Effectiveness of Dance on Patients With Fibromyalgia
Primary Purpose
Fibromyalgia
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Dance
Control Group
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia, Treatment, Dance, Randomized controlled study, Exercise
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
Sites / Locations
- Federal University of Sao Paulo
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Dance Group
Control Group
Arm Description
Belly dance
Waiting list
Outcomes
Primary Outcome Measures
Visual Analog Scale for Pain
score between 0 and 100 where 0 is no pain and 100 in unbearable pain
Secondary Outcome Measures
Function - 6 Minute Walk Test
meters traveled on a 20-meter course over a six-minute period
Quality of Life - Fibromyalgia Impact Questionnaire
score between 0 from 10 with 0 indicating no impairment and 10 indicating maximum impairment
Quality of Life - SF-36 -Functional Capacity
score between 0 from 100, with higher scores denoting better quality of life
Quality of Life - SF-36 - Physical Limitation
score between 0 from 100, with higher scores denoting better quality of life
Quality of Life - Sf-36 - Pain
score between 0 from 100, with higher scores denoting better quality of life
Quality of Life - Sf-36 - General Health State
score between 0 from 100, with higher scores denoting better quality of life
Quality of Life - SF-36 - Vitality
score between 0 from 100, with higher scores denoting better quality of life
Quality of Life - SF-36 - Social Aspects
score between 0 from 100, with higher scores denoting better quality of life
Quality of Life - SF-36 - Emotional Aspects
score between 0 from 100, with higher scores denoting better quality of life
Quality of Life - SF-36 - Mental Health
score between 0 from 100, with higher scores denoting better quality of life
Depression - Beck Inventory
score between 0 from 63, with higher score indicating greater depression
Self-image - Body Dysmorphic Disorder Examination Questionnaire
scored between 0 from 168, with higher scores indicating greater level of dissatisfaction with self-image
Full Information
NCT ID
NCT00961805
First Posted
April 30, 2009
Last Updated
August 19, 2009
Sponsor
Federal University of São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT00961805
Brief Title
Effectiveness of Dance on Patients With Fibromyalgia
Official Title
Effectiveness of Dance on Patients With Fibromyalgia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
November 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Federal University of São Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Fibromyalgia, Treatment, Dance, Randomized controlled study, Exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dance Group
Arm Type
Experimental
Arm Description
Belly dance
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Waiting list
Intervention Type
Behavioral
Intervention Name(s)
Dance
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control Group
Intervention Description
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).
Primary Outcome Measure Information:
Title
Visual Analog Scale for Pain
Description
score between 0 and 100 where 0 is no pain and 100 in unbearable pain
Time Frame
baseline, after 16 weeks and after 32 weeks
Secondary Outcome Measure Information:
Title
Function - 6 Minute Walk Test
Description
meters traveled on a 20-meter course over a six-minute period
Time Frame
baseline, after 16 weeks and after 32 weeks
Title
Quality of Life - Fibromyalgia Impact Questionnaire
Description
score between 0 from 10 with 0 indicating no impairment and 10 indicating maximum impairment
Time Frame
baseline, after 16 weeks and after 32 weeks
Title
Quality of Life - SF-36 -Functional Capacity
Description
score between 0 from 100, with higher scores denoting better quality of life
Time Frame
baseline, after 16 weeks and after 32 weeks
Title
Quality of Life - SF-36 - Physical Limitation
Description
score between 0 from 100, with higher scores denoting better quality of life
Time Frame
baseline, after 16 weeks and after 32 weeks
Title
Quality of Life - Sf-36 - Pain
Description
score between 0 from 100, with higher scores denoting better quality of life
Time Frame
baseline, after 16 weeks and after 32 weeks
Title
Quality of Life - Sf-36 - General Health State
Description
score between 0 from 100, with higher scores denoting better quality of life
Time Frame
baseline, after 16 weeks and after 32 weeks
Title
Quality of Life - SF-36 - Vitality
Description
score between 0 from 100, with higher scores denoting better quality of life
Time Frame
baseline, after 16 weeks and after 32 weeks
Title
Quality of Life - SF-36 - Social Aspects
Description
score between 0 from 100, with higher scores denoting better quality of life
Time Frame
baseline, after 16 weeks and after 32 weeks
Title
Quality of Life - SF-36 - Emotional Aspects
Description
score between 0 from 100, with higher scores denoting better quality of life
Time Frame
baseline, after 16 weeks and after 32 weeks
Title
Quality of Life - SF-36 - Mental Health
Description
score between 0 from 100, with higher scores denoting better quality of life
Time Frame
baseline, after 16 weeks and after 32 weeks
Title
Depression - Beck Inventory
Description
score between 0 from 63, with higher score indicating greater depression
Time Frame
Baseline, after 16 weeks and after 32 weeks
Title
Self-image - Body Dysmorphic Disorder Examination Questionnaire
Description
scored between 0 from 168, with higher scores indicating greater level of dissatisfaction with self-image
Time Frame
Baseline, after 16 weeks and after 32 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreia S Baptista, PT
Organizational Affiliation
Federal University of Sao Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jamil Natour, MD
Organizational Affiliation
Federal University of Sao Paulo
Official's Role
Study Chair
Facility Information:
Facility Name
Federal University of Sao Paulo
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04023-090
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
23020850
Citation
Baptista AS, Villela AL, Jones A, Natour J. Effectiveness of dance in patients with fibromyalgia: a randomized, single-blind, controlled study. Clin Exp Rheumatol. 2012 Nov-Dec;30(6 Suppl 74):18-23. Epub 2012 Dec 14.
Results Reference
derived
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Effectiveness of Dance on Patients With Fibromyalgia
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