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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Dance on Patients With Fibromyalgia

Resource links provided by NLM:


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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Function - 6 Minute Walk Test [ Time Frame: baseline, after 16 weeks and after 32 weeks ] [ Designated as safety issue: Yes ]
  • Quality of Life - Fibromyalgia Impact Questionnaire [ Time Frame: baseline, after 16 weeks and after 32 weeks ] [ Designated as safety issue: Yes ]
  • Quality of Life - SF-36 -Functional Capacity [ Time Frame: baseline, after 16 weeks and after 32 weeks ] [ Designated as safety issue: Yes ]
  • Quality of Life - SF-36 - Physical Limitation [ Time Frame: baseline, after 16 weeks and after 32 weeks ] [ Designated as safety issue: Yes ]
  • Quality of Life - Sf-36 - Pain [ Time Frame: baseline, after 16 weeks and after 32 weeks ] [ Designated as safety issue: Yes ]
  • Quality of Life - Sf-36 - General Health State [ Time Frame: baseline, after 16 weeks and after 32 weeks ] [ Designated as safety issue: Yes ]
  • Quality of Life - SF-36 - Vitality [ Time Frame: baseline, after 16 weeks and after 32 weeks ] [ Designated as safety issue: Yes ]
  • Quality of Life - SF-36 - Social Aspects [ Time Frame: baseline, after 16 weeks and after 32 weeks ] [ Designated as safety issue: Yes ]
  • Quality of Life - SF-36 - Emotional Aspects [ Time Frame: baseline, after 16 weeks and after 32 weeks ] [ Designated as safety issue: Yes ]
  • Quality of Life - SF-36 - Mental Health [ Time Frame: baseline, after 16 weeks and after 32 weeks ] [ Designated as safety issue: Yes ]
  • Depression - Beck Inventory [ Time Frame: Baseline, after 16 weeks and after 32 weeks ] [ Designated as safety issue: Yes ]
  • Self-image - Body Dysmorphic Disorder Examination Questionnaire [ Time Frame: Baseline, after 16 weeks and after 32 weeks ] [ Designated as safety issue: Yes ]

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).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Federal University of São Paulo

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

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
Nervous System Diseases
Neuromuscular Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 21, 2014