Aquatic Physical Therapy in Fibromyalgia
A Randomized Clinical Trial of Aquatic Physiotherapy Program on Functional Capacity in Patients With Fibromyalgia.
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 2007
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 1, 2008
CompletedFirst Posted
Study publicly available on registry
February 14, 2008
CompletedOctober 20, 2008
January 1, 2008
1 month
February 1, 2008
October 17, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
functional capacity
2 months
Study Arms (1)
2
OTHERInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
São Camilo University Center
São Paulo, São Paulo, 04263 - 200, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rafaela O Gimenes, Ms
São Camilo University Center
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 1, 2008
First Posted
February 14, 2008
Study Start
January 1, 2007
Primary Completion
February 1, 2007
Study Completion
April 1, 2007
Last Updated
October 20, 2008
Record last verified: 2008-01