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Effectiveness of Dance on Patients With Fibromyalgia

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ClinicalTrials.gov Identifier: NCT00961805
Recruitment Status : Completed
First Posted : August 19, 2009
Results First Posted : August 19, 2009
Last Update Posted : August 25, 2009
Sponsor:
Information provided by:
Federal University of São Paulo

Tracking Information
First Submitted Date  ICMJE April 30, 2009
First Posted Date  ICMJE August 19, 2009
Results First Submitted Date  ICMJE April 30, 2009
Results First Posted Date  ICMJE August 19, 2009
Last Update Posted Date August 25, 2009
Study Start Date  ICMJE August 2007
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 19, 2009)
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
Original Primary Outcome Measures  ICMJE
 (submitted: August 18, 2009)
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 unberable pain
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2009)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • Depression - Beck Inventory [ Time Frame: Baseline, after 16 weeks and after 32 weeks ]
    score between 0 from 63, with higher score indicating greater depression
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of Dance on Patients With Fibromyalgia
Official Title  ICMJE Effectiveness of Dance on Patients With Fibromyalgia
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Fibromyalgia
Intervention  ICMJE
  • Behavioral: 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.
  • Other: 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).
Study Arms  ICMJE
  • Experimental: Dance Group
    Belly dance
    Intervention: Behavioral: Dance
  • No Intervention: Control Group
    Waiting list
    Intervention: Other: Control Group
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 18, 2009)
80
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2008
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00961805
Other Study ID Numbers  ICMJE 1044/06
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Andreia Salvador Baptista, Federal Unversity of Sao Paulo
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Federal University of São Paulo
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andreia S Baptista, PT Federal University of Sao Paulo
Study Chair: Jamil Natour, MD Federal University of Sao Paulo
PRS Account Federal University of São Paulo
Verification Date August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP