Clinical trial NCT02516761: Effect of Low-impact Aerobic Exercise and Music Therapy in Fibromyalgia
Official title: Effect of Low-impact Aerobic Exercise Combined With Music Therapy in Patients With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2015-08-06
Enrollment: 26
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: General discomfort.
timeFrame: 8 weeks
Secondary outcomes:
measure: Depression.
timeFrame: 8 weeks
measure: Impact on quality of life.
timeFrame: 8 weeks
measure: Balance.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Gemma V. Espí López
Study officials:
affiliation: Department of Physiotherapy
name: Gemma V gemma.espi@uv.es, P
role: STUDY_DIRECTOR
References:
citation: Wolfe F, Walitt BT, Rasker JJ, Katz RS, Hauser W. The Use of Polysymptomatic Distress Categories in the Evaluation of Fibromyalgia (FM) and FM Severity. J Rheumatol. 2015 Aug;42(8):1494-501. doi: 10.3899/jrheum.141519. Epub 2015 Jun 15.
citation: Kajantie E, Phillips DI. The effects of sex and hormonal status on the physiological response to acute psychosocial stress. Psychoneuroendocrinology. 2006 Feb;31(2):151-78. doi: 10.1016/j.psyneuen.2005.07.002. Epub 2005 Sep 1.
citation: de Miquel CA, Campayo J, Florez MT, Arguelles JM, Tarrio EB, Montoya MG, Martin A, Salio AM, Fuentes JV, Alberch EA, de la Camara AG. Interdisciplinary consensus document for the treatment of fibromyalgia. Actas Esp Psiquiatr. 2010 Mar-Apr;38(2):108-20.