NCT00498264

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2005

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

July 9, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 10, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

July 10, 2007

Status Verified

June 1, 2007

First QC Date

July 9, 2007

Last Update Submit

July 9, 2007

Conditions

Fibromyalgia

Keywords

ExerciseRehabilitationStrength exerciseAerobic exercisePain

Outcome Measures

Primary Outcomes (1)

  • Decrease of pain and use of specific medicine for fibromyalgia

    16 weeks

Secondary Outcomes (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)

    16 weeks

Interventions

walking program, resistance muscular exerciseBEHAVIORAL

Eligibility Criteria

Age35 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Santo Amaro - Ambulatory of Special Conditions

São Paulo, São Paulo, 04815-180, Brazil

RECRUITING

Related Publications (1)

  • Kayo AH, Peccin MS, Sanches CM, Trevisani VF. Effectiveness of physical activity in reducing pain in patients with fibromyalgia: a blinded randomized clinical trial. Rheumatol Int. 2012 Aug;32(8):2285-92. doi: 10.1007/s00296-011-1958-z. Epub 2011 May 19.

    PMID: 21594719DERIVED

MeSH Terms

Conditions

FibromyalgiaMotor ActivityPain

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesBehaviorNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Andrea H Kayo, PT

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea H Kayo, PT

CONTACT

55-11-56682517ahkayo@uol.com.br

Mauro Ishioka, Secretary

CONTACT

55-11-55752970ishioka.dmed@epm.br

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 9, 2007

First Posted

July 10, 2007

Study Start

January 1, 2005

Study Completion

October 1, 2007

Last Updated

July 10, 2007

Record last verified: 2007-06

Locations

BR(1)