Effectivity of virtual reality physical exercise program in brain and motor aging in fibromyalgia
| ISRCTN | ISRCTN65034180 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65034180 |
| Protocol serial number | DEP2015-70356-R |
| Sponsor | University of Extremadura |
| Funders | Ministerio de Economía y Competitividad, Government of Extremadura |
- Submission date
- 22/11/2017
- Registration date
- 07/12/2017
- Last edited
- 18/01/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Physical activity can help cope with brain and motor aging, both in healthy people and those with pathologies. This is the case of people with fibromyalgia, characterized by chronic pain, which because of the impact that the disease has on the physical, cognitive and cerebral functions, are a good study model. The effects of a physical activity program on cerebral, electrical and volumetric brain function, such as the pineal gland, in this population and its relation to well-being, sleep, heart rate variability and cognition, are unknown. Taking advantage of the development of new technologies, the use of video games to implement physical activity programs could offer us the advantage of working both physical and cognitive aspects, creating tasks where these two aspects occur simultaneously (dual tasks), resembling more to the conditions that we find in our day to day. The aim of this study is to develop and verify the effectiveness of a physical activity program based on virtual reality (VirtualEx-FM) on cognitive, cerebral, motor and cardiac function, as well as to study the relationships and mechanisms between cerebral aging In daily tasks related to quality of life in people with fibromyalgia.
Who can participate?
Women aged between 30 and 75 years old who have fibromyalgia
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive the standard level of care. Those in the second group receive six months of twice weekly virtual reality physical activity. Participants are assessed before and after for their symptoms of fibromyalgia and effectiveness of the physical activity programme.
What are the possible benefits and risks of participating?
Participants may benefit from improvements in their symptoms. There are no risks associated with participation.
Where is the study run from?
University of Extremadura (Spain)
When is the study starting and how long is it expected to run for?
July 2017 to June 2018
Who is funding the study?
1. Ministry of Economy and Competitiveness, MINECO (Spain)
2. Government of Extremadura (Spain)
Who is the main contact?
Dr Narcis Gusi
ngusi@unex.es
Contact information
Scientific
Av. Universidad s/n
Cáceres
10003
Spain
| 0000-0002-1001-8883 | |
| Phone | +34 (0)927 25 74 60 |
| ngusi@unex.es |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Blind randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Cost-effectiveness of a virtual reality physical exercise program in brain and motor aging in fibromyalgia |
| Study objectives | 1.Expermiental group will improve the quality of life and impact of fibromyalgia 2. Physical fitness tests, body composition and daily life activities will enhance with the intervention program 3. Brain dynamics and structures will be remodeled with the intervention 4. Cognitive impairments, psychophysiological response to daily life activities autonomic function, cortisol and melatonin samples will improve with the exercise program 5. Impact of pain, depression and quality sleep index will enhance with the intervention 6. Fear of falling and kinesiophobia will be reduced after the intervention program |
| Ethics approval(s) | Bioethics and biosafety committee of the University of Extremadura, 07/07/2017, ref: 62/2017 |
| Health condition(s) or problem(s) studied | Fibromyalgia |
| Intervention | Participants are randomly allocated to one of two groups. Those in the first group are the control group. Those in the second group perform physical activity within the VirtualEx-FM program. The program consists of two weekly 1-hour sessions for 24 weeks. It will be based on a Motion-Controlled Video Game on Microsoft Xbox Kinect and it will be carried out indoors in a room of the local fibromyalgia association's building. Participants are evaluated before and after the program in a non-invasive way: 1. Sociodemography, quality of life, life habits and impact of fibromyalgia 2. Brain aspects - magnetic resonance without contrast, cognitive, mental and cardiac (heart rate variability) 3. Electroencephalographic pattern and motor in daily activities by means of standardized tests of physical condition |
| Intervention type | Mixed |
| Primary outcome measure(s) |
1. Health related quality of life is measured using EQ-5D-5L and Whoqol – Brief questionnaires at baseline and 24 weeks |
| Key secondary outcome measure(s) |
1. Cognitive impairment is measured using the Mini-Mental State Examination (MMSE) and executive function with the Stroop test at baseline and 24 weeks |
| Completion date | 29/06/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Female |
| Target sample size at registration | 52 |
| Total final enrolment | 55 |
| Key inclusion criteria | 1. Women 2. Aged between 30 and 75 years 3. Diagnosed with fibromyalgia by a rheumatologist 4. Able to communicate effectively with the study staff 5. Read and signed the written informed consent |
| Key exclusion criteria | 1. Pregnancy 2. Changes in usual care therapies during the 8 weeks of treatment 3. Contraindications for physical exercise |
| Date of first enrolment | 18/12/2017 |
| Date of final enrolment | 31/12/2017 |
Locations
Countries of recruitment
- Spain
Study participating centre
Cáceres
10004
Spain
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Narcis Gusi (ngusi@unex.es). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 24/12/2019 | 18/01/2023 | Yes | No | |
| Results article | 11/07/2019 | 18/01/2023 | Yes | No | |
| Results article | 30/07/2020 | 18/01/2023 | Yes | No | |
| Results article | 20/03/2020 | 18/01/2023 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
18/01/2023: Publication references and total final enrolment added.
07/12/2017: Internal review.