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Trial from ANZCTR

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.

  • Recruitment status at the time of last update
    Not yet recruiting
  • What is the status of the ethics application?
    Ethics status: Approved
  • Prospective – trial registered prior to recruitment of first participant.

    Retrospective – trial registered after recruitment of first participant.
    Prospectively registered
  • Has the trial been updated in the last 12 months?
    Not up to date
    (Last updated: 11/8/2015)
  • Ethics status: Approved
    What is the status of the ethics application?
  • Not up to date
    Has the trial been updated in the last 6 months?
Key trial Information

Trial ID

ACTRN12615000836538

Date registered

11 August 2015

Health condition

Fibromyalgia

Recruitment countries

Spain

Recruitment status

Not yet recruiting

Anticipated date of first participant enrolment

07 September 2015

Ethics application status

Approved

Brief summary

Background: Fibromyalgia is a chronic disease characterized by widespread pain and several associated symptoms, which lead a reduction in health-related quality of life and activities of daily living. Virtual reality is a novel training alternative that has shown to be useful as a complementary treatment of different conditions.

Methods: A randomized controlled trial will be carried out. A number of 62 women with fibromyalgia will participate in the study. The virtual reality training program will consist on 2 weekly 1-hour sessions for 8 weeks. It will be based on Motion-Controlled Video Games and focused on the development of postural control, balance, endurance and strength. Effects on health-related quality of life, pain, physical fitness, activities of daily living, wellbeing, and depression will be assessed. Results will be compared with a control group that will continue with their daily life.

Discussion: To our knowledge, this is the first study that aims to evaluate the effects of a virtual reality-based physical exercise program in women suffering from fibromyalgia.

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

Gender

Females

Key exclusion criteria

a) be pregnant
b) change their usual care therapies during the 8 weeks of treatment
c) have contraindications for physical exercise

Contact details and further information

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

Contact person for information and recruitment

Prof Narcis Gusi Fuertes
Fitness and Quality of Life Lab. (AFYCAV) Faculty of Sport Sciences University of Extremadura Avda. de la universidad s/n - 10003 Caceres
Spain
+34 927 257460
ngusi@unex.es