Health Benefits of an Exercise Program for Adults With Arthritis

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. Identifier: NCT00146393
Recruitment Status : Completed
First Posted : September 7, 2005
Last Update Posted : December 9, 2005
University of North Carolina
Information provided by:
Centers for Disease Control and Prevention

Brief Summary:
The primary goal of this study is to assess the effect of People with Arthritis Can Exercise (PACE), a community-based group recreational exercise program, on key arthritis-related health outcomes among adults with arthritis.

Condition or disease Intervention/treatment Phase
Arthritis Osteoarthritis Rheumatoid Arthritis Behavioral: People with Arthritis Can Exercise program Phase 2 Phase 3

Detailed Description:

Self-management is very important in chronic diseases, and promoting physical activity is a key public health strategy for arthritis management. Although several exercise programs such as People with Arthritis Can Exercise (PACE) have been created to implement this strategy, none have sufficient scientific evidence supporting their effectiveness to promote the programs through public health avenues.

The primary goal of this study is to assess the effect of PACE(People with Arthritis Can Exercise), a community-based group recreational exercise program, on key arthritis-related health outcomes. The primary goal of the study will be accomplished through an eight week randomized controlled trial conducted with 480 participants residing in eight urban or rural communities in North Carolina. This project is designed to evaluate the effectiveness of the program in changing arthritis-related health outcomes such as pain, function and physical activity levels. The project will compare the eight week PACE program to a control group.

The specific objectives are as follows: (The aims have not been modified.)

  1. To further review the PACE conceptual framework and materials in order to develop a standardized PACE protocol to be delivered in the study as well as to refine study measures.
  2. To work closely with the Carolinas AF Chapter to develop collaborative relationships with local health departments and key contacts in communities identified for PACE implementation.
  3. To recruit 480 individuals to participate in a randomized controlled trial of PACE in eight communities and to implement the PACE program.
  4. To compare changes in key arthritis-related health outcomes between PACE participants and controls over eight weeks (PACE course time frame).
  5. To determine longer-term benefits of the PACE intervention by examining key arthritis-related health outcomes 3 and 6 months post completion of the intervention.
  6. To conduct qualitative research among PACE completers and non-completers to determine motivators and barriers to success, as well as to determine the acceptability and suitability of the program.
  7. To formulate recommendations or modifications for implementation of the PACE program.

Study Type : Interventional  (Clinical Trial)
Enrollment : 347 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of People With Arthritis Can Exercise
Study Start Date : July 2003
Study Completion Date : June 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Visual Analog Scale pain level at baseline, 2, 3 and 6 months
  2. Self-reported physical function (Health Assessment Questionnaire) at baseline, and 2, 3 and 6 months
  3. Measured function (6 minute walk, 360 deg turn, walking speed and timed chair stands, 10 lb lift) at baseline and 2 months
  4. Physical activity level (Physical Activity Scale for the Elderly : PASE) at baseline, 2, 3 and 6 months

Secondary Outcome Measures :
  1. Visual analog scale fatigue
  2. Visual analog scale stiffness
  3. Rheumatoid Arthritis Self-efficacy Scale (RASE)
  4. Center for Epidemiologic Studies Depression Scale (CES-D)
  5. Outcomes Expectations for Exercise (OEE)
  6. COnfidence Self-efficacy (CSE)
  7. Rheumatology Attitudes Index (RAI)
  8. Tampa Scale for Kinesiophobia (TSK)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adults over age 18
  • Have some form of arthritis (examples: osteoarthritis, rheumatoid arthritis, lupus, fibromyalgia, gout, etc.)
  • Be able to move independently without assistance
  • Currently exercising less than 3 times per week

Exclusion Criteria:

  • Inability to walk without assistance
  • Severe health condition where exercise is contraindicated

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00146393

Sponsors and Collaborators
Centers for Disease Control and Prevention
University of North Carolina
Study Chair: Jennifer M Hootman, PhD Centers for Disease Control and Prevention
Principal Investigator: Leigh Callahan, PhD University of North Carolina, Chapel Hill

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00146393     History of Changes
Other Study ID Numbers: CDC-NCCDPHP-0275
First Posted: September 7, 2005    Key Record Dates
Last Update Posted: December 9, 2005
Last Verified: September 2005

Keywords provided by Centers for Disease Control and Prevention:
physical activity
physical conditioning
physical function

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