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Effectiveness of Physical Exercise in Women With Fibromyalgia

This study is currently recruiting participants.
Verified by Federal University of São Paulo, June 2007

Sponsors and Collaborators: Federal University of São Paulo
University of Santo Amaro
Information provided by: Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT00498264
  Purpose

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 Intervention Phase
Fibromyalgia
Behavioral: walking program, resistance muscular exercise
Phase II

MedlinePlus related topics:   Exercise and Physical Fitness    Fibromyalgia   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Single Blind, Active Control, Parallel Assignment
Official Title:   Effectiveness of Physical Exercise on Decrease of Pain in Patients With Fibromyalgia:Randomized Clinical Trial

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

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment:   90
Study Start Date:   January 2005
Estimated Study Completion Date:   October 2007

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.

  Eligibility
Ages Eligible for Study:   35 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00498264

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

Locations
Brazil
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

Investigators
Principal Investigator:     Andrea H Kayo, PT     Federal University of São Paulo    
  More Information


Study ID Numbers:   AHK12121977
First Received:   July 9, 2007
Last Updated:   July 9, 2007
ClinicalTrials.gov Identifier:   NCT00498264
Health Authority:   Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of São Paulo:
Exercise  
Rehabilitation  
Strength exercise  
Aerobic exercise  
Pain  

Study placed in the following topic categories:
Muscular Diseases
Neuromuscular Diseases
Musculoskeletal Diseases
Myofascial Pain Syndromes
Fibromyalgia
Pain
Rheumatic Diseases

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on October 06, 2008




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