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Effectiveness of Physical Exercise in Women With Fibromyalgia

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.
ClinicalTrials.gov Identifier: NCT00498264
Recruitment Status : Unknown
Verified June 2007 by Federal University of São Paulo.
Recruitment status was:  Recruiting
First Posted : July 10, 2007
Last Update Posted : July 10, 2007
University of Santo Amaro
Information provided by:
Federal University of São Paulo

Brief Summary:

Fibromyalgia (FMS) is a syndrome expressed by chronic widespread body pain which leads to reduced physical function and frequent use of health care services. Exercise training is commonly recommended as a treatment.

The purpose of this study is to determine whether a supervised resistance muscular exercise (RME) and walking program (WP) are effective in the treatment of FMS on decrease of pain.

The practical of the RME reduces the pain of participants with FMS.

Condition or disease Intervention/treatment Phase
Fibromyalgia Behavioral: walking program, resistance muscular exercise Phase 2

Detailed Description:

This study will evaluate and compare the effectiveness of a supervised resistance muscular exercise (RME) , walking program (WP)and control group (just observation) in women with FMS during 16 weeks, on decrease of pain.

Participants will undergo an assessment including medical some questionnaires to assess their FMS symptoms at baseline, after 8 weeks, 16 weeks and 28 weeks.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Effectiveness of Physical Exercise on Decrease of Pain in Patients With Fibromyalgia:Randomized Clinical Trial
Study Start Date : January 2005
Estimated Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Primary Outcome Measures :
  1. Decrease of pain and use of specific medicine for fibromyalgia [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. Improvement on phsysical function assessment throughout of 6 minute walk test and specific questionnaire: FIQ (Fibromyalgia Impact questionnarie) and SF-36 (Quality of life) [ Time Frame: 16 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Criteria diagnosis according ACR 1990
  • Wash-out of medication specific for fibromyalgia for 1 month
  • Only paracetamol 750mg will be allowed during the period of study.

Exclusion Criteria:

  • Alterations that against indicate the practical one of physical activity evaluated previously in clinical and rheumatology evaluation

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): NCT00498264

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Contact: Andrea H Kayo, PT 55-11-56682517 ahkayo@uol.com.br
Contact: Mauro Ishioka, Secretary 55-11-55752970 ishioka.dmed@epm.br

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University of Santo Amaro - Ambulatory of Special Conditions Recruiting
São Paulo, Brazil, 04815-180
Contact: Carla M Sanches, Physican    55-11-56682500 ext 2513    carlasanches@globo.com   
Sub-Investigator: Carla M Sanches, Physician         
Sponsors and Collaborators
Federal University of São Paulo
University of Santo Amaro
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Principal Investigator: Andrea H Kayo, PT Federal University of São Paulo
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00498264    
Other Study ID Numbers: AHK12121977
First Posted: July 10, 2007    Key Record Dates
Last Update Posted: July 10, 2007
Last Verified: June 2007
Keywords provided by Federal University of São Paulo:
Strength exercise
Aerobic exercise
Additional relevant MeSH terms:
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Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases