- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00961805
Effectiveness of Dance on Patients With Fibromyalgia
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
SP
-
Sao Paulo, SP, Brazil, 04023-090
- Federal University of São Paulo
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Dance Group
Belly dance
|
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.
|
|
No Intervention: Control Group
Waiting list
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale for Pain
Time Frame: baseline, after 16 weeks and after 32 weeks
|
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
Time Frame: baseline, after 16 weeks and after 32 weeks
|
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
Time Frame: baseline, after 16 weeks and after 32 weeks
|
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
Time Frame: baseline, after 16 weeks and after 32 weeks
|
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
Time Frame: baseline, after 16 weeks and after 32 weeks
|
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
Time Frame: baseline, after 16 weeks and after 32 weeks
|
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
Time Frame: baseline, after 16 weeks and after 32 weeks
|
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
Time Frame: baseline, after 16 weeks and after 32 weeks
|
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
Time Frame: baseline, after 16 weeks and after 32 weeks
|
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
Time Frame: baseline, after 16 weeks and after 32 weeks
|
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
Time Frame: baseline, after 16 weeks and after 32 weeks
|
score between 0 from 100, with higher scores denoting better quality of life
|
baseline, after 16 weeks and after 32 weeks
|
|
Depression - Beck Inventory
Time Frame: Baseline, after 16 weeks and after 32 weeks
|
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
Time Frame: Baseline, after 16 weeks and after 32 weeks
|
scored between 0 from 168, with higher scores indicating greater level of dissatisfaction with self-image
|
Baseline, after 16 weeks and after 32 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Andreia S Baptista, PT, Federal University of São Paulo
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1044/06
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