Health Benefits of an Exercise Program for Adults With Arthritis
Primary Purpose
Arthritis, Osteoarthritis, Rheumatoid Arthritis
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
People with Arthritis Can Exercise program
Sponsored by
About this trial
This is an interventional treatment trial for Arthritis focused on measuring exercise, physical activity, physical conditioning, pain, physical function
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
Visual Analog Scale pain level at baseline, 2, 3 and 6 months
Self-reported physical function (Health Assessment Questionnaire) at baseline, and 2, 3 and 6 months
Measured function (6 minute walk, 360 deg turn, walking speed and timed chair stands, 10 lb lift) at baseline and 2 months
Physical activity level (Physical Activity Scale for the Elderly : PASE) at baseline, 2, 3 and 6 months
Secondary Outcome Measures
Visual analog scale fatigue
Visual analog scale stiffness
Rheumatoid Arthritis Self-efficacy Scale (RASE)
Center for Epidemiologic Studies Depression Scale (CES-D)
Outcomes Expectations for Exercise (OEE)
COnfidence Self-efficacy (CSE)
Rheumatology Attitudes Index (RAI)
Tampa Scale for Kinesiophobia (TSK)
Full Information
NCT ID
NCT00146393
First Posted
September 2, 2005
Last Updated
December 8, 2005
Sponsor
Centers for Disease Control and Prevention
Collaborators
University of North Carolina
1. Study Identification
Unique Protocol Identification Number
NCT00146393
Brief Title
Health Benefits of an Exercise Program for Adults With Arthritis
Official Title
Evaluation of People With Arthritis Can Exercise
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Centers for Disease Control and Prevention
Collaborators
University of North Carolina
4. Oversight
5. Study Description
Brief 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.
Detailed 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.)
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Osteoarthritis, Rheumatoid Arthritis
Keywords
exercise, physical activity, physical conditioning, pain, physical function
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
347 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
People with Arthritis Can Exercise program
Primary Outcome Measure Information:
Title
Visual Analog Scale pain level at baseline, 2, 3 and 6 months
Title
Self-reported physical function (Health Assessment Questionnaire) at baseline, and 2, 3 and 6 months
Title
Measured function (6 minute walk, 360 deg turn, walking speed and timed chair stands, 10 lb lift) at baseline and 2 months
Title
Physical activity level (Physical Activity Scale for the Elderly : PASE) at baseline, 2, 3 and 6 months
Secondary Outcome Measure Information:
Title
Visual analog scale fatigue
Title
Visual analog scale stiffness
Title
Rheumatoid Arthritis Self-efficacy Scale (RASE)
Title
Center for Epidemiologic Studies Depression Scale (CES-D)
Title
Outcomes Expectations for Exercise (OEE)
Title
COnfidence Self-efficacy (CSE)
Title
Rheumatology Attitudes Index (RAI)
Title
Tampa Scale for Kinesiophobia (TSK)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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 Chair
First Name & Middle Initial & Last Name & Degree
Leigh Callahan, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
15963313
Citation
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.
Results Reference
result
PubMed Identifier
18163409
Citation
Callahan LF, Mielenz T, Freburger J, Shreffler J, Hootman J, Brady T, Buysse K, Schwartz T. A randomized controlled trial of the people with arthritis can exercise program: symptoms, function, physical activity, and psychosocial outcomes. Arthritis Rheum. 2008 Jan 15;59(1):92-101. doi: 10.1002/art.23239.
Results Reference
derived
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Health Benefits of an Exercise Program for Adults With Arthritis
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