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Effectiveness of Physical Exercise in Women With Fibromyalgia

Primary Purpose

Fibromyalgia

Status

Unknown status

Phase

Phase 2

Locations

Brazil

Study Type

Interventional

Intervention

walking program, resistance muscular exercise

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Exercise, Rehabilitation, Strength exercise, Aerobic exercise, Pain

Eligibility Criteria

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

Inclusion Criteria:

Criteria diagnosis according ACR 1990
Wash-out of medication specific for fibromyalgia for 1 month
Only paracetamol 750mg will be allowed during the period of study.

Exclusion Criteria:

Alterations that against indicate the practical one of physical activity evaluated previously in clinical and rheumatology evaluation

Sites / Locations

University of Santo Amaro - Ambulatory of Special ConditionsRecruiting

Outcomes

Primary Outcome Measures

Decrease of pain and use of specific medicine for fibromyalgia

Secondary Outcome Measures

Improvement on phsysical function assessment throughout of 6 minute walk test and specific questionnaire: FIQ (Fibromyalgia Impact questionnarie) and SF-36 (Quality of life)

Full Information

NCT ID

NCT00498264

First Posted

July 9, 2007

Last Updated

July 9, 2007

Sponsor

Federal University of São Paulo

Collaborators

University of Santo Amaro

1. Study Identification

Unique Protocol Identification Number

NCT00498264

Brief Title

Effectiveness of Physical Exercise in Women With Fibromyalgia

Official Title

Effectiveness of Physical Exercise on Decrease of Pain in Patients With Fibromyalgia:Randomized Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

June 2007

Overall Recruitment Status

Unknown status

Study Start Date

January 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

October 2007 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Federal University of São Paulo

Collaborators

University of Santo Amaro

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Fibromyalgia (FMS) is a syndrome expressed by chronic widespread body pain which leads to reduced physical function and frequent use of health care services. Exercise training is commonly recommended as a treatment. The purpose of this study is to determine whether a supervised resistance muscular exercise (RME) and walking program (WP) are effective in the treatment of FMS on decrease of pain. The practical of the RME reduces the pain of participants with FMS.

Detailed Description

This study will evaluate and compare the effectiveness of a supervised resistance muscular exercise (RME) , walking program (WP)and control group (just observation) in women with FMS during 16 weeks, on decrease of pain. Participants will undergo an assessment including medical some questionnaires to assess their FMS symptoms at baseline, after 8 weeks, 16 weeks and 28 weeks.

6. Conditions and Keywords

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

Fibromyalgia

Keywords

Exercise, Rehabilitation, Strength exercise, Aerobic exercise, Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Single

Allocation

Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Behavioral

Intervention Name(s)

walking program, resistance muscular exercise

Primary Outcome Measure Information:

Title

Decrease of pain and use of specific medicine for fibromyalgia

Time Frame

16 weeks

Secondary Outcome Measure Information:

Title

Improvement on phsysical function assessment throughout of 6 minute walk test and specific questionnaire: FIQ (Fibromyalgia Impact questionnarie) and SF-36 (Quality of life)

Time Frame

16 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Criteria diagnosis according ACR 1990 Wash-out of medication specific for fibromyalgia for 1 month Only paracetamol 750mg will be allowed during the period of study. Exclusion Criteria: Alterations that against indicate the practical one of physical activity evaluated previously in clinical and rheumatology evaluation

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Andrea H Kayo, PT

Phone

55-11-56682517

ahkayo@uol.com.br

First Name & Middle Initial & Last Name or Official Title & Degree

Mauro Ishioka, Secretary

Phone

55-11-55752970

ishioka.dmed@epm.br

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrea H Kayo, PT

Organizational Affiliation

Federal University of São Paulo

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Santo Amaro - Ambulatory of Special Conditions

City

São Paulo

ZIP/Postal Code

04815-180

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Carla M Sanches, Physican

Phone

55-11-56682500

Ext

2513

carlasanches@globo.com

First Name & Middle Initial & Last Name & Degree

Carla M Sanches, Physician

12. IPD Sharing Statement

Citations:

PubMed Identifier

21594719

Citation

Kayo AH, Peccin MS, Sanches CM, Trevisani VF. Effectiveness of physical activity in reducing pain in patients with fibromyalgia: a blinded randomized clinical trial. Rheumatol Int. 2012 Aug;32(8):2285-92. doi: 10.1007/s00296-011-1958-z. Epub 2011 May 19.

Results Reference

derived

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Effectiveness of Physical Exercise in Women With Fibromyalgia

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