- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01029041
Stretching and Strengthening Exercise in Fibromyalgia Patients
December 8, 2009 updated by: University of Sao Paulo General Hospital
Stretching and Strengthening Exercise in Treatment of Fibromyalgia Patients: a Randomized Clinical Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
In this study, were included subjects with fibromyalgia diagnosis aged between 30 and 55 years old.
We aimed to assess the effect of a physical therapy program on impact of fibromyalgia syndrome and quality of life.
Study Type
Interventional
Enrollment (Actual)
63
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Sao Paulo, Brazil, 01246903
- Medicine School of University of Sao Paulo
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Fibromyalgia diagnosis according to American Rheumatology Criteria
- Aged between 30 and 55 years old
Exclusion Criteria:
- Severe rheumatologic syndromes
- neurologic syndromes
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Strengthening exercise
This group does global strengthening exercise
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Exercises that aim the improvement of muscular strength of arms and legs
Other Names:
|
|
Experimental: Stretching exercise
This group does global stretching exercise
|
Exercises that aim the improvement of muscular flexibility of arms, legs and spine
Other Names:
|
|
No Intervention: Control
This group does nor do any kind of exercise during the study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Fibromyalgia Impact Questionnaire
Time Frame: before and after treatment
|
before and after treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Medical Outcomes Study 36-item Short-Form Health Survey (SF-36), Stanford Health Assessment Questionnaire
Time Frame: before and after treatment
|
before and after treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2007
Primary Completion (Actual)
October 1, 2009
Study Completion (Actual)
November 1, 2009
Study Registration Dates
First Submitted
December 8, 2009
First Submitted That Met QC Criteria
December 8, 2009
First Posted (Estimate)
December 9, 2009
Study Record Updates
Last Update Posted (Estimate)
December 9, 2009
Last Update Submitted That Met QC Criteria
December 8, 2009
Last Verified
December 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Cappesq 0337/07
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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