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Stretching and Strengthening Exercise in Fibromyalgia Patients

Primary Purpose

Fibromyalgia Syndrome

Status

Completed

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Strengthening Exercises

Stretching exercises

About this trial

This is an interventional treatment trial for Fibromyalgia Syndrome focused on measuring fibromyalgia, exercise, strength, stretch

Eligibility Criteria

30 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Severe rheumatologic syndromes
neurologic syndromes

Sites / Locations

Medicine School of University of Sao Paulo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

Strengthening exercise

Stretching exercise

Control

Arm Description

This group does global strengthening exercise

This group does global stretching exercise

This group does nor do any kind of exercise during the study

Outcomes

Primary Outcome Measures

Fibromyalgia Impact Questionnaire

Secondary Outcome Measures

Medical Outcomes Study 36-item Short-Form Health Survey (SF-36), Stanford Health Assessment Questionnaire

Full Information

NCT ID

NCT01029041

First Posted

December 8, 2009

Last Updated

December 8, 2009

Sponsor

University of Sao Paulo General Hospital

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

1. Study Identification

Unique Protocol Identification Number

NCT01029041

Brief Title

Stretching and Strengthening Exercise in Fibromyalgia Patients

Official Title

Stretching and Strengthening Exercise in Treatment of Fibromyalgia Patients: a Randomized Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

December 2009

Overall Recruitment Status

Completed

Study Start Date

August 2007 (undefined)

Primary Completion Date

October 2009 (Actual)

Study Completion Date

November 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Sao Paulo General Hospital

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fibromyalgia Syndrome

Keywords

fibromyalgia, exercise, strength, stretch

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

63 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Strengthening exercise

Arm Type

Experimental

Arm Description

This group does global strengthening exercise

Arm Title

Stretching exercise

Arm Type

Experimental

Arm Description

This group does global stretching exercise

Arm Title

Control

Arm Type

No Intervention

Arm Description

This group does nor do any kind of exercise during the study

Intervention Type

Other

Intervention Name(s)

Strengthening Exercises

Other Intervention Name(s)

strengh exercise

Intervention Description

Exercises that aim the improvement of muscular strength of arms and legs

Intervention Type

Other

Intervention Name(s)

Stretching exercises

Other Intervention Name(s)

flexibility exercise

Intervention Description

Exercises that aim the improvement of muscular flexibility of arms, legs and spine

Primary Outcome Measure Information:

Title

Fibromyalgia Impact Questionnaire

Time Frame

before and after treatment

Secondary Outcome Measure Information:

Title

Medical Outcomes Study 36-item Short-Form Health Survey (SF-36), Stanford Health Assessment Questionnaire

Time Frame

before and after treatment

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Fibromyalgia diagnosis according to American Rheumatology Criteria Aged between 30 and 55 years old Exclusion Criteria: Severe rheumatologic syndromes neurologic syndromes

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Amélia P Marques, PhD

Organizational Affiliation

University of São Paulo

Official's Role

Study Chair

Facility Information:

Facility Name

Medicine School of University of Sao Paulo

City

Sao Paulo

ZIP/Postal Code

01246903

Country

Brazil

12. IPD Sharing Statement

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Stretching and Strengthening Exercise in Fibromyalgia Patients

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