Stretching and Strengthening Exercise in Fibromyalgia Patients
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...
Brief Summary
Official Title: “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 Type: Interventional
- Study Design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: October 2009
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- Other: Strengthening Exercises
- Exercises that aim the improvement of muscular strength of arms and legs
- Other: Stretching exercises
- Exercises that aim the improvement of muscular flexibility of arms, legs and spine
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: Strengthening exercise
- This group does global strengthening exercise
- Experimental: Stretching exercise
- This group does global stretching exercise
- No Intervention: Control
- This group does nor do any kind of exercise during the study
Outcome Measures for this Clinical Trial
Primary Measures
- Fibromyalgia Impact Questionnaire
- Time Frame: before and after treatment
Safety Issue?: Yes
- Time Frame: before and after treatment
Secondary Measures
- Medical Outcomes Study 36-item Short-Form Health Survey (SF-36), Stanford Health Assessment Questionnaire
- Time Frame: before and after treatment
Safety Issue?: Yes
- Time Frame: before and after treatment
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Fibromyalgia diagnosis according to American Rheumatology Criteria
- Aged between 30 and 55 years old
Exclusion Criteria:
- Severe rheumatologic syndromes
- neurologic syndromes
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 30 Years
Maximum Age for this Clinical Trial: 55 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: University of Sao Paulo General Hospital Other
Overall Clinical Trial Officials and Contacts
Amélia P Marques, PhD Study Chair University of São Paulo
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01029041
Study ID Number: Cappesq 0337/07
ClinicalTrials.gov Identifier: NCT01029041
Health Authority: Brazil: Ethics Committee
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01029041
