Program Evaluation of People With Arthritis Can Exercise

Rheumatoid Arthritis Clinical Trial

Official title:

Evaluation of the Health Benefits of the People With Arthritis Can Exercise Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00153309
• Other study ID #: CDC-NCCDPHP-0507
• Secondary ID: CDC-NCCDPHP-MM-0
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 7, 2005
• Last updated: November 16, 2005
• Start date: June 2003
• Est. completion date: June 2005

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 purpose of this study is to evaluate the health and arthritis-specific benefits of participation in the Arthritis Foundation People with Arthritis Can Exercise program and to collect information to improve community-based dissemination of this program.

Description:

Only about 24% of people with arthritis report sufficient physical activity to provide general health benefits. Research has demonstrated that many people with arthritis can safely exercise to improve fitness and health. The People with Arthritis Can Exercise (PACE) program, developed by the Arthritis Foundation, is a land-based recreational physical activity and exercise program. PACE has been offered as a community-based program for over 10 years and small studies have reported benefits for people with arthritis. However, there has been no randomized controlled community trials that evaluate the effectiveness of PACE in the community. The goals of the Evaluation of PACE project are to: (1) appropriately evaluate the AF PACE exercise program, and (2) provide information to support effective content, recruitment and programming. Specific objectives for meeting these goals include:

1. Identify the theoretical foundations and constructs for evaluating the program and select and use appropriate outcome measures;

2. Plan and conduct a randomized controlled trial of 8 and 16 week PACE programs;

3. Perform a qualitative evaluation using focus groups of PACE instructors and participants;

4. Disseminate findings and make recommendations.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults age 18 and older

• Self-reported arthritis or chronic joint symptoms

• Community-dwelling

Exclusion Criteria:

• Serious medical conditions which would contraindicate exercise

• No severe physical or mental condition

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

Locations

Country	Name	City	State
United States	St. Louis University	St. Louis	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention	St. Louis University, University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical Activity Level - PASE instrument at baseline, 8 and 16 weeks.
Primary	Pain Visual Analog Scale - at baseline, 8 and 16 weeks
Primary	Physical Function using the Functional Fitness Battery at baseline, 8 and 16 weeks
Primary	Self-reported function (HAQ) at baseline, 8 and 16 weeks
Secondary	Health-related quality of life
Secondary	Disease status
Secondary	Self-efficacy for arthritis management
Secondary	Self-efficacy for exercise
Secondary	Social support
Secondary	Depressive symptoms
Secondary	Anxiety