Evaluation of Walk With Ease in Arthritis (WWE)
This study has been completed.
Sponsor:
Collaborator:
University of North Carolina, Chapel Hill
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00526435
First received: September 6, 2007
Last updated: March 23, 2011
Last verified: March 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Arthritis |
Behavioral: Walk with Ease - Group Behavioral: Walk with Ease - Self |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Evaluation of the Walk With Ease Program Among People With Arthritis |
Further study details as provided by Centers for Disease Control and Prevention:
Primary Outcome Measures:
- Physical Activity Level [ Time Frame: 6 weeks ]
- 6-minute walk [ Time Frame: 6 weeks ]
- Walking behaviors [ Time Frame: 6 weeks ]
- Exercise self-efficacy [ Time Frame: 6 weeks ]
Secondary Outcome Measures:
- Health-related Quality of Life (SF36)
- Health Assessment Questionnaire
- Arthritis Symptoms
- Senior Fitness Test (function)
| Enrollment: | 468 |
| Study Start Date: | October 2007 |
| Study Completion Date: | January 2010 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group WWE
Subjects will participate in a group-assisted 6 week WWE program.
|
Behavioral: Walk with Ease - Group
Participate in 6-week, 1 hour per week group assisted classes (with instructor).
|
|
Experimental: Self-directed
Subjects will follow the self-directed WWE program.
|
Behavioral: Walk with Ease - Self
SUbject will receive the WWE workbook and follow it without group/instructor assistance.
|
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00526435
Locations
| United States, North Carolina | |
| University of North Carolina - Chapel Hill | |
| Chapel Hill, North Carolina, United States, 27599 | |
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
| Study Director: | Jennifer M Hootman, PhD | Centers for Disease Control and Prevention |
| Principal Investigator: | Leigh F Callahan, PhD | University of North Carolina, Chapel Hill |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00526435 History of Changes |
| Other Study ID Numbers: | CDC-NCCDPHP-AAMC-0975, AAMC-0975 |
| Study First Received: | September 6, 2007 |
| Last Updated: | March 23, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by Centers for Disease Control and Prevention:
|
Arthritis osteoarthritis rheumatoid arthritis fibromyalgia lupus |
Additional relevant MeSH terms:
|
Arthritis Joint Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on May 21, 2013