Effect of Exercise on the Disease Activity of Rheumatoid Arthritis (RA&Ex)

August 28, 2023 updated by: University of Nebraska

Evaluation of the Effect of Exercise on Disease Activity and Immune Parameters in Persons With Rheumatoid Arthritis

This study will evaluate the effect of exercise on the number of swollen and tender joints associated with rheumatoid arthritis after a 12 week exercise program of treadmill walking and weightlifting.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The goal of this study was to evaluate the effect of exercise on the number of swollen and tender joints associated with rheumatoid arthritis. It was hypothesized that persons would have less inflammation associated with rheumatoid arthritis after a 12 week exercise program of treadmill walking and weighlifting. Immune parameters were measured to determine potential mechanisms responsible for changes in inflammation with exercise.

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Not Applicable

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

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 69189-4420
        • Physical Activity Lab, University of Nebraska Omaha

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

19 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • a diagnosis of RA according to the ACR 1989 Criteria at least 6 months prior to enrollment in the study, but not longer than 12 years
  • age 19 to 65 years old
  • stable regimen of medication for 2 months with less than 10 mg/day of oral corticosteroids
  • currently exercise < 2x/week for less than 30 minutes at less than 60% of his/her age predicted maximum heart rate
  • Subjects must pass the Physical Activity Readiness Scale Questionnaire (PAR-Q)

Exclusion Criteria:

  • other serious health problems
  • intra-articular injection within 6 weeks
  • total joint replacement of the large joints
  • use of beta-blockers
  • inability to complete the submaximal exercise test

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise
Exercise consists of 30 minutes of treadmill exercise at approximately 85% of heart rate max and 2 sets of 6 resistance weight lifting exercises resulting in volitional fatigue at 12 to 15 repetitions.
Other: Aerobic and resistance exercise training
Exercise was performed 3 times per week. It consisted of 30 minutes of treadmill exercise at approximately 85% of heartrate max and 2 sets of 6 resistance weight lifting exercises resulting in volitional fatigue at 12 to 15 repetitions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Swollen Joint Count
Time Frame: 12 Weeks
12 Weeks
Tender Joint Count
Time Frame: 12 Weeks
12 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
SF-36
Time Frame: 12 Weeks
12 Weeks
Pain (visual Analog Scale)
Time Frame: 12 Weeks
12 Weeks
Modified-Health Assessment Questionnaire
Time Frame: 12 Weeks
12 Weeks
Estimated Aerobic Capacity (VO2max)
Time Frame: 12 weeks
12 weeks
Patient Global Assessment
Time Frame: 12 Weeks
12 Weeks
Practitioner Global Assessment
Time Frame: 12 Weeks
12 Weeks
Timed-Stands Test
Time Frame: 12 Weeks
12 Weeks
50 Foot Walk Test
Time Frame: 12 Weeks
12 Weeks

Collaborators and Investigators

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

Sponsor

University of Nebraska

Collaborators

Arthritis Foundation
Nebraska Chapter Arthritis Foundation

Investigators

  • Principal Investigator: Laura D Bilek, PhD, PT, University of Nebraska

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)

January 1, 2003

Primary Completion (Actual)

April 1, 2006

Study Completion (Actual)

November 1, 2006

Study Registration Dates

First Submitted

November 17, 2008

First Submitted That Met QC Criteria

November 17, 2008

First Posted (Estimated)

November 18, 2008

Study Record Updates

Last Update Posted (Actual)

August 30, 2023

Last Update Submitted That Met QC Criteria

August 28, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0267-02-FB

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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