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
  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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 02, 2014