Rheumatoid Arthritis Clinical Trial
Official title:
Evaluation of People With Arthritis Can Exercise
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.
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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