Effectiveness of Physical Exercise in Women With Fibromyalgia

NCT ID: NCT00498264

Last Updated: 2007-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2007-10-31

Brief Summary

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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

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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.

Conditions

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Fibromyalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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walking program, resistance muscular exercise

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Santo Amaro

OTHER

Sponsor Role collaborator

Federal University of São Paulo

OTHER

Sponsor Role lead

Principal Investigators

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Andrea H Kayo, PT

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Locations

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University of Santo Amaro - Ambulatory of Special Conditions

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Andrea H Kayo, PT

Role: CONTACT

55-11-56682517

Mauro Ishioka, Secretary

Role: CONTACT

55-11-55752970

Facility Contacts

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Carla M Sanches, Physican

Role: primary

55-11-56682500 ext. 2513

References

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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.

Reference Type DERIVED
PMID: 21594719 (View on PubMed)

Other Identifiers

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AHK12121977

Identifier Type: -

Identifier Source: org_study_id