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Trial registered on ANZCTR


Registration number
ACTRN12615000836538
Ethics application status
Approved
Date submitted
2/07/2015
Date registered
11/08/2015
Date last updated
11/08/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of a Virtual Reality-based physical exercise in fibromyalgia patients. A randomized controlled trial.
Scientific title
Effects of a Virtual Reality-based physical exercise on health-related quality of life, pain, activities of daily living, physical fitness, and wellbeing in fibromyalgia patients. A randomized controlled trial.
Secondary ID [1] 287012 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fibromyalgia 295478 0
Condition category
Condition code
Physical Medicine / Rehabilitation 295732 295732 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The program will consist on two weekly 1-hour sessions for 8 weeks. It will be based on a Motion-Controlled Video Game on Microsoft Xbox Kinect ,and it will be carried out indoor, in a room of the local fibromyalgia association´s building.

The Virtual Reality program comprises different activities:
1) Warm-up tasks based on joint movement.
2) Aerobic dance tasks at adjustable intensity.
3) Gait tasks. Participants have to walk on a footprints circuit.
4) Postural tasks focused on static and dynamic balance control.

Sessions will be performed in groups of three women. A technician will conduct and supervise all sessions. This technician will register the attendance.
Intervention code [1] 292220 0
Rehabilitation
Intervention code [2] 292382 0
Lifestyle
Intervention code [3] 292383 0
Treatment: Other
Comparator / control treatment
The control group will continue their usual daily activities during the 8-week study period.
Control group
Active

Outcomes
Primary outcome [1] 295446 0
Composite primary outcome: Health-related quality of life and impact of fibromyalgia. Three well-known generic Health-related quality of life questionnaires will be utilized: EQ-5D-5L, AQoL, and 15D. Impact of fibromyalgia (sometimes known as specific health-related quality of life) will be assessed using the Fibromyalgia Impact Questionnaire (FIQ) and its revised version, the FIQ-R.
Timepoint [1] 295446 0
At baseline and after 8-week treatment
Primary outcome [2] 295447 0
bodily pain. It will be assessed using a Visual Analog Scale (VAS) and with an algometer on the fibromyalgia-specific tender points.
Timepoint [2] 295447 0
At baseline and after 8-week treatment.
Before and after each session.
Primary outcome [3] 295448 0
Composite primary outcome: Activities of daily living and physical fitness. The following fitness outcomes will be measured:
a) Dynamic balance using Timed-up and go
b) Lower limb strength using 30s chair stand test and the 10-step stair climbing test with and without carrying a load.
c) Hand-grip strength using a grip-strength dynamometer (TKK 5401 Model).
d) Aerobic endurance using the Six Minutes Walk Test.
e) Upper body strength using the “Arm Curl Test”.
f) Velocity: The time needed to walk 20m will be recorded.
g) Balance using Biodex Balance System. This device measures, in degrees, the tilt about each axis during static and dynamic conditions and calculates a mediolateral stability index, an anteroposterior stability index, and an overall stability index.

All tests will be performed with a wireless motion capture device "Functional Assessment of Biomechanics (FAB)" in order to assess the motor pattern of the activities of daily living.
Timepoint [3] 295448 0
At baseline and after 8-week treatment
Secondary outcome [1] 315598 0
Wellbeing: assessed using the General Happiness Scale and the Satisfaction with Life Scale (SWLS).
Timepoint [1] 315598 0
At baseline and after 8-week treatment
Secondary outcome [2] 315599 0
Depression will be assessed using the Geriatric Depression Scale (GDS)
Timepoint [2] 315599 0
At baseline and after 8-week treatment
Secondary outcome [3] 315601 0
Body Composition using a bioelectrical impedance analysis (Tanita BC-418). This device measures weight, body mass index, fat mass, muscle mass, total body water, and free fat mass. The waist-to-hip ratio will also be assessed.
Timepoint [3] 315601 0
At baseline and after 8-week treatment
Secondary outcome [4] 315602 0
Perceived effort using a Borg scale from 1 to 10
Timepoint [4] 315602 0
After each session
Secondary outcome [5] 316029 0
Sociodemographic variables: gender, age, education level, profession, income level, religiosity, postal code and familiar situation.
Timepoint [5] 316029 0
At baseline
Secondary outcome [6] 316030 0
Drug treatment: The drugs that they are taking will be asked to the participants. In addition, participants will be asked for another kind of therapies.
Timepoint [6] 316030 0
At baseline and after 8-week treatment
Secondary outcome [7] 316031 0
Number of visits to the health care system in the last month will be asked in order to perform cost-effectiveness analysis.
Timepoint [7] 316031 0
At baseline and after 8-week treatment
Secondary outcome [8] 316032 0
Self-reported work absence: It will be assessed by a single question asking the number of days that participants had to miss work in the last month.
Timepoint [8] 316032 0
At baseline and after 8-week treatment
Secondary outcome [9] 316034 0
Fear of falling will be assessed with a VAS from 0 (no fear) to 100 (extreme fear)
Timepoint [9] 316034 0
At baseline and after 8-week treatment
Secondary outcome [10] 316235 0
Self-reported number of falls in the last year and in the last 2 months will be asked.
Timepoint [10] 316235 0
At baseline and after 8-week treatment

Eligibility
Key inclusion criteria
a) Be a woman
b) Be aged between 30 and 75 years
c) Be diagnosed with fibromyalgia by a rheumatologist
d) be able to communicate effectively with the study staff
e) Have read and sign the written informed consent
Minimum age
30 Years
Maximum age
75 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
a) be pregnant
b) change their usual care therapies during the 8 weeks of treatment
c) have contraindications for physical exercise

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed. All participants will be recruited from a local fibromyalgia association. One of the researchers will determine if a subject is elegible for inclusion and will randomly allocate the participants to one of the two groups. This researcher will be aware of the decission but will not take part in the acquisition or statistical analysis of data.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization and allocation processes will be performed by one of the researchers using random code numbers. Each participant will be assigned a number in the order of their arrival. After that, 31 random numbers from 0 to 62 will be generated using the website: http://randomnumbergenerator.intemodino.com/es/generador-de-numeros-aleatorios.html. The 31 participants with the generated numbers will be assigned to the intervention group, and the other 31 will be assigned to the control group. In order to preserve the double blind factor, this researcher will not take part in the acquisition or statistical analysis of data.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size was calculated for the FIQ score. A Minimal clinically important difference in the FIQ is a reduction of 14% in the total FIQ score. Assuming an unilateral alternative, we can detect differences of at least 14% with a power of 85% and a of 0.05 with two groups of 26 participants, with a mean in the FIQ of 70.5 and a standard deviation of 11.8 points. Assuming a maximum loss of follow-up of 20%, we will recruit 31 participants with fibromyalgia for each group.

The statistical analysis will be developed for two types of groups: a) intention to treat, with all patients randomised; and b) protocol evaluation, with patients who follow all the instructions and complete the treatment.

Both groups will be compared at baseline. Continuous variables will be analysed with one-way analysis of variance or the non-parametric method of Kruskall-Wallis, and Chi-square tests.

Training effects on the outcome variables will be assessed using the ANOVA of repeated measures.

For each outcome variable, the effect size and the level of significance corresponding to the main group (among-subjects), time (within-subjects) and interaction (group × time) effects will be reported.

Cost-effectiveness and cost-utility analyses will be performed, taking into account the socio-demographic variables cited above. Cost-effectiveness will be compared between the intervention and the control group. Direct medical costs, visits to the health care center, and work absence costs will be estimated based on Spanish data. Cost-utility analyses will be performed through the single utility score of generic HRQoL questionnaires like 15D or EQ-5D-5L

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/09/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
62
Accrual to date
Final
Recruitment outside Australia
Country [1] 7010 0
Spain
State/province [1] 7010 0
Palencia

Funding & Sponsors
Funding source category [1] 291565 0
Government body
Name [1] 291565 0
Spanish Ministry of Economy and Competitiveness
Country [1] 291565 0
Spain
Funding source category [2] 291566 0
Government body
Name [2] 291566 0
Government of Extremadura
Country [2] 291566 0
Spain
Funding source category [3] 291567 0
Charities/Societies/Foundations
Name [3] 291567 0
Fundacion Tatiana Perez de Guzman el Bueno
Country [3] 291567 0
Spain
Primary sponsor type
Individual
Name
Narcis Gusi Fuertes
Address
Faculty of Sport Science (University of Extremadura).
Avda. Universidad s/n 10003 Caceres (Spain)
Country
Spain
Secondary sponsor category [1] 290241 0
None
Name [1] 290241 0
Address [1] 290241 0
Country [1] 290241 0
Other collaborator category [1] 278507 0
Individual
Name [1] 278507 0
Daniel Collado Mateo
Address [1] 278507 0
Faculty of Sport Science (University of Extremadura).
Avda. Universidad s/n 10003 Caceres (Spain)
Country [1] 278507 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293106 0
Comision de Bioetica y de Bioseguridad de la Universidad de Extremadura (Committee of bioethics and biosecurity of the University of Extremadura)
Ethics committee address [1] 293106 0
Ethics committee country [1] 293106 0
Spain
Date submitted for ethics approval [1] 293106 0
07/04/2015
Approval date [1] 293106 0
26/05/2015
Ethics approval number [1] 293106 0
61/2015

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58490 0
Prof Narcis Gusi Fuertes
Address 58490 0
Fitness and Quality of Life Lab. (AFYCAV) Faculty of Sport Sciences University of Extremadura Avda. de la universidad s/n - 10003 Caceres
Country 58490 0
Spain
Phone 58490 0
+34 927 257460
Fax 58490 0
Email 58490 0
ngusi@unex.es
Contact person for public queries
Name 58491 0
Narcis Gusi Fuertes
Address 58491 0
Fitness and Quality of Life Lab. (AFYCAV) Faculty of Sport Sciences University of Extremadura Avda. de la universidad s/n - 10003 Caceres
Country 58491 0
Spain
Phone 58491 0
+34 927 257460
Fax 58491 0
Email 58491 0
ngusi@unex.es
Contact person for scientific queries
Name 58492 0
Narcis Gusi Fuertes
Address 58492 0
Fitness and Quality of Life Lab. (AFYCAV) Faculty of Sport Sciences University of Extremadura Avda. de la universidad s/n - 10003 Caceres
Country 58492 0
Spain
Phone 58492 0
+34 927 257460
Fax 58492 0
Email 58492 0
ngusi@unex.es

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffects of Exergames on Quality of Life, Pain, and Disease Effect in Women With Fibromyalgia: A Randomized Controlled Trial.2017https://dx.doi.org/10.1016/j.apmr.2017.02.011
EmbaseExergames for women with fibromyalgia: A randomised controlled trial to evaluate the effects on mobility skills, balance and fear of falling.2017https://dx.doi.org/10.7717/peerj.3211
N.B. These documents automatically identified may not have been verified by the study sponsor.