Effectiveness of Physical Exercise in Women With Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

Effectiveness of Physical Exercise on Decrease of Pain in Patients With Fibromyalgia:Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00498264
• Other study ID #: AHK12121977
• Status: Recruiting
• Phase: Phase 2
• First received: July 9, 2007
• Last updated: July 9, 2007
• Start date: January 2005
• Est. completion date: October 2007

Study information

• Verified date: June 2007
• Source: Federal University of São Paulo
• Contact: Andrea H Kayo, PT
• Phone: 55-11-56682517
• Email: ahkayo[@]uol.com.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Behavioral:
• walking program, resistance muscular exercise

Locations

Country	Name	City	State
Brazil	University of Santo Amaro - Ambulatory of Special Conditions	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of São Paulo	University of Santo Amaro

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease of pain and use of specific medicine for fibromyalgia		16 weeks
Secondary	Improvement on phsysical function assessment throughout of 6 minute walk test and specific questionnaire: FIQ (Fibromyalgia Impact questionnarie) and SF-36 (Quality of life)		16 weeks