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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00526435
Other study ID # CDC-NCCDPHP-AAMC-0975
Secondary ID AAMC-0975
Status Completed
Phase Phase 3
First received September 6, 2007
Last updated March 23, 2011
Start date October 2007
Est. completion date January 2010

Study information

Verified date March 2011
Source Centers for Disease Control and Prevention
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 468
Est. completion date January 2010
Est. primary completion date January 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Walk with Ease - Group
Participate in 6-week, 1 hour per week group assisted classes (with instructor).
Walk with Ease - Self
SUbject will receive the WWE workbook and follow it without group/instructor assistance.

Locations

Country Name City State
United States University of North Carolina - Chapel Hill Chapel Hill North Carolina

Sponsors (2)

Lead Sponsor Collaborator
Centers for Disease Control and Prevention University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Physical Activity Level 6 weeks
Primary 6-minute walk 6 weeks
Primary Walking behaviors 6 weeks
Primary Exercise self-efficacy 6 weeks
Secondary Health-related Quality of Life (SF36)
Secondary Health Assessment Questionnaire
Secondary Arthritis Symptoms
Secondary Senior Fitness Test (function)
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