Evaluation of Walk With Ease in Arthritis | NCT00526435

Studies
Evaluation of Walk With Ease in Arthritis

NCT00526435

Sponsor

Centers for Disease Control and Prevention

Status

Completed

Last Update Posted

Mar 24, 2011Estimated

Enrollment

468Actual

Phase

Phase 3

Conditions

Arthritis

Interventions

Walk with Ease - Group
Walk with Ease - Self

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
AAMC-0975

Status Module

Record Verification Date

Mar 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2007

Primary Completion Date

Jan 2010Actual

Completion Date

Jan 2010Actual

First Submitted Date

Sep 6, 2007

First Submission Date that Met QC Criteria

Sep 6, 2007

First Posted Date

Sep 10, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 23, 2011

Last Update Posted Date

Mar 24, 2011Estimated

Name	Class
University of North Carolina, Chapel Hill	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

468Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Walk with Ease - Group	Behavioral	Participate in 6-week, 1 hour per week group assisted classes (with instructor).	Group WWE

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Physical Activity Level		6 weeks
6-minute walk		6 weeks
Walking behaviors		6 weeks
Exercise self-efficacy		6 weeks

Secondary Outcomes

Measure	Description	Time Frame
Health-related Quality of Life (SF36)
Health Assessment Questionnaire
Arthritis Symptoms

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jennifer M Hootman, PhD	Centers for Disease Control and Prevention	Study Director
Leigh F Callahan, PhD	University of North Carolina, Chapel Hill	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of North Carolina - Chapel Hill		Chapel Hill	North Carolina	27599	United States

Condition Browse Module

MeSH Terms

ID	Term
D001168	Arthritis
D010003	Osteoarthritis
D001172	Arthritis, Rheumatoid
D005356	Fibromyalgia

Ancestor Terms

ID	Term
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D003240	Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016138	Walking

Ancestor Terms

ID	Term
D008124	Locomotion
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided