Effectiveness of Dance on Patients With Fibromyalgia

This study has been completed.
Sponsor:
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00961805
First received: April 30, 2009
Last updated: August 19, 2009
Last verified: August 2009
Results First Received: April 30, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Fibromyalgia
Interventions: Behavioral: Dance
Other: Control Group

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The recruitment of patients started in August 2007 and finished in April 2008. The recruitment was made in Sao Paulo Hospital division of Rheumatology

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Control Group 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).
Dance Group The participants in the dance group took one-hour 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.

Participant Flow:   Overall Study
    Control Group     Dance Group  
STARTED     40     40  
COMPLETED     40     40  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Group Control The waiting list
Dance Group The participants in the dance group took one-hour 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
Total Total of all reporting groups

Baseline Measures
    Group Control     Dance Group     Total  
Number of Participants  
[units: participants]
  40     40     80  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     40     40     80  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  49.1  ± 11.5     49.5  ± 10.9     49.3  ± 11.2  
Gender  
[units: participants]
     
Female     40     40     80  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
Brazil     40     40     80  



  Outcome Measures
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1.  Primary:   Visual Analog Scale for Pain   [ Time Frame: baseline, after 16 weeks and after 32 weeks ]

2.  Secondary:   Function - 6 Minute Walk Test   [ Time Frame: baseline, after 16 weeks and after 32 weeks ]

3.  Secondary:   Quality of Life - Fibromyalgia Impact Questionnaire   [ Time Frame: baseline, after 16 weeks and after 32 weeks ]

4.  Secondary:   Quality of Life - SF-36 -Functional Capacity   [ Time Frame: baseline, after 16 weeks and after 32 weeks ]

5.  Secondary:   Quality of Life - SF-36 - Physical Limitation   [ Time Frame: baseline, after 16 weeks and after 32 weeks ]

6.  Secondary:   Quality of Life - Sf-36 - Pain   [ Time Frame: baseline, after 16 weeks and after 32 weeks ]

7.  Secondary:   Quality of Life - Sf-36 - General Health State   [ Time Frame: baseline, after 16 weeks and after 32 weeks ]

8.  Secondary:   Quality of Life - SF-36 - Vitality   [ Time Frame: baseline, after 16 weeks and after 32 weeks ]

9.  Secondary:   Quality of Life - SF-36 - Social Aspects   [ Time Frame: baseline, after 16 weeks and after 32 weeks ]

10.  Secondary:   Quality of Life - SF-36 - Emotional Aspects   [ Time Frame: baseline, after 16 weeks and after 32 weeks ]

11.  Secondary:   Quality of Life - SF-36 - Mental Health   [ Time Frame: baseline, after 16 weeks and after 32 weeks ]

12.  Secondary:   Depression - Beck Inventory   [ Time Frame: Baseline, after 16 weeks and after 32 weeks ]

13.  Secondary:   Self-image - Body Dysmorphic Disorder Examination Questionnaire   [ Time Frame: Baseline, after 16 weeks and after 32 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Andreia S Baptista, PT
Organization: Federal University of Sao Paulo
phone: 551155764239
e-mail: deiasalvador1@yahoo.com.br


No publications provided by Federal University of São Paulo

Publications automatically indexed to this study:

Responsible Party: Andreia Salvador Baptista, Federal Unversity of Sao Paulo
ClinicalTrials.gov Identifier: NCT00961805     History of Changes
Other Study ID Numbers: 1044/06
Study First Received: April 30, 2009
Results First Received: April 30, 2009
Last Updated: August 19, 2009
Health Authority: Brazil: National Committee of Ethics in Research