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

This study has been completed.
Sponsor:
Collaborators:
Arthritis Foundation
UNMC and The Nebraska Medical Center, Research Support Fund
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT00792675
First received: November 17, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted
  Purpose

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.


Condition Intervention
Rheumatoid Arthritis
 Other: Aerobic and resistance exercise training

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • Swollen Joint Count [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Tender Joint Count [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain (visual Analog Scale) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Modified-Health Assessment Questionnaire [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Estimated Aerobic Capacity (VO2max) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • SF-36 [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Patient Global Assessment [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Practitioner Global Assessment [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Timed-Stands Test [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • 50 Foot Walk Test [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Enrollment: 55
Study Start Date: January 2003
Study Completion Date: November 2007
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise 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.

  Eligibility

Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00792675

Locations
United States, Nebraska
Division of Physical Therapy Education Physical Activity Lab
Omaha, Nebraska, United States, 69189-4420
Sponsors and Collaborators
University of Nebraska
Arthritis Foundation
UNMC and The Nebraska Medical Center, Research Support Fund
  More Information

No publications provided

Responsible Party: Laura D. Bilek, PhD, PT, Division of Physical Therapy Education, UNMC
ClinicalTrials.gov Identifier: NCT00792675     History of Changes
Other Study ID Numbers: 267-02-FB
Study First Received: November 17, 2008
Last Updated: November 17, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Nebraska:
exercise
disease activity
inflammation
resistance training
rehabilitation

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on June 18, 2013