NCT01547195

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2012

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 7, 2012

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

March 30, 2012

Status Verified

March 1, 2012

Enrollment Period

Same day

First QC Date

February 21, 2012

Last Update Submit

March 28, 2012

Conditions

Fibromyalgia

Keywords

fibromyalgiaswimming

Outcome Measures

Primary Outcomes (1)

  • Diminishing of pain

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

    3 months

Secondary Outcomes (1)

  • Improving quality of life

    3 months

Study Arms (2)

Group-swimming

EXPERIMENTAL
Procedure: swim training

Control-walk

ACTIVE COMPARATOR
Procedure: Training walk

Interventions

swim trainingPROCEDURE

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.

Also known as: Swimming., Freestyle.
Group-swimming
Training walkPROCEDURE

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.

Also known as: Walk.
Control-walk

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ambulatory at UNIFESP

São Paulo, São Paulo, Brazil

RECRUITING

Universidade Federal de São Paulo

São Paulo, São Paulo, Brazil

RECRUITING

Related Publications (1)

  • 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.

    PMID: 26903145DERIVED

MeSH Terms

Conditions

Fibromyalgia

Interventions

SwimmingWalking

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

LocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Study Officials

  • Giovana Fernandes, Mestranda

    Universidade Federal de São Paulo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Giovana Fernandes, Mestranda

CONTACT

+55 11 25943375gifernandespersonal@hotmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
EVALUATION OF THE EFFECTS OF SWIMMING IN THE TREATMENT OF PATIENTS WITH FIBROMYALGIA

Study Record Dates

First Submitted

February 21, 2012

First Posted

March 7, 2012

Study Start

January 1, 2012

Primary Completion

January 1, 2012

Study Completion

December 1, 2012

Last Updated

March 30, 2012

Record last verified: 2012-03

Locations

BR(2)