NCT01029041

Brief Summary

Fibromyalgia is a rheumatologic syndrome characterized by widespread chronic pain, tender points and other symptoms as fatigue, sleep disturbances, anxiety and depression. Therapeutic exercises are described as an important form to management of symptoms. This study aims to assess strengthening and stretching exercise efficacy in symptoms and quality of life of Fibromyalgia patients. The study is done at General Clinical Hospital of Medicine Scholl of University of Sao Paulo. 63 subjects undergo the study and they are divided into three groups: 1 strengthening exercise, 2 stretching exercise and 3 control group. Patients are evaluated by following instruments: Fibromyalgia Impact Questionnaire, Medical Outcomes Study 36-item Short-Form Health Survey (SF-36), Stanford Health Assessment Questionnaire, dolorimetry at tender points by a Fischer dolorimeter, finger-to-tip floor test for muscular flexibility, dynamometer EMG System do Brasil for strength test of extension and flexion of knees and elbows, time to get up and go test, functional reach test, sit-to-stand test. Subjects of 1 strengthening exercise group undergo a global strengthening program and 2 stretching exercise group undergo a global stretching program. All programs have 12 weeks of duration and physical therapy is twice a week. The control group does not do any intervention during 12 weeks and after the second evaluation they enter the common program of physical therapy. Data are being analyzed by descriptive and interferential statistics procedures.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2007

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 9, 2009

Completed
Last Updated

December 9, 2009

Status Verified

December 1, 2009

Enrollment Period

2.2 years

First QC Date

December 8, 2009

Last Update Submit

December 8, 2009

Conditions

Keywords

fibromyalgia, exercise, strength, stretch

Outcome Measures

Primary Outcomes (1)

  • Fibromyalgia Impact Questionnaire

    before and after treatment

Secondary Outcomes (1)

  • Medical Outcomes Study 36-item Short-Form Health Survey (SF-36), Stanford Health Assessment Questionnaire

    before and after treatment

Study Arms (3)

Strengthening exercise

EXPERIMENTAL

This group does global strengthening exercise

Other: Strengthening Exercises

Stretching exercise

EXPERIMENTAL

This group does global stretching exercise

Other: Stretching exercises

Control

NO INTERVENTION

This group does nor do any kind of exercise during the study

Interventions

Exercises that aim the improvement of muscular strength of arms and legs

Also known as: strengh exercise
Strengthening exercise

Exercises that aim the improvement of muscular flexibility of arms, legs and spine

Also known as: flexibility exercise
Stretching exercise

Eligibility Criteria

Age30 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Fibromyalgia diagnosis according to American Rheumatology Criteria
  • Aged between 30 and 55 years old

You may not qualify if:

  • Severe rheumatologic syndromes
  • neurologic syndromes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medicine School of University of Sao Paulo

São Paulo, São Paulo, 01246903, Brazil

Location

MeSH Terms

Conditions

FibromyalgiaMotor Activity

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Amélia P Marques, PhD

    University of Sao Paulo

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 8, 2009

First Posted

December 9, 2009

Study Start

August 1, 2007

Primary Completion

October 1, 2009

Study Completion

November 1, 2009

Last Updated

December 9, 2009

Record last verified: 2009-12

Locations