Evaluation of Walk With Ease in Arthritis (WWE)
Primary Purpose
Arthritis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Walk with Ease - Group
Walk with Ease - Self
Sponsored by
About this trial
This is an interventional treatment trial for Arthritis focused on measuring Arthritis, osteoarthritis, rheumatoid arthritis, fibromyalgia, lupus
Eligibility Criteria
Inclusion Criteria:
- Self-reported, doctor-diagnosed arthritis
- Ages 18+
Exclusion Criteria:
- Non-English speaking
- Severe impairment of physical or mental function
- Co-existing condition for which exercise is contraindicated
Sites / Locations
- University of North Carolina - Chapel Hill
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group WWE
Self-directed
Arm Description
Subjects will participate in a group-assisted 6 week WWE program.
Subjects will follow the self-directed WWE program.
Outcomes
Primary Outcome Measures
Physical Activity Level
6-minute walk
Walking behaviors
Exercise self-efficacy
Secondary Outcome Measures
Health-related Quality of Life (SF36)
Health Assessment Questionnaire
Arthritis Symptoms
Senior Fitness Test (function)
Full Information
NCT ID
NCT00526435
First Posted
September 6, 2007
Last Updated
March 23, 2011
Sponsor
Centers for Disease Control and Prevention
Collaborators
University of North Carolina, Chapel Hill
1. Study Identification
Unique Protocol Identification Number
NCT00526435
Brief Title
Evaluation of Walk With Ease in Arthritis
Acronym
WWE
Official Title
Evaluation of the Walk With Ease Program Among People With Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Centers for Disease Control and Prevention
Collaborators
University of North Carolina, Chapel Hill
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The overall goal of this study is to determine the whether the Walk with Ease (WWE) program in its 2 version (group-assisted and self-directed) can increase physical activity and fitness levels among individuals (18 years and older) with arthritis over the long-term. Participants will be approximately 657 subjects from 20-24 rural and urban communities across North Carolina. It is expected that participants in the WWE program will have reduced pain, improved function and increased activity levels after participation in this 6-week program.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis
Keywords
Arthritis, osteoarthritis, rheumatoid arthritis, fibromyalgia, lupus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
468 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group WWE
Arm Type
Experimental
Arm Description
Subjects will participate in a group-assisted 6 week WWE program.
Arm Title
Self-directed
Arm Type
Experimental
Arm Description
Subjects will follow the self-directed WWE program.
Intervention Type
Behavioral
Intervention Name(s)
Walk with Ease - Group
Intervention Description
Participate in 6-week, 1 hour per week group assisted classes (with instructor).
Intervention Type
Behavioral
Intervention Name(s)
Walk with Ease - Self
Intervention Description
SUbject will receive the WWE workbook and follow it without group/instructor assistance.
Primary Outcome Measure Information:
Title
Physical Activity Level
Time Frame
6 weeks
Title
6-minute walk
Time Frame
6 weeks
Title
Walking behaviors
Time Frame
6 weeks
Title
Exercise self-efficacy
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Health-related Quality of Life (SF36)
Title
Health Assessment Questionnaire
Title
Arthritis Symptoms
Title
Senior Fitness Test (function)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Self-reported, doctor-diagnosed arthritis
Ages 18+
Exclusion Criteria:
Non-English speaking
Severe impairment of physical or mental function
Co-existing condition for which 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 Director
First Name & Middle Initial & Last Name & Degree
Leigh F Callahan, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina - Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
12. IPD Sharing Statement
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Evaluation of Walk With Ease in Arthritis
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