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Completed

NCT Number: NCT00146393

Health Benefits of an Exercise Program for Adults With Arthritis

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.

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Key information

Conditions

Arthritis Arthritis, Rheumatoid Autoimmune Diseases Behavior Connective Tissue Diseases Immune System Diseases Joint Diseases Motor Activity Musculoskeletal Diseases Neurologic Manifestations Osteoarthritis Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Rheumatoid Arthritis Signs and Symptoms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

About this study

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.)

  • 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.
  • 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.
  • To recruit 480 individuals to participate in a randomized controlled trial of PACE in eight communities and to implement the PACE program.
  • To compare changes in key arthritis-related health outcomes between PACE participants and controls over eight weeks (PACE course time frame).
  • 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.
  • 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.
  • To formulate recommendations or modifications for implementation of the PACE program.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

People with Arthritis Can Exercise program

Behavioral

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Centers for Disease Control and Prevention

Fed

Collaborators

  • University of North Carolina

Registry information

Official study title

Evaluation of People With Arthritis Can Exercise

Important dates

Study start
2003
Study completion
2004
First posted
Sep 7, 2005
Registry last updated
Dec 9, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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