Aquatic Physical Therapy in Fibromyalgia

NCT ID: NCT00615654

Last Updated: 2008-10-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2007-04-30

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.

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

2

Group Type: OTHER

aquatic physical therapy

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sao Camilo University Center

OTHER

Sponsor Role: lead

Responsible Party

Clinical School São Camilo

Principal Investigators

Rafaela O Gimenes, Ms

Role: PRINCIPAL_INVESTIGATOR

São Camilo University Center

Locations

São Camilo University Center

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

01

Identifier Type: -

Identifier Source: secondary_id

01

Identifier Type: -

Identifier Source: org_study_id