically stress, anxiety, and depression. It presents four response options for each category, evaluated on a scale from 0 to 3. The score obtained for each category is multiplied by 2, and the result is classified as normal, mild, moderate, severe, and extremely severe
Measured: six weeks
Handgrip strength
The handgrip strength was measured with a Baseline hydraulic dynamometer (Fabrication Enterprises Inc., White Plains, NY). The dominant side was evaluated, and the average of three measurements in kilograms was obtained. The position of each measurement was performed with the subject seated, elbow flexed at 90°, wrist in neutral position, and the subject was instructed to squeeze the instrument as hard as possible.
Measured: six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2024
- Study start1 Jun 2023
- Primary completion31 Dec 2023
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibromyalgia (FM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single-arm, pre-post-test pilot study was designed
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad San Sebastián
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, gonzalo arias alvarez, Universidad San Sebastián
- Investigators
- GONZALO j ARIAS ALVAREZ, Master, Principal investigator, Universidad San Sebastián
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06606132
- Sponsor's protocol ID
- 2
- Status last verified
- Sep 2024
- First submitted
- 18 Sep 2024
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: WE DIDN\'T HAVE IT CONSIDERED, BUT WE DON\'T RULE OUT IT IN THE FUTURE.
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Immersive Virtual Reality on Quality of Life, Stress, Anxiety, Depression and Grip Strength in Fibromyalgia: A Pilot Study
- ClinicalTrials.gov ID
- NCT06606132
- Acronym / sponsor ID
- 2
- Conditions
- Fibromyalgia (FM)
- Keywords
- fibromyalgia, virtual reality, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universidad San SebastiánUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 20 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Fibromyalgia (FM) is a chronic rheumatic disorder characterized by widespread musculoskeletal pain, mood problems, and cognitive impairment with a worldwide prevalence ranging from 2 to 4%, affecting mainly women in a 9:1 ratio and with the age of most significant impact between 25 and 50 years. Patients with FM have an impaired quality of life and frequently seek medical attention, which is reflected in significant healthcare costs. It is estimated that the annual number of medical consultations for FM is almost double that of healthy individuals. Although the exact etiology is not yet fully understood, it has been described that people have a genetic predisposition that, together with physical and emotional factors, including the chronicity of a neuromusculoskeletal injury, can trigger it.
The diverse symptomatology of FM makes it challenging to diagnose. Patients often report a feeling of muscle weakness and fatigue, which can diminish their ability to maintain adequate strength for daily tasks. The altered pain perception that characterizes FM can make even simple tasks such as gripping difficult, as pain and discomfort tend to intensify with repetitive or prolonged use of the hand and forearm muscles. Several studies have reported a generalized decrease in muscle strength, noting that this decrease is inversely related to symptom severity. Psychologically, people with FM are characterized by the presence of negative emotions associated with a state of generalized distress. This state of psychological distress can be accompanied by cognitive and emotional disturbances that can considerably affect the quality of life of patients and even the severity of the syndrome. Constant preoccupation with pain management and uncertainty about the future are both associated with additional symptoms, such as difficulty sleeping and fatigue. The above creates a vicious circle in which stress contributes to physical discomfort, and physical discomfort favors stress. In this context, several authors suggest that there may be reduced levels of resilience and effective coping strategies that may generate low self-efficacy and inefficient modulation of nociceptive stimuli, leading to a bidirectional relationship between the presence of pain and psychoemotional symptoms. On the other hand, these psycho-cognitive mechanisms may be influenced by nociplastic and inflammatory alterations, which would contribute to a reciprocal etiopathogenesis between central and peripheral mechanisms, making treatment more difficult.
The 2017 European guideline recommendations for FM propose a multimodal therapeutic approach that can be tailored to the individual patient\'s characteristics and contributes to reducing symptom severity and improving quality of life, allowing the person to learn to live as well as possible with their disease. This approach starts with non-pharmacological measures such as health education, physical therapy, and psychotherapy, followed by pharmacological measures such as using pain modulators like duloxetine or pregabalin and medications for sleep disorders. Different studies propose that these approaches can be used simultaneously and that other complementary strategies that could improve the patient\'s therapeutic experience should also be considered.
Virtual reality (VR) systems have proven to be a complementary therapeutic option with beneficial effects for treating various health conditions. One of the modalities that present a relevant multisensory experience corresponds to immersive virtual reality-based exercise (iVRE), which, given the high level of immersion provided by VR, offers a unique experience, becoming a promising tool in the active treatment of FM. Patients enter a controlled virtual environment that can complement or improve conventional treatment. Current evidence describes the efficacy of VR in chronic pain syndromes and central neurological injuries, incorporating relaxation exercises, cognitive therapies, and adapted physical activities. This interaction may improve cognitive function and reduce symptoms of anxiety and depression associated with their health condition.
Although there is a growing body of knowledge associated with favorable experiences in using VR in FM, it is incipient concerning the immersive modality, particularly when coupled with exercise . In fact, a recent systematic review suggests new studies that include the benefits of this intervention on physical capacity, quality of life, and psychoemotional variables in FM. Therefore, this study aims to evaluate the effect of an iVRE program on the impact of FM on quality of life, stress, anxiety, depression, and handgrip strength in people with FM.
A single-arm, pre-post-test pilot study was designed. The study was conducted at the Universidad San Sebastián, Bio Bío, Chile, and originated from a collaborative project of Community Engagement ('Vinculación con el Medio') of the same University. The study sample was recruited by convenience after applying the following criteria: i) Inclusion: Adults over 18 years of age diagnosed with FM. This diagnosis was previously made by a medical professional under the updated FM diagnostic criteria; ii) Exclusion: Women in a state of pregnancy or breastfeeding, oncological pain, uncontrolled metabolic disorder, vertigo or similar condition, or any physical or cognitive impairment that would hinder communication with the investigators and the ability to perform the intervention protocols.
The clinical investigators performed a complete anamnesis and completed a structured clinical form to collect sociodemographic, health, and pharmacological treatment data. The Scientific Ethical Committee of the Universidad San Sebastián approved this study (N° 151-23). It was conducted following the 1964 Declaration of Helsinki and its subsequent modifications. All patients signed an informed consent form prior to participation.
Intervention (iVRE)
The iVRE 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single-arm, pre-post-test pilot study was designed
| Arm | Type | Receives |
|---|---|---|
| Exercise with virtual reality | Experimental | Other: ExerciseThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Males and females; over 18 years of age; with a diagnosis of fibromyalgia issued by a medical professional under the ACR criteria (2016)
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseAlso: virtual realityThe 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 |
Primary outcome
Impact of Fibromyalgia on Quality of Life
Time frame: six weeks
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
2 secondary outcomes
Stress, anxiety and depression
Time frame: six weeks
Handgrip strength
Time frame: six weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
- Individual participant dataSharing planned: Undecided. WE DIDN\'T HAVE IT CONSIDERED, BUT WE DON\'T RULE OUT IT IN THE FUTURE.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GONZALO j ARIAS ALVAREZ, Master principal investigator
Universidad San Sebastián
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Fibromyalgia (FM), run by Universidad San Sebastián at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of Fibromyalgia on Quality of Life (time frame: six weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2024.