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Clinical Trials/NCT00615654
NCT00615654CompletedPhase 3

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

Sao Camilo University Center2 sites in 1 country40 target enrollmentStarted: January 1, 2007Last updated:
Conditions

Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
Enrollment
40
Locations
2
Primary Endpoint
functional capacity

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
Yes

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
  • Absence of medical permission for swimming pool activities
  • Starting other therapies, or changes to and/or discontinuation of medical treatment

Outcomes

Primary Outcomes

functional capacity

Time Frame: 2 months

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Sao Camilo University Center
Sponsor Class
Other

Study Sites (2)

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