Effectiveness of Physical Exercise in Women With Fibromyalgia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2007 by Federal University of São Paulo.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University of Santo Amaro
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00498264
First received: July 9, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Effectiveness of Physical Exercise on Decrease of Pain in Patients With Fibromyalgia:Randomized Clinical Trial

Resource links provided by NLM:


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
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: 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

No publications provided by Federal University of São Paulo

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00498264     History of Changes
Other Study ID Numbers: AHK12121977
Study First Received: July 9, 2007
Last Updated: July 9, 2007
Health Authority: Brazil: National Committee of Ethics in Research

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

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 28, 2014