Health Benefits of an Exercise Program for Adults With Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

Evaluation of People With Arthritis Can Exercise

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00146393
• Other study ID #: CDC-NCCDPHP-0275
• Secondary ID: CDC-PEP-MM0275
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 2, 2005
• Last updated: December 8, 2005
• Start date: July 2003
• Est. completion date: June 2004

Study information

• Verified date: September 2005
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 347
• Est. completion date: June 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Osteoarthritis
• Rheumatoid Arthritis

Intervention

Behavioral:
• People with Arthritis Can Exercise program

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention	University of North Carolina

References & Publications (1)

Schoster B, Callahan LF, Meier A, Mielenz T, DiMartino L. The People with Arthritis Can Exercise (PACE) program: a qualitative evaluation of participant satisfaction. Prev Chronic Dis. 2005 Jul;2(3):A11. Epub 2005 Jun 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale pain level at baseline, 2, 3 and 6 months
Primary	Self-reported physical function (Health Assessment Questionnaire) at baseline, and 2, 3 and 6 months
Primary	Measured function (6 minute walk, 360 deg turn, walking speed and timed chair stands, 10 lb lift) at baseline and 2 months
Primary	Physical activity level (Physical Activity Scale for the Elderly : PASE) at baseline, 2, 3 and 6 months
Secondary	Visual analog scale fatigue
Secondary	Visual analog scale stiffness
Secondary	Rheumatoid Arthritis Self-efficacy Scale (RASE)
Secondary	Center for Epidemiologic Studies Depression Scale (CES-D)
Secondary	Outcomes Expectations for Exercise (OEE)
Secondary	COnfidence Self-efficacy (CSE)
Secondary	Rheumatology Attitudes Index (RAI)
Secondary	Tampa Scale for Kinesiophobia (TSK)