Aquatic Physical Therapy in Fibromyalgia

October 17, 2008 updated by: Sao Camilo University Center

A Randomized Clinical Trial of Aquatic Physiotherapy Program on Functional Capacity in Patients With Fibromyalgia.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 04263 - 200
        • São Camilo University Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 2
Other: aquatic physical therapy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
functional capacity
Time Frame: 2 months
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sao Camilo University Center

Investigators

  • Principal Investigator: Rafaela O Gimenes, Ms, São Camilo University Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

February 1, 2007

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

February 1, 2008

First Submitted That Met QC Criteria

February 13, 2008

First Posted (Estimate)

February 14, 2008

Study Record Updates

Last Update Posted (Estimate)

October 20, 2008

Last Update Submitted That Met QC Criteria

October 17, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01 (Miami VAHS)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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