NCT00146367

Brief Summary

The primary goal of this study is to assess the effectiveness and feasibility of the Active Living Every Day Physical Activity Program (ALED) for people with arthritis. This project is designed to evaluate the effectiveness of the ALED program in changing arthritis-related health outcomes and to investigate the feasibility of conducting the ALED program in a public health setting.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
355

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2004

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 2, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 7, 2005

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
Last Updated

September 14, 2005

Status Verified

September 1, 2005

First QC Date

September 2, 2005

Last Update Submit

September 12, 2005

Conditions

Arthritis

Keywords

arthritisosteoarthritisrheumatoid arthritisrheumatic diseaseexercisephysical activityphysical functiondisability

Outcome Measures

Primary Outcomes (2)

  • Physical Activity Level measured via CHAMPS instrument at baseline and 20 weeks

  • Physical Fitness Level measued via 2 minute step test at baseline and 20 weeks

Secondary Outcomes (5)

  • Functional status measured via HAQ at baseline and 20 weeks

  • Arthritis Self-efficacy measured at baseline and 20 weeks

  • Health-related Quality of Life measured at baseline, 20 weeks, 6 months and 12 months

  • Pain, fatigue and stiffness VAS at baseline and 20 weeks

  • Activities of Daily Living measured at baseline, 20 weeks, 6 months and 12 months

Interventions

Active Living Every DayBEHAVIORAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Self-reported arthritis or chronic joint symptoms
  • Currently exercising less than 3 times per week
  • Plan to be in community for at least 1 year
  • Physician release for participation in physical activity

You may not qualify if:

  • Pregnancy
  • Non-English speaking
  • Cognitive impairment
  • Serious medical condition where exercise is contradindicated
  • Severe physical or mental impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ArthritisOsteoarthritisArthritis, RheumatoidRheumatic DiseasesMotor Activity

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesBehavior

Study Officials

  • Jennifer M Hootman, PhD

    Centers for Disease Control and Prevention

    STUDY CHAIR

  • Leigh F Callahan, PhD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED

Study Record Dates

First Submitted

September 2, 2005

First Posted

September 7, 2005

Study Start

January 1, 2004

Study Completion

October 1, 2005

Last Updated

September 14, 2005

Record last verified: 2005-09