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Effects of Swimming in the Treatment of Fibromyalgia (ESTF)

Primary Purpose

Fibromyalgia

Status
Unknown status
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
swim training
Training walk
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring fibromyalgia, swimming

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

INCLUSION CRITERIA:

  • Female patients with fibromyalgia according to the classification criteria of the American College of Rheumatology;
  • Patients with degree of pain between 4 and 8 cm by VAS-visual analog scale;
  • Patients who can swim the freestyle "(crawl)"; Patients with stable-medication for at least three months;
  • All patients will have signing the consent form.

EXCLUSION CRITERIA:

  • Patients with uncontrolled cardiac disease and / or unable to perform aerobic exercises;
  • Patients with severe psychiatric disorders;
  • Patients with uncontrolled diabetes mellitus;
  • Patients who practice regular physical exercise for at least 3 months;
  • Patients with skin diseases that contraindicate the use of swimming pool;
  • Patients with inflammatory rheumatic diseases.

Sites / Locations

  • Universidade Federal de São PauloRecruiting
  • Ambulatory at UNIFESPRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group-swimming

Control-walk

Arm Description

Outcomes

Primary Outcome Measures

Diminishing of pain
_ Assess the effectiveness of the practice of swimming in reducing pain and improving quality of life in patients with FM.

Secondary Outcome Measures

Improving quality of life
_ Assess the effectiveness of the practice of swimming in improved function and aerobic capacity in patients with FM.

Full Information

First Posted
February 21, 2012
Last Updated
March 28, 2012
Sponsor
Federal University of São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01547195
Brief Title
Effects of Swimming in the Treatment of Fibromyalgia
Acronym
ESTF
Official Title
Assessment of the Effects of Swimming in the Treatment of Patients With Fibromyalgia.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The recent scientific evidence shows that FM patients improve exercise capacity, symptoms and quality of life with the holding of regular exercise, especially aerobic exercise. Swimming is an aerobic workout of low impact, but no study has evaluated the effect of this activity in patients with fibromyalgia. Randomized controlled trial with blinded evaluator, which will be evaluated patients with fibromyalgia were divided into two groups. The intervention group will hold an exercise program of swimming (freestyle) and the other considered the control group held a walking program.
Detailed Description
Fibromyalgia (FM) is a syndrome characterized by diffuse musculoskeletal pain and chronic, with points called "hot spots", specific, sensitive and painful on palpation. Objective: To evaluate the efficacy of swimming in reducing the generally pain and improve the quality of function, of life and exercise capacity in patients with fibromyalgia. Material and Methods: 82 patients will be screened, diagnosed with fibromyalgia, who can swim the front crawl. Will be selected at UNIFESP outpatient clinics and also through advertisement in a newspaper. One group held the swimming training and the other group (control) will walk training. The Participants perform exercises (swimming or running) three times a week for 50 minutes, for 12 weeks. The exercises will be held at the anaerobic threshold determined by cardiopulmonary exercise testing. Measuring instrument: Questionnaires VAS (visual analogue scale) for pain, FIQ (Fibromyalgia Impact Questionnaire) to assess the quality of life related to disease, and also the SF-36 (short form health survey), which assesses quality of life in general. Cardiopulmonary stress test to assess cardiorespiratory fitness to sit and stand up and test to assess functional capacity. All participants will conduct an initial evaluation, after 6 and 13 weeks of training.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
fibromyalgia, swimming

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group-swimming
Arm Type
Experimental
Arm Title
Control-walk
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
swim training
Other Intervention Name(s)
Swimming., Freestyle.
Intervention Description
Swimming training will be conducted with the implementation of the freestyle. The training will be held a week with 3 X 50 minutes for a period of 12 weeks. Patients will be monitored by a frequency waterproof. When at the beginning of training are carried out five minutes of heating, followed by 40minutos swimming 5 minutes and cooling at the end of training.
Intervention Type
Procedure
Intervention Name(s)
Training walk
Other Intervention Name(s)
Walk.
Intervention Description
The control group will perform walking exercise outdoors, monitored by a frequency, with the heart rate at anaerobic threshold assessed by cardiopulmonary exercise test. The training of walking will last 50 minutes, three times per week for 12 weeks. At the beginning of training, there will be a heating time of 5 minutes, followed by LA walk in cooling for 40 minutes and 5 minutes.
Primary Outcome Measure Information:
Title
Diminishing of pain
Description
_ Assess the effectiveness of the practice of swimming in reducing pain and improving quality of life in patients with FM.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Improving quality of life
Description
_ Assess the effectiveness of the practice of swimming in improved function and aerobic capacity in patients with FM.
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA: Female patients with fibromyalgia according to the classification criteria of the American College of Rheumatology; Patients with degree of pain between 4 and 8 cm by VAS-visual analog scale; Patients who can swim the freestyle "(crawl)"; Patients with stable-medication for at least three months; All patients will have signing the consent form. EXCLUSION CRITERIA: Patients with uncontrolled cardiac disease and / or unable to perform aerobic exercises; Patients with severe psychiatric disorders; Patients with uncontrolled diabetes mellitus; Patients who practice regular physical exercise for at least 3 months; Patients with skin diseases that contraindicate the use of swimming pool; Patients with inflammatory rheumatic diseases.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giovana Fernandes, Mestranda
Phone
+55 11 25943375
Email
gifernandespersonal@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giovana Fernandes, Mestranda
Organizational Affiliation
Universidade Federal de São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade Federal de São Paulo
City
São Paulo
State/Province
SP
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jamil Natour, Professor
Phone
+55 11 55764239
Email
jnatour@unifesp.com.br
First Name & Middle Initial & Last Name & Degree
Giovana Fernandes, Mestranda
Phone
+55 11 25943375
First Name & Middle Initial & Last Name & Degree
Jamil Natour, PhD
Facility Name
Ambulatory at UNIFESP
City
São Paulo
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giovana Fernandes, Master
Phone
+55 11 84987581
Email
gifernandespersonal@hotmail.com
First Name & Middle Initial & Last Name & Degree
Giovana Fernandes, Mestranda

12. IPD Sharing Statement

Citations:
PubMed Identifier
26903145
Citation
Fernandes G, Jennings F, Nery Cabral MV, Pirozzi Buosi AL, Natour J. Swimming Improves Pain and Functional Capacity of Patients With Fibromyalgia: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2016 Aug;97(8):1269-75. doi: 10.1016/j.apmr.2016.01.026. Epub 2016 Feb 20.
Results Reference
derived

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Effects of Swimming in the Treatment of Fibromyalgia

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