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
  Purpose

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.


Condition Intervention
Fibromyalgia Syndrome
Other: Strengthening Exercises
Other: Stretching exercises

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Stretching and Strengthening Exercise in Treatment of Fibromyalgia Patients: a Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • Fibromyalgia Impact Questionnaire [ Time Frame: before and after treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 63
Study Start Date: August 2007
Study Completion Date: November 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Strengthening exercise
This group does global strengthening exercise
Other: Strengthening Exercises
Exercises that aim the improvement of muscular strength of arms and legs
Other Name: strengh exercise
Experimental: Stretching exercise
This group does global stretching exercise
Other: Stretching exercises
Exercises that aim the improvement of muscular flexibility of arms, legs and spine
Other Name: flexibility exercise
No Intervention: Control
This group does nor do any kind of exercise during the study

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.

  Eligibility

Ages Eligible for Study:   30 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Severe rheumatologic syndromes
  • neurologic syndromes
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01029041

Locations
Brazil
Medicine School of University of Sao Paulo
Sao Paulo, Brazil, 01246903
Sponsors and Collaborators
University of Sao Paulo General Hospital
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Study Chair: Amélia P Marques, PhD University of São Paulo
  More Information

Additional Information:
No publications provided

Responsible Party: Ana Assumpção Berssaneti, Medicine School of University of São Paulo
ClinicalTrials.gov Identifier: NCT01029041     History of Changes
Other Study ID Numbers: Cappesq 0337/07
Study First Received: December 8, 2009
Last Updated: December 8, 2009
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo General Hospital:
fibromyalgia, exercise, strength, stretch

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 23, 2014