Stretching and Strengthening Exercise in Fibromyalgia Patients

This study has been completed.
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01029041
First received: December 8, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted

December 8, 2009
December 8, 2009
August 2007
October 2009   (final data collection date for primary outcome measure)
Fibromyalgia Impact Questionnaire [ Time Frame: before and after treatment ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
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 ]
Same as current
 
 
 
Stretching and Strengthening Exercise in Fibromyalgia Patients
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.

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.

Interventional
 
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Fibromyalgia Syndrome
  • Other: Strengthening Exercises
    Exercises that aim the improvement of muscular strength of arms and legs
    Other Name: strengh exercise
  • Other: Stretching exercises
    Exercises that aim the improvement of muscular flexibility of arms, legs and spine
    Other Name: flexibility exercise
  • Experimental: Strengthening exercise
    This group does global strengthening exercise
    Intervention: Other: Strengthening Exercises
  • Experimental: Stretching exercise
    This group does global stretching exercise
    Intervention: Other: Stretching exercises
  • No Intervention: Control
    This group does nor do any kind of exercise during the study
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
63
November 2009
October 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Severe rheumatologic syndromes
  • neurologic syndromes
Female
30 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01029041
Cappesq 0337/07
No
Ana Assumpção Berssaneti, Medicine School of University of São Paulo
University of Sao Paulo General Hospital
Fundação de Amparo à Pesquisa do Estado de São Paulo
Study Chair: Amélia P Marques, PhD University of São Paulo
University of Sao Paulo General Hospital
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP