Fibromyalgia Clinical Trial
Official title:
Effect of Low-impact Aerobic Exercise Combined With Music Therapy in Patients With Fibromyalgia
The idea of this study is the combination of these two techniques (low-impact aerobic exercise through functional movements and music therapy) that have proven to be effective separately. The main objective of this study is to test this combination to reduce widespread pain in fibromyalgia patients, improve their balance, influence on decreasing levels of depression and improve quality of life.
Material and methods Patients The sample includes volunteer subjects diagnosed with
fibromyalgia from the Valencian Association of People Affected by Fibromyalgia that were
submitted to participate in the study.
Study design It is a quasi-experimental, longitudinal, prospective, controlled, randomized,
single-blinded research. The sample was divided into 3 groups. Patients signed informed
consent and then the randomization of subjects to the different study groups was done
through computer software by an external assistant who was blinded to the study objectives.
The study was conducted in morning and afternoon sessions.
All those patients who belong to the experimental group 1 or 2 attend their sessions which
last 60 minutes and are held 2 times a week every other day. The experimental group 1
attends classes in the morning, while the experimental group 2 attends them in the evenings.
The control group only comes to the evaluation sessions without doing any particular
activity. The subjects are evaluated in two stages, at baseline and after completion of the
study.
Intervention Group 1 (G1): Low-impact aerobic exercise combined with music therapy.
Intervention consists in working the muscles which are mostly affected by fibromyalgia
through group exercises, which are dynamic, smooth and aim functionality.
Group 2 (G2): Low-impact aerobic exercise. Then intervention is like the previous group but
with the difference that physical activity is not performed to the rhythm of chosen melodic
music. Therefore, exercises are done with general chill-out music throughout the session,
without adaptation of the exercise to the music.
Control group (CG): With this group no intervention is done, but they are assessed like the
other groups.
Evaluation:
Depression, by Beck Depression Inventory, General discomfort, using the Faces Pain Scale,
Balance, evaluated by the Berg Scale.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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