Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00792675
Recruitment Status : Completed
First Posted : November 18, 2008
Last Update Posted : November 18, 2008
Sponsor:
Collaborators:
Arthritis Foundation
UNMC and The Nebraska Medical Center, Research Support Fund
Information provided by:
University of Nebraska

Tracking Information
First Submitted Date  ICMJE November 17, 2008
First Posted Date  ICMJE November 18, 2008
Last Update Posted Date November 18, 2008
Study Start Date  ICMJE January 2003
Actual Primary Completion Date April 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 17, 2008)
  • Swollen Joint Count [ Time Frame: 12 Weeks ]
  • Tender Joint Count [ Time Frame: 12 Weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2008)
  • Pain (visual Analog Scale) [ Time Frame: 12 Weeks ]
  • Modified-Health Assessment Questionnaire [ Time Frame: 12 Weeks ]
  • Estimated Aerobic Capacity (VO2max) [ Time Frame: 12 weeks ]
  • SF-36 [ Time Frame: 12 Weeks ]
  • Patient Global Assessment [ Time Frame: 12 Weeks ]
  • Practitioner Global Assessment [ Time Frame: 12 Weeks ]
  • Timed-Stands Test [ Time Frame: 12 Weeks ]
  • 50 Foot Walk Test [ Time Frame: 12 Weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Exercise on the Disease Activity of Rheumatoid Arthritis
Official Title  ICMJE Not Provided
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Exercise
Intervention: Other: Aerobic and resistance exercise training
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 17, 2008)
55
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2007
Actual Primary Completion Date April 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00792675
Other Study ID Numbers  ICMJE 267-02-FB
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Laura D. Bilek, PhD, PT, Division of Physical Therapy Education, UNMC
Study Sponsor  ICMJE University of Nebraska
Collaborators  ICMJE
  • Arthritis Foundation
  • UNMC and The Nebraska Medical Center, Research Support Fund
Investigators  ICMJE Not Provided
PRS Account University of Nebraska
Verification Date November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP