Effect of Low-impact Aerobic Exercise and Music Therapy in Fibromyalgia (EffMusFibro)

University of Valencia

Status: Completed

Conditions: Fibromyalgia

Treatments: Other: Control group; Other: Low-impact aerobic exercise; Other: Low-impact aerobic exercise combined with music therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02516761

ID011

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 26 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• To be between 30 and 80 years old.

• Meet the new diagnostic criteria for fibromyalgia of the ACR..

• Meet some or several of the following characteristics:

  • Depression
  • Anxiety
  • Muscle pain
  • Fatigue
  • Sleep disturbance

• May have limited mobility as long as it is caused by fibromyalgia.

Exclusion criteria

• Medical contraindication for physical activity (locomotor disorder, uncontrolled cardiovascular disease, ...)
• Deafness or limited hearing
• Vestibular disorders that compromise balance.
• Very low visibility or blind people.
• Psychiatric disorders or excessive emotional tension that could alter the dynamics of the study (psychotic disorder)
• Cognitive disabilities
• Decompensation or changes in medication.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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26 participants in 3 patient groups

Low-impact aerobic exercise combined with music therapy

Experimental group

Description:

Intervention consists in working the muscles which are mostly affected by fibromyalgia through group exercises, which are dynamic, smooth and aim functionality. This exercise is done to the rhythm of melodic music, adapted to the tastes of the participants and also adapted on the way to perform the exercise.

Treatment:

Other: Low-impact aerobic exercise combined with music therapy

Low-impact aerobic exercise

Experimental group

Description:

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.

Treatment:

Other: Low-impact aerobic exercise

Control group

Active Comparator group

Description:

With this group no intervention is done, but they are assessed like the other groups.

Treatment:

Other: Control group