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CompletedNCT00615654Updated Oct 20, 2008

Aquatic Physical Therapy in Fibromyalgia

A Phase 3 interventional study of aquatic physical therapy in Fibromyalgia, sponsored by Sao Camilo University Center. Completed at 1 site in Brazil. Per ClinicalTrials.gov, last updated 2008-10-20.

Sponsored by Sao Camilo University Center · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
40
Allocation
Randomized
Sex
All
01

Study 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.

02

Conditions studied

  • Fibromyalgia

Keywords

  • Hydrotherapy,
  • RCT,
03

In context

Fibromyalgia

1,336 studies on the registry are indexed under Fibromyalgia; 266 are open to participants now.

This study's enrollment of 40 is below the median of 60 across 1,035 interventional studies indexed under Fibromyalgia.

Browse Fibromyalgia studies →

Lead sponsor

Sao Camilo University Center is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Care provider, Investigator, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Other
    2

    Other: aquatic physical therapy

Interventions

  • Otheraquatic 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.

06

What researchers measure

Primary outcomes

  1. functional capacity

    Time frame: 2 months

07

Study locations

1 site
  • São Camilo University Center
    São Paulo, SP 04263 - 200, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 20, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00615654
Lead sponsor
Sao Camilo University Center
First posted
Feb 14, 2008
Start date
Jan 2007
Primary completion
Feb 2007
Completion
Apr 2007
Last update
Oct 20, 2008

Study contacts

Rafaela O Gimenes, Ms
principal investigator · São Camilo University Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2008. You cannot join it, but the record below documents what was studied.

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