Stretching and Strengthening Exercise in Fibromyalgia Patients
1 other identifier
interventional
63
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2007
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 8, 2009
CompletedFirst Posted
Study publicly available on registry
December 9, 2009
CompletedDecember 9, 2009
December 1, 2009
2.2 years
December 8, 2009
December 8, 2009
Conditions
Keywords
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
EXPERIMENTALThis group does global strengthening exercise
Stretching exercise
EXPERIMENTALThis group does global stretching exercise
Control
NO INTERVENTIONThis group does nor do any kind of exercise during the study
Interventions
Exercises that aim the improvement of muscular strength of arms and legs
Exercises that aim the improvement of muscular flexibility of arms, legs and spine
Eligibility Criteria
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Amélia P Marques, PhD
University of Sao Paulo
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