Program Evaluation of People With Arthritis Can Exercise
Primary Purpose
Arthritis, Osteoarthritis, Rheumatoid Arthritis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
People with Arthritis Can Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Arthritis focused on measuring arthritis, exercise, physical activity, physical function, pain
Eligibility Criteria
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
Sites / Locations
- St. Louis University
Outcomes
Primary Outcome Measures
Physical Activity Level - PASE instrument at baseline, 8 and 16 weeks.
Pain Visual Analog Scale - at baseline, 8 and 16 weeks
Physical Function using the Functional Fitness Battery at baseline, 8 and 16 weeks
Self-reported function (HAQ) at baseline, 8 and 16 weeks
Secondary Outcome Measures
Health-related quality of life
Disease status
Self-efficacy for arthritis management
Self-efficacy for exercise
Social support
Depressive symptoms
Anxiety
Full Information
NCT ID
NCT00153309
First Posted
September 7, 2005
Last Updated
November 16, 2005
Sponsor
Centers for Disease Control and Prevention
Collaborators
University of Missouri-Columbia, St. Louis University
1. Study Identification
Unique Protocol Identification Number
NCT00153309
Brief Title
Program Evaluation of People With Arthritis Can Exercise
Official Title
Evaluation of the Health Benefits of the People With Arthritis Can Exercise Program
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Centers for Disease Control and Prevention
Collaborators
University of Missouri-Columbia, St. Louis University
4. Oversight
5. Study Description
Brief 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.
Detailed 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:
Identify the theoretical foundations and constructs for evaluating the program and select and use appropriate outcome measures;
Plan and conduct a randomized controlled trial of 8 and 16 week PACE programs;
Perform a qualitative evaluation using focus groups of PACE instructors and participants;
Disseminate findings and make recommendations.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Osteoarthritis, Rheumatoid Arthritis
Keywords
arthritis, exercise, physical activity, physical function, pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
People with Arthritis Can Exercise
Primary Outcome Measure Information:
Title
Physical Activity Level - PASE instrument at baseline, 8 and 16 weeks.
Title
Pain Visual Analog Scale - at baseline, 8 and 16 weeks
Title
Physical Function using the Functional Fitness Battery at baseline, 8 and 16 weeks
Title
Self-reported function (HAQ) at baseline, 8 and 16 weeks
Secondary Outcome Measure Information:
Title
Health-related quality of life
Title
Disease status
Title
Self-efficacy for arthritis management
Title
Self-efficacy for exercise
Title
Social support
Title
Depressive symptoms
Title
Anxiety
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer M Hootman, PhD
Organizational Affiliation
Centers for Disease Control and Prevention
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Marian Minor, PhD
Organizational Affiliation
University of Missouri-Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Louis University
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
12. IPD Sharing Statement
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Program Evaluation of People With Arthritis Can Exercise
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