Stretching and Strengthening Exercise in Fibromyalgia Patients
Tracking Information | |||||
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First Received Date ICMJE | December 8, 2009 | ||||
Last Updated Date | December 8, 2009 | ||||
Start Date ICMJE | August 2007 | ||||
Primary Completion Date | October 2009 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Fibromyalgia Impact Questionnaire [ Time Frame: before and after treatment ] [ Designated as safety issue: Yes ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE |
Medical Outcomes Study 36-item Short-Form Health Survey (SF-36), Stanford Health Assessment Questionnaire [ Time Frame: before and after treatment ] [ Designated as safety issue: Yes ] | ||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Stretching and Strengthening Exercise in Fibromyalgia Patients | ||||
Official Title ICMJE | Stretching and Strengthening Exercise in Treatment of Fibromyalgia Patients: a Randomized Clinical Trial | ||||
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. |
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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. |
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Study Type ICMJE | Interventional | ||||
Study Phase | |||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Fibromyalgia Syndrome | ||||
Intervention ICMJE |
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Study Arm (s) |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 63 | ||||
Completion Date | November 2009 | ||||
Primary Completion Date | October 2009 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Female | ||||
Ages | 30 Years to 55 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | Brazil | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT01029041 | ||||
Other Study ID Numbers ICMJE | Cappesq 0337/07 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Ana Assumpção Berssaneti, Medicine School of University of São Paulo | ||||
Study Sponsor ICMJE | University of Sao Paulo General Hospital | ||||
Collaborators ICMJE | Fundação de Amparo à Pesquisa do Estado de São Paulo | ||||
Investigators ICMJE |
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Information Provided By | University of Sao Paulo General Hospital | ||||
Verification Date | December 2009 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |