NCT00146393

Brief Summary

The primary goal of this study is to assess the effect of People with Arthritis Can Exercise (PACE), a community-based group recreational exercise program, on key arthritis-related health outcomes among adults with arthritis.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
347

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2003

Shorter than P25 for phase_2

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
1.3 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
Last Updated

December 9, 2005

Status Verified

September 1, 2005

First QC Date

September 2, 2005

Last Update Submit

December 8, 2005

Conditions

Keywords

exercisephysical activityphysical conditioningpainphysical function

Outcome Measures

Primary Outcomes (4)

  • Visual Analog Scale pain level at baseline, 2, 3 and 6 months

  • Self-reported physical function (Health Assessment Questionnaire) at baseline, and 2, 3 and 6 months

  • Measured function (6 minute walk, 360 deg turn, walking speed and timed chair stands, 10 lb lift) at baseline and 2 months

  • Physical activity level (Physical Activity Scale for the Elderly : PASE) at baseline, 2, 3 and 6 months

Secondary Outcomes (8)

  • Visual analog scale fatigue

  • Visual analog scale stiffness

  • Rheumatoid Arthritis Self-efficacy Scale (RASE)

  • Center for Epidemiologic Studies Depression Scale (CES-D)

  • Outcomes Expectations for Exercise (OEE)

  • +3 more secondary outcomes

Interventions

Eligibility Criteria

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

You may qualify if:

  • Adults over age 18
  • Have some form of arthritis (examples: osteoarthritis, rheumatoid arthritis, lupus, fibromyalgia, gout, etc.)
  • Be able to move independently without assistance
  • Currently exercising less than 3 times per week

You may not qualify if:

  • Inability to walk without assistance
  • Severe health condition where exercise is contraindicated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Schoster B, Callahan LF, Meier A, Mielenz T, DiMartino L. The People with Arthritis Can Exercise (PACE) program: a qualitative evaluation of participant satisfaction. Prev Chronic Dis. 2005 Jul;2(3):A11. Epub 2005 Jun 15.

  • Callahan LF, Mielenz T, Freburger J, Shreffler J, Hootman J, Brady T, Buysse K, Schwartz T. A randomized controlled trial of the people with arthritis can exercise program: symptoms, function, physical activity, and psychosocial outcomes. Arthritis Rheum. 2008 Jan 15;59(1):92-101. doi: 10.1002/art.23239.

MeSH Terms

Conditions

ArthritisOsteoarthritisArthritis, RheumatoidMotor ActivityPain

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesBehaviorNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jennifer M Hootman, PhD

    Centers for Disease Control and Prevention

    STUDY CHAIR
  • Leigh 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

July 1, 2003

Study Completion

June 1, 2004

Last Updated

December 9, 2005

Record last verified: 2005-09