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Strengthening Exercises for Fibromyalgia

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
strengthening exercises using a Swiss ball
strengthening exercises
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, Muscle strength exercises, Pain, Quality of life

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • female with fibromyalgia according to the classification criteria of the American College of Rheumatology;
  • aged between 20 and 65 years old.

Exclusion Criteria:

  • uncontrolled hypertension;
  • decompensated cardiac disease;
  • history of syncope or exercise-induced arrhythmias and decompensated diabetes;
  • severe psychiatric illness;
  • history of regular exercise at least twice a week for the last 6 months;
  • any other condition that could prevent the patient from performing physical exercises.

Sites / Locations

  • Universidade Federal de Sao Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Strengthening group

Stretching group

Arm Description

This group perform muscle strengthening exercises using a Swiss ball of 65 cm diameter.

Performed stretching exercises

Outcomes

Primary Outcome Measures

Changes in Pain - VAS

Secondary Outcome Measures

Changes in quality of life - Fibromyalgia Impact Questionnaire (FIQ) questionnaire
Changes in muscle strength using the maximum repetition (1 RM)
Changes in consumption of analgesics

Full Information

First Posted
February 12, 2014
Last Updated
February 13, 2014
Sponsor
Federal University of São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02063750
Brief Title
Strengthening Exercises for Fibromyalgia
Official Title
Effectiveness of Strengthening Exercises Using the Swiss Ball for Patients With Fibromyalgia: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Objective: We evaluated the effectiveness of strengthening exercises using the Swiss ball in patients with fibromyalgia (FM). Material and Method: Sixty FM patients were randomized into two groups: an intervention group (IG), in which patients performed muscle strength exercises using the Swiss ball, and a stretching group (SG), in which patients performed stretching exercises. All patients participated in 40-minute training sessions three times per week for 12 weeks. The IG performed the following eight strengthening exercises using a Swiss ball: lateral rise, simultaneous biceps curl, squat, two arms triceps extension, abdominal, one arm dumbbell row, reverse crucifix and crucifix. The SG performed exercises targeting the same muscle groups trained in IG. Outcome measures were as follows: visual analogue scale (VAS) for pain, 1 repetition maximum test for muscle strength; fibromyalgia impact questionnaire (FIQ) to evaluate disease impact, and short form health survey (SF-36) to assess quality of life. All participants underwent an evaluation at baseline, at 6 weeks and at 12 weeks of training. The assessor was blind to patient allocation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Fibromyalgia, Muscle strength exercises, Pain, Quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Strengthening group
Arm Type
Experimental
Arm Description
This group perform muscle strengthening exercises using a Swiss ball of 65 cm diameter.
Arm Title
Stretching group
Arm Type
Active Comparator
Arm Description
Performed stretching exercises
Intervention Type
Other
Intervention Name(s)
strengthening exercises using a Swiss ball
Intervention Description
This group performed eight muscle strengthening exercises using a Swiss ball of 65 cm diameter and dumbbells with different loads. Each training session was 40 minutes long and was performed three times a week for 12 weeks. The exercises were performed in three sets of 12 repetitions, with an interval of one to two minutes of recovery between exercises, which alternated between upper limbs, lower limbs and abdomen. The load used was 60 % of one repetition maximum (1RM).
Intervention Type
Other
Intervention Name(s)
strengthening exercises
Intervention Description
The stretching group performed stretching exercises that targeted the same muscles trained in the IG. The participants remained in the stretched position for three sets of 30 s for each exercise. The total session time was 40 minutes.
Primary Outcome Measure Information:
Title
Changes in Pain - VAS
Time Frame
Basline, after 6 and 12 weeks
Secondary Outcome Measure Information:
Title
Changes in quality of life - Fibromyalgia Impact Questionnaire (FIQ) questionnaire
Time Frame
Baseline, after 6 and 12 weeks
Title
Changes in muscle strength using the maximum repetition (1 RM)
Time Frame
Baseline, after 6 and 12 weeks
Title
Changes in consumption of analgesics
Time Frame
After 6 and 12 weeks from baseline

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: female with fibromyalgia according to the classification criteria of the American College of Rheumatology; aged between 20 and 65 years old. Exclusion Criteria: uncontrolled hypertension; decompensated cardiac disease; history of syncope or exercise-induced arrhythmias and decompensated diabetes; severe psychiatric illness; history of regular exercise at least twice a week for the last 6 months; any other condition that could prevent the patient from performing physical exercises.
Facility Information:
Facility Name
Universidade Federal de Sao Paulo
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04023-090
Country
Brazil

12. IPD Sharing Statement

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Strengthening Exercises for Fibromyalgia

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