Evaluation of Walk With Ease in Arthritis

NCT00526435 | Completed Phase 3

• 2 other identifiers: CDC-NCCDPHP-AAMC-0975AAMC-0975
• Study Type: interventional
• Target: 468
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Arthritis

Keywords

Arthritis; osteoarthritis; rheumatoid arthritis; fibromyalgia; lupus

Outcome Measures

Primary Outcomes (4)

• Physical Activity Level

  6 weeks

• 6-minute walk

  6 weeks

• Walking behaviors

  6 weeks

• Exercise self-efficacy

  6 weeks

Secondary Outcomes (4)

• Health-related Quality of Life (SF36)

• Health Assessment Questionnaire

• Arthritis Symptoms

• Senior Fitness Test (function)

Study Arms (2)

Group WWE

EXPERIMENTAL

Subjects will participate in a group-assisted 6 week WWE program.

Behavioral: Walk with Ease - Group

Self-directed

EXPERIMENTAL

Subjects will follow the self-directed WWE program.

Behavioral: Walk with Ease - Self

Interventions

Walk with Ease - Group BEHAVIORAL

Participate in 6-week, 1 hour per week group assisted classes (with instructor).

Group WWE

Walk with Ease - Self BEHAVIORAL

SUbject will receive the WWE workbook and follow it without group/instructor assistance.

Self-directed

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Self-reported, doctor-diagnosed arthritis
• Ages 18+

You may not qualify if:

• Non-English speaking
• Severe impairment of physical or mental function
• Co-existing condition for which exercise is contraindicated

Sponsors & Collaborators

• Centers for Disease Control and Prevention: lead
• University of North Carolina, Chapel Hill: collaborator

Study Sites (1)

University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Arthritis; Osteoarthritis; Arthritis, Rheumatoid; Fibromyalgia

Interventions

Walking

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Muscular Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity

Study Officials

• Jennifer M Hootman, PhD

  Centers for Disease Control and Prevention

  STUDY DIRECTOR

• Leigh F Callahan, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED

Study Record Dates

• First Submitted: September 6, 2007
• First Posted: September 10, 2007
• Study Start: October 1, 2007
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: March 24, 2011

Record last verified: 2011-03

Locations

US (1)