Aquatic Physical Therapy in Fibromyalgia

This study has been completed.
Sponsor:
Information provided by:
Sao Camilo University Center
ClinicalTrials.gov Identifier:
NCT00615654
First received: February 1, 2008
Last updated: October 17, 2008
Last verified: January 2008
  Purpose

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.


Condition Intervention Phase
Fibromyalgia
Other: aquatic physical therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial of Aquatic Physiotherapy Program on Functional Capacity in Patients With Fibromyalgia.

Resource links provided by NLM:


Further study details as provided by Sao Camilo University Center:

Primary Outcome Measures:
  • functional capacity [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: January 2007
Study Completion Date: April 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
2 Other: 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00615654

Locations
Brazil
São Camilo University Center
São Paulo, SP, Brazil, 04263 - 200
Sponsors and Collaborators
Sao Camilo University Center
Investigators
Principal Investigator: Rafaela O Gimenes, Ms São Camilo University Center
  More Information

No publications provided

Responsible Party: Physiotherapy Department, Clinical School São Camilo
ClinicalTrials.gov Identifier: NCT00615654     History of Changes
Other Study ID Numbers: 01, 01
Study First Received: February 1, 2008
Last Updated: October 17, 2008
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Sao Camilo University Center:
Hydrotherapy,
RCT,

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on August 28, 2014