Health Benefits of an Exercise Program for Adults With Arthritis

This study has been completed.
Sponsor:
Collaborator:
University of North Carolina
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00146393
First received: September 2, 2005
Last updated: December 8, 2005
Last verified: September 2005
  Purpose

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 Intervention Phase
Arthritis
Osteoarthritis
Rheumatoid Arthritis
Behavioral: People with Arthritis Can Exercise program
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of People With Arthritis Can Exercise

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

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

Secondary Outcome Measures:
  • Visual analog scale fatigue
  • Visual analog scale stiffness
  • Rheumatoid Arthritis Self-efficacy Scale (RASE)
  • Center for Epidemiologic Studies Depression Scale (CES-D)
  • Outcomes Expectations for Exercise (OEE)
  • COnfidence Self-efficacy (CSE)
  • Rheumatology Attitudes Index (RAI)
  • Tampa Scale for Kinesiophobia (TSK)

Estimated Enrollment: 347
Study Start Date: July 2003
Estimated Study Completion Date: June 2004
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00146393

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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00146393     History of Changes
Other Study ID Numbers: CDC-NCCDPHP-0275, CDC-PEP-MM0275
Study First Received: September 2, 2005
Last Updated: December 8, 2005
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on August 28, 2014