Evaluation of Walk With Ease in Arthritis - Full Text View

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 Behavioral: Control	Phase III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Double Blind (Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

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)

Estimated Enrollment:	657
Study Start Date:	October 2007
Estimated Study Completion Date:	October 2009

Arms	Assigned Interventions
Group WWE: Experimental 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).
Self-directed: Experimental 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.
Control: Placebo Comparator Subjects will continue with usual activities.	Behavioral: Control SUbjects will do no specific intervention, continue usual activities.

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

Contacts


Contact: Leigh F Callahan, PhD	919-966-0564	leigh_callahan@med.unc.edu

Contact: Katherine Buysse	919-966-0574	buysse@email.unc.edu

Locations


United States, North Carolina
	University of North Carolina - Chapel Hill	Not yet recruiting
	Chapel Hill, North Carolina, United States, 27599

Sponsors and Collaborators

Centers for Disease Control and Prevention

University of North Carolina

Investigators


Study Director:	Jennifer M Hootman, PhD	Centers for Disease Control and Prevention

Principal Investigator:	Leigh F Callahan, PhD	The University of North Carolina, Chapel Hill

More Information

Study ID Numbers:	CDC-NCCDPHP-AAMC-0975, AAMC-0975
First Received:	September 6, 2007
Last Updated:	September 6, 2007
ClinicalTrials.gov Identifier:	NCT00526435
Health Authority:	United States: Federal Government

Keywords provided by Centers for Disease Control and Prevention:

Arthritis

osteoarthritis

rheumatoid arthritis

fibromyalgia

lupus

Study placed in the following topic categories:

Musculoskeletal Diseases

Myofascial Pain Syndromes

Fibromyalgia

Osteoarthritis

Joint Diseases

Arthritis

Arthritis, Rheumatoid

ClinicalTrials.gov processed this record on October 16, 2008

Sponsors and Collaborators:	Centers for Disease Control and Prevention University of North Carolina
Information provided by:	Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:	NCT00526435