Aquatic Physical Therapy in Fibromyalgia | NCT00615654

Studies
Aquatic Physical Therapy in Fibromyalgia

NCT00615654

Sponsor

Sao Camilo University Center

Status

Completed

Last Update Posted

Oct 20, 2008Estimated

Enrollment

40Actual

Phase

Phase 3

Conditions

Fibromyalgia

Interventions

aquatic physical therapy

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

ID	Type	Description	Link
01

Status Module

Record Verification Date

Jan 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Feb 2007Actual

Completion Date

Apr 2007Actual

First Submitted Date

Feb 1, 2008

First Submission Date that Met QC Criteria

Feb 13, 2008

First Posted Date

Feb 14, 2008Estimated

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

Oct 17, 2008

Last Update Posted Date

Oct 20, 2008Estimated

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

Objective: To investigate whether patients undergoing aquatic physiotherapy in groups improve their functional capacity, by means of the distance covered in the six-minute walk test (6WT), and to compare this with a control group. Methods: Forty women that had not been practicing regular physical activity for one year were randomly allocated either to the Study Group (SG) to undergo an aquatic physiotherapy program in groups applied twice a week, including aerobic exercises, muscle strengthening and relaxation for 12 weeks, or to the Control Group (CG), which did not do any physical activity. Both groups maintained their treatment with medications. All patients underwent two evaluations: one at the start and the other after 12 weeks.

Detailed Description

Not provided

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
2	Other		Other: aquatic physical therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
aquatic physical therapy	Other	The aquatic physiotherapy program for the SG was applied twice a week, in groups of six to seven people, with sessions lasting 40 minutes, over a 12-week period. The Control Group protocol included maintenance of the individuals' medication therapy and absence of any physical activity during the study period.

Measure	Description	Time Frame
functional capacity		2 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients of both genders with a medical diagnosis of FS, without age restrictions and without impaired cognition, who had not been practicing regular physical activity for one year

Exclusion Criteria:

Presence of other rheumatic diseases and cardiovascular problems
Smoking
Absence of medical permission for swimming pool activities
Starting other therapies, or changes to and/or discontinuation of medical treatment

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rafaela O Gimenes, Ms	São Camilo University Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
São Camilo University Center		São Paulo	São Paulo	04263 - 200	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D005356	Fibromyalgia

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided