NCT02516761

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 4, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 6, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

March 24, 2016

Status Verified

March 1, 2016

Enrollment Period

6 months

First QC Date

August 4, 2015

Last Update Submit

March 22, 2016

Conditions

Fibromyalgia

Keywords

Fibromyalgia

Outcome Measures

Primary Outcomes (1)

  • General discomfort.

    General discomfort, using the Faces Pain Scale. This scale assesses in a global way widespread pain of patients. It values from 0 to 10 on a scale of facial expression (0 = no pain and smiling face, up to 10 = worst possible pain and sad face). The reliability coefficient for this scale is Cohen = 0.61.

    8 weeks

Secondary Outcomes (3)

  • Depression.

    8 weeks

  • Impact on quality of life.

    8 weeks

  • Balance.

    8 weeks

Study Arms (3)

Low-impact aerobic exercise combined with music therapy

EXPERIMENTAL

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.

Other: Low-impact aerobic exercise combined with music therapy

Low-impact aerobic exercise

EXPERIMENTAL

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.

Other: Low-impact aerobic exercise

Control group

ACTIVE COMPARATOR

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

Other: Control group

Interventions

Low-impact aerobic exercise combined with music therapyOTHER

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 combined with music therapy
Low-impact aerobic exerciseOTHER

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.

Low-impact aerobic exercise
Control groupOTHER

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

Control group

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gemma V. Espí López

Valencia, Valencia, 46010, Spain

Location

Related Publications (3)

  • 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.

    PMID: 26077414RESULT

  • 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.

    PMID: 16139959RESULT

  • 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.

    PMID: 21361054RESULT

MeSH Terms

Conditions

Fibromyalgia

Interventions

Music TherapyControl Groups

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and ActivitiesEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Gemma V gemma.espi@uv.es, P

    Department of Physiotherapy

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph, D

Study Record Dates

First Submitted

August 4, 2015

First Posted

August 6, 2015

Study Start

July 1, 2015

Primary Completion

January 1, 2016

Study Completion

March 1, 2016

Last Updated

March 24, 2016

Record last verified: 2016-03

Locations

ES(1)