- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00526435
Evaluation of Walk With Ease in Arthritis (WWE)
March 23, 2011 updated by: Centers for Disease Control and Prevention
Evaluation of the Walk With Ease Program Among People With Arthritis
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
468
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- University of North Carolina - Chapel Hill
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group WWE
Subjects will participate in a group-assisted 6 week WWE program.
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Participate in 6-week, 1 hour per week group assisted classes (with instructor).
|
|
Experimental: Self-directed
Subjects will follow the self-directed WWE program.
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SUbject will receive the WWE workbook and follow it without group/instructor assistance.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Physical Activity Level
Time Frame: 6 weeks
|
6 weeks
|
|
6-minute walk
Time Frame: 6 weeks
|
6 weeks
|
|
Walking behaviors
Time Frame: 6 weeks
|
6 weeks
|
|
Exercise self-efficacy
Time Frame: 6 weeks
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
|---|
|
Health Assessment Questionnaire
|
|
Health-related Quality of Life (SF36)
|
|
Arthritis Symptoms
|
|
Senior Fitness Test (function)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Jennifer M Hootman, PhD, Centers for Disease Control and Prevention
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2007
Primary Completion (Actual)
January 1, 2010
Study Completion (Actual)
January 1, 2010
Study Registration Dates
First Submitted
September 6, 2007
First Submitted That Met QC Criteria
September 6, 2007
First Posted (Estimate)
September 10, 2007
Study Record Updates
Last Update Posted (Estimate)
March 24, 2011
Last Update Submitted That Met QC Criteria
March 23, 2011
Last Verified
March 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDC-NCCDPHP-AAMC-0975
- AAMC-0975
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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