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Aquatic Physical Therapy in Fibromyalgia

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ClinicalTrials.gov Identifier: NCT00615654
Recruitment Status : Completed
First Posted : February 14, 2008
Last Update Posted : October 20, 2008
Sponsor:
Information provided by:
Sao Camilo University Center

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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Other: aquatic physical therapy Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial of Aquatic Physiotherapy Program on Functional Capacity in Patients With Fibromyalgia.
Study Start Date : January 2007
Actual Primary Completion Date : February 2007
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. functional capacity [ Time Frame: 2 months ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00615654


Locations
Brazil
São Camilo University Center
São Paulo, SP, Brazil, 04263 - 200
Sponsors and Collaborators
Sao Camilo University Center
Investigators
Principal Investigator: Rafaela O Gimenes, Ms São Camilo University Center

Responsible Party: Physiotherapy Department, Clinical School São Camilo
ClinicalTrials.gov Identifier: NCT00615654     History of Changes
Other Study ID Numbers: 01
01
First Posted: February 14, 2008    Key Record Dates
Last Update Posted: October 20, 2008
Last Verified: January 2008

Keywords provided by Sao Camilo University Center:
Hydrotherapy,
RCT,

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases