Progressive Resistance Exercise in Rheumatoid Arthritis

August 12, 2016 updated by: Felipe Martinelli Lourenzi, Federal University of São Paulo

Progressive Resistance Exercise in Rheumatoid Arthritis Patients: a Randomized Controlled Trial

A randomized controlled trial with rheumatoid arthritis patients will be realized. Patients will be randomized into two groups. Experimental group will do a 12 weeks training of progressive resistance exercise for global muscles and remain with the clinical treatment and the control only remain with the clinical treatment. Patients will be evaluated at baseline, after 6, 12 and 24 weeks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Sao Paulo, SP, Brazil, 04023-900
        • Universidade Federal de São Paulo

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Rheumatoid arthritis according to American College of Rheumatology 2010
  • Both genders
  • Age between 18 and 65 years
  • Functional class I, II and III
  • Stable medication within the three months preceding the study
  • Haven't done any kind of regular exercise (two or more times per Week) for at least three months before study start
  • Have agreed to participate in the study and signed an informed consent form.

Exclusion Criteria:

  • Participating in another type of study
  • Have difficulty understanding the evaluation tools with fibromyalgia
  • Joint deformities that make impossible do the exercises
  • Other musculoskeletal diseases
  • Other diseases that contraindicate exercises.

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
Active Comparator: Control group
Patient remain with their usual clinical treatment.
Other: Control group
Other Names:
  • Clinical tretament
Experimental: Experimental group

Patients in experimental group participated in a 12-week progressive resistance training using a maximum repetition exercise in which patients performed 1 Maximum Repetition with the maximum bearable weight. Once the 1 Maximum Repetitionwas determined, training was divided into the following regimen: 2 series of 8 repetitions, the first with 50% and the second with 70% of 1 Maximum Repetition.

The exercises were knee extension and flexion and hip abduction and adduction, elbow extension and flexion, wrist extension and flexion and shoulder abduction and adduction and spine extension and flexion all performed in machines. The 1 Maximum Repetition load was reevaluated every 6 weeks.

Patient remain with their usual clinical treatment.
Other: Control group
Other Names:
  • Clinical tretament
Other: Experimental group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in pain - Visual analogue scale
Time Frame: baseline, 6, 12 and 24 weeks
baseline, 6, 12 and 24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in function capacity - Health Assessment questionaire
Time Frame: Baseline, after 6, 12 and 24 weeks
Baseline, after 6, 12 and 24 weeks
Change in quality of life - Short form 36
Time Frame: baseline, after 6, 12 and 24 weeks
baseline, after 6, 12 and 24 weeks
Change in strength - 1 maximum repetition
Time Frame: baseline, after 6, 12 and 24 weeks
baseline, after 6, 12 and 24 weeks

Collaborators and Investigators

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

Sponsor

Federal University of São Paulo

Collaborators

Fundação de Amparo à Pesquisa do Estado de 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

July 1, 2011

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

August 13, 2014

First Submitted That Met QC Criteria

August 14, 2014

First Posted (Estimate)

August 18, 2014

Study Record Updates

Last Update Posted (Estimate)

August 15, 2016

Last Update Submitted That Met QC Criteria

August 12, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEP/UNIFESP 1826/10

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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