Effectiveness of Dance on Patients With Fibromyalgia

Study Overview
=================
Brief Summary
-----------------
The aim of the present study is to assess the effectiveness of belly dance as a treatment for pain and improving the quality of life of patients with fibromyalgia. Eighty female patients with fibromyalgia between 18 to 65 years were randomly allocated to a dance group (n=40) and control group (n=40). Patients in the dance group underwent 16 weeks of belly dance twice a week, while the patients in the control group remained on a waiting list. Patients were evaluated with regard to pain (Visual Analogue Scale), function (6 minute walk test), quality of life (Fibromyalgia Impact Questionnaire and SF-36), depression (Beck Inventory), anxiety (State-Trait Anxiety Inventory) and self-image (Body Dysmorphic Disorder Examination) questionnaire. Evaluations were carried out at baseline, after 16 weeks and after 32 weeks.

Official Title
-----------------
Effectiveness of Dance on Patients With Fibromyalgia

Conditions
-----------------
Fibromyalgia

Intervention / Treatment
-----------------
* Behavioral: Dance
* Other: Control Group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: classification of fibromyalgia based on the criteria of the American College of Rheumatology female gender aged between 18 and 65 years Exclusion Criteria: not having altered treatment in previous three years having signed a term of informed consent patients with other rheumatic diseases, painful osteoarticular conditions, uncontrolled cardiopulmonary disease, diseases of the lower limbs or uncontrolled diabetes were excluded

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dance Group<br>Belly dance | Behavioral: Dance<br>* Belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.<br>|
| No Intervention: Control Group<br>Waiting list | Other: Control Group<br>* The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale for Pain | score between 0 and 100 where 0 is no pain and 100 in unbearable pain | baseline, after 16 weeks and after 32 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Function - 6 Minute Walk Test | meters traveled on a 20-meter course over a six-minute period | baseline, after 16 weeks and after 32 weeks | 
| Quality of Life - Fibromyalgia Impact Questionnaire | score between 0 from 10 with 0 indicating no impairment and 10 indicating maximum impairment | baseline, after 16 weeks and after 32 weeks | 
| Quality of Life - SF-36 -Functional Capacity | score between 0 from 100, with higher scores denoting better quality of life | baseline, after 16 weeks and after 32 weeks | 
| Quality of Life - SF-36 - Physical Limitation | score between 0 from 100, with higher scores denoting better quality of life | baseline, after 16 weeks and after 32 weeks | 
| Quality of Life - Sf-36 - Pain | score between 0 from 100, with higher scores denoting better quality of life | baseline, after 16 weeks and after 32 weeks | 
| Quality of Life - Sf-36 - General Health State | score between 0 from 100, with higher scores denoting better quality of life | baseline, after 16 weeks and after 32 weeks | 
| Quality of Life - SF-36 - Vitality | score between 0 from 100, with higher scores denoting better quality of life | baseline, after 16 weeks and after 32 weeks | 
| Quality of Life - SF-36 - Social Aspects | score between 0 from 100, with higher scores denoting better quality of life | baseline, after 16 weeks and after 32 weeks | 
| Quality of Life - SF-36 - Emotional Aspects | score between 0 from 100, with higher scores denoting better quality of life | baseline, after 16 weeks and after 32 weeks | 
| Quality of Life - SF-36 - Mental Health | score between 0 from 100, with higher scores denoting better quality of life | baseline, after 16 weeks and after 32 weeks | 
| Depression - Beck Inventory | score between 0 from 63, with higher score indicating greater depression | Baseline, after 16 weeks and after 32 weeks | 
| Self-image - Body Dysmorphic Disorder Examination Questionnaire | scored between 0 from 168, with higher scores indicating greater level of dissatisfaction with self-image | Baseline, after 16 weeks and after 32 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fibromyalgia, Treatment, Dance, Randomized controlled study, Exercise