Progressive Resistance Training for Fibromyalgia

July 4, 2018 updated by: Anamaria Jones, Federal University of São Paulo

Evaluation of the Effectiveness of a Progressive Resistance Training Program for Patients With Fibromyalgia: a Randomized Controlled Trial

Patients in the experimental group underwent a progressive resistance training program, performed twice a week for 12 weeks. The charge intensity was progressively increased from 40% to 80% of 1 repetition maximum. The following muscle groups were worked: trunk flexors and extensors, elbow flexors and extensors, knee flexors and extensors, hip abductors and adductors and shoulder abductors. In addition to strength training, the experimental group also conducted a structured education program in one hour class once a week for five weeks. Patients in the control group performed the same education program.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of fibromyalgia according to the criteria of the American College of Rheumatology;
  • Feminine gender;
  • Age between 18 and 65 years;
  • Pain between 3 and 8 cm in the Numerical Pain Scale (END);
  • Have not changed treatment for fibromyalgia in the past three months;
  • Agree to participate in the study and sign the informed consent form.

Exclusion Criteria:

  • Cognitive deficit that does not allow the understanding of the evaluation instruments;
  • Other diseases that make it impossible to perform the exercises;
  • Physical activity started or changed in the last three months;
  • Physical therapy in the last six months;
  • In litigation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
Other: Progressive resistance training program
Progressive resistance training program were performed twice a week for 12 weeks. The charge intensity was progressively increased from 40% to 80% of 1 repetition maximum. The following muscle groups were worked: trunk flexors and extensors, elbow flexors and extensors, knee flexors and extensors, hip abductors and adductors and shoulder abductors. In addition to strength training.
Other: Educational Program
Structured education program were performed during one hour class once a week for five weeks
Active Comparator: Control Group
Other: Educational Program
Structured education program were performed during one hour class once a week for five weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pain
Time Frame: Baseline and after 6 and 12 weeks
Measured by numerical pain scale
Baseline and after 6 and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Health related quality of life
Time Frame: Baseline and after 6 and 12 weeks
Measured by Fibromyalgia Impact Questionnaire
Baseline and after 6 and 12 weeks
Change in Generic quality of life
Time Frame: Baseline and after 6 and 12 weeks
Measured by the Medical Outcome Survey Short Form 36
Baseline and after 6 and 12 weeks
Change in Functional capacity
Time Frame: Baseline and after 6 and 12 weeks
Measured by the 6-minute Walk Test
Baseline and after 6 and 12 weeks
Change in strength
Time Frame: Baseline and after 6 and 12 weeks
Measured by the 1 repetition maximum
Baseline and after 6 and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2016

Primary Completion (Actual)

September 2, 2017

Study Completion (Actual)

March 25, 2018

Study Registration Dates

First Submitted

July 4, 2018

First Submitted That Met QC Criteria

July 4, 2018

First Posted (Actual)

July 17, 2018

Study Record Updates

Last Update Posted (Actual)

July 17, 2018

Last Update Submitted That Met QC Criteria

July 4, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEP UNIFESP 482056

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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