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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Fibromyalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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. 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.

Group Type EXPERIMENTAL

Low-impact aerobic exercise combined with music therapy

Intervention Type OTHER

Intervention consists in working the muscles which are mostly affected by fibromyalgia through group exercises, which are dynamic, smooth and aim functionality. Each session consists of 60 minutes with 3 parts: initial warming up time, main part through games, group dynamics and pure aerobic workout, and final cool down with stretching. 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. For this, they were shown a list of 100 music compositions from which participants choose a minimum of 20 preferences. All exercises are performed with proper postural control both dissociated and global and within a framework of therapeutic proprioceptive gymnastics.

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.

Group Type EXPERIMENTAL

Low-impact aerobic exercise

Intervention Type OTHER

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

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

Group Type ACTIVE_COMPARATOR

Control group

Intervention Type OTHER

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

Interventions

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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. Each session consists of 60 minutes with 3 parts: initial warming up time, main part through games, group dynamics and pure aerobic workout, and final cool down with stretching. 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. For this, they were shown a list of 100 music compositions from which participants choose a minimum of 20 preferences. All exercises are performed with proper postural control both dissociated and global and within a framework of therapeutic proprioceptive gymnastics.

Intervention Type OTHER

Low-impact aerobic exercise

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.

Intervention Type OTHER

Control group

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes