Effectiveness of Physical Exercise in Women With Fibromya... | NCT00498264

Studies
Effectiveness of Physical Exercise in Women With Fibromyalgia

NCT00498264

Sponsor

Federal University of São Paulo

Status

Unknown status

Last Update Posted

Jul 10, 2007Estimated

Enrollment

90Estimated

Phase

Phase 2

Conditions

Fibromyalgia

Interventions

walking program, resistance muscular exercise

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2005

Primary Completion Date

Not provided

Completion Date

Oct 2007Estimated

First Submitted Date

Jul 9, 2007

First Submission Date that Met QC Criteria

Jul 9, 2007

First Posted Date

Jul 10, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 9, 2007

Last Update Posted Date

Jul 10, 2007Estimated

Name	Class
Universidade Santo Amaro	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Name	Type	Description	Arm Group Labels	Other Names
walking program, resistance muscular exercise	Behavioral

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Decrease of pain and use of specific medicine for fibromyalgia		16 weeks

Secondary Outcomes

Measure	Description	Time Frame
Improvement on phsysical function assessment throughout of 6 minute walk test and specific questionnaire: FIQ (Fibromyalgia Impact questionnarie) and SF-36 (Quality of life)		16 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Andrea H Kayo, PT	Contact	55-11-56682517		ahkayo@uol.com.br
Mauro Ishioka, Secretary	Contact	55-11-55752970		ishioka.dmed@epm.br

Overall Officials

Name	Affiliation	Role
Andrea H Kayo, PT	Federal University of São Paulo	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Santo Amaro - Ambulatory of Special Conditions	Recruiting	São Paulo	São Paulo	04815-180	Brazil

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21594719	Derived	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.

ID	Term
D005356	Fibromyalgia
D009043	Motor Activity
D010146	Pain

ID	Term
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D009468	Neuromuscular Diseases