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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
Centers for Disease Control and Prevention
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis focused on measuring exercise, physical activity, physical conditioning, pain, physical function

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    September 2, 2005
    Last Updated
    December 8, 2005
    Sponsor
    Centers for Disease Control and Prevention
    Collaborators
    University of North Carolina
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    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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