Fibromyalgia Clinical Trial
— EffMusFibroOfficial title:
Effect of Low-impact Aerobic Exercise Combined With Music Therapy in Patients With Fibromyalgia
Verified date | March 2016 |
Source | University of Valencia |
Contact | n/a |
Is FDA regulated | No |
Health authority | Spain: Ethics Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 26 |
Est. completion date | March 2016 |
Est. primary completion date | January 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 30 Years to 80 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Spain | Gemma V. Espí López | Valencia |
Lead Sponsor | Collaborator |
---|---|
University of Valencia |
Spain,
de Miquel CA, Campayo J, Flórez MT, Arguelles JM, Tarrio EB, Montoya MG, Martin Á, Salio AM, Fuentes JV, Alberch EA, de la Cámara AG. Interdisciplinary consensus document for the treatment of fibromyalgia. Actas Esp Psiquiatr. 2010 Mar-Apr;38(2):108-20. — View 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. Epub 2005 Sep 1. Review. — View Citation
Wolfe F, Walitt BT, Rasker JJ, Katz RS, Häuser 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes |
Secondary | Depression. | By Beck Depression Inventory. This scale aims to assess depression and its somatic intensity by 21 different items assessing depressive symptoms. It includes four answer options arranged from lowest to highest severity. This version is adapted to Spanish and validated and has an internal consistency with Cronbach's alpha coefficient = 0.83. The scale emphasizes more on the cognitive component of depression (15 items), being the symptoms of somatic / vegetative type the second most important group (6 items). The result of 0-9 points means that there is no depression, 10 to 18 points mild depression, 19-29 moderate depression and 30 points indicates severe depression. | 8 weeks | Yes |
Secondary | Impact on quality of life. | The Fibromyalgia Impact Questionnaire (FIQ).It is a multidimensional self-administered questionnaire with 10 items that evaluates the status of the patient the week before the test is filled, and it assesses the aspects that tend to be more affected in people with fibromyalgia. The first item contains 10 sub-items, ranging from 4 points (from = always to 3 = never) and assesses the patient's functional capacity in activities of daily living. The second and third item refers to days of the week and the rest are visual analog scales from 0 to 10. This scale was validated in its Spanish version in 2013, obtaining a Cronbach coefficient= 0.95. | 8 weeks | Yes |
Secondary | Balance. | Evaluated by the Berg Scale. Scale on which the balance is evaluated and consists of 14 items, which assess the change of position from sitting to standing position, as well as standing and sitting position without assistance, transfers, standing with eyes closed, feet together, one foot advanced, one leg support, inclination of the body, the ability to pick up an object from the floor and also to turn around (to look back only, or giving a full turn). The internal consistency of the questionnaire is alpha 0.98 and test-retest reliability of 0.98 with a range of 0.86 to 0.99 for individual items. | 8 weeks | Yes |
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