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Effectiveness of Dance on Patients With Fibromyalgia

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00961805

First Posted: August 19, 2009

Last Update Posted: August 25, 2009

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

Federal University of São Paulo

Purpose

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.

Condition	Intervention
Fibromyalgia	Behavioral: Dance Other: Control Group


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Effectiveness of Dance on Patients With Fibromyalgia

Resource links provided by NLM:

MedlinePlus related topics: Fibromyalgia

U.S. FDA Resources

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:

Visual Analog Scale for Pain [ Time Frame: baseline, after 16 weeks and after 32 weeks ]

Secondary Outcome Measures:

Function - 6 Minute Walk Test [ Time Frame: baseline, after 16 weeks and after 32 weeks ]
Quality of Life - Fibromyalgia Impact Questionnaire [ Time Frame: 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 ]
Quality of Life - SF-36 - Physical Limitation [ Time Frame: baseline, after 16 weeks and after 32 weeks ]
Quality of Life - Sf-36 - Pain [ Time Frame: 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 ]
Quality of Life - SF-36 - Vitality [ Time Frame: 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 ]
Quality of Life - SF-36 - Emotional Aspects [ Time Frame: 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 ]
Depression - Beck Inventory [ Time Frame: 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 ]


Enrollment:	80
Study Start Date:	August 2007
Study Completion Date:	November 2008
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Dance Group Belly dance	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.
No Intervention: Control Group Waiting list	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).

Arms

Assigned Interventions

Experimental: Dance Group

Belly dance

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.

No Intervention: Control Group

Waiting list

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).

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00961805

Locations


Brazil
Federal University of Sao Paulo
Sao Paulo, SP, Brazil, 04023-090

Sponsors and Collaborators

Federal University of São Paulo

Investigators


Principal Investigator:	Andreia S Baptista, PT	Federal University of Sao Paulo
Study Chair:	Jamil Natour, MD	Federal University of Sao Paulo

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Andreia Salvador Baptista, Federal Unversity of Sao Paulo
ClinicalTrials.gov Identifier:	NCT00961805 History of Changes
Other Study ID Numbers:	1044/06
First Submitted:	April 30, 2009
First Posted:	August 19, 2009
Results First Submitted:	April 30, 2009
Results First Posted:	August 19, 2009
Last Update Posted:	August 25, 2009
Last Verified:	August 2009

Keywords provided by Federal University of São Paulo:


Fibromyalgia Treatment Dance Randomized controlled study Exercise

Additional relevant MeSH terms:


Fibromyalgia Myofascial Pain Syndromes Muscular Diseases Musculoskeletal Diseases	Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases

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