Aquatic Physical Therapy in Fibromyalgia
Primary Purpose
Fibromyalgia
Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
aquatic physical therapy
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia focused on measuring Hydrotherapy,, RCT,
Eligibility 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
Sites / Locations
- São Camilo University Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
2
Arm Description
Outcomes
Primary Outcome Measures
functional capacity
Secondary Outcome Measures
Full Information
NCT ID
NCT00615654
First Posted
February 1, 2008
Last Updated
October 17, 2008
Sponsor
Sao Camilo University Center
1. Study Identification
Unique Protocol Identification Number
NCT00615654
Brief Title
Aquatic Physical Therapy in Fibromyalgia
Official Title
A Randomized Clinical Trial of Aquatic Physiotherapy Program on Functional Capacity in Patients With Fibromyalgia.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
April 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sao Camilo University Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Hydrotherapy,, RCT,
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
aquatic physical therapy
Intervention Description
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 Measure Information:
Title
functional capacity
Time Frame
2 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rafaela O Gimenes, Ms
Organizational Affiliation
São Camilo University Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
São Camilo University Center
City
São Paulo
State/Province
SP
ZIP/Postal Code
04263 - 200
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Aquatic Physical Therapy in Fibromyalgia
We'll reach out to this number within 24 hrs