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Program Evaluation of People With Arthritis Can Exercise

Primary Purpose

Arthritis, Osteoarthritis, Rheumatoid Arthritis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
People with Arthritis Can Exercise
Sponsored by
Centers for Disease Control and Prevention
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis focused on measuring arthritis, exercise, physical activity, physical function, pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adults age 18 and older Self-reported arthritis or chronic joint symptoms Community-dwelling Exclusion Criteria: Serious medical conditions which would contraindicate exercise No severe physical or mental condition

Sites / Locations

  • St. Louis University

Outcomes

Primary Outcome Measures

Physical Activity Level - PASE instrument at baseline, 8 and 16 weeks.
Pain Visual Analog Scale - at baseline, 8 and 16 weeks
Physical Function using the Functional Fitness Battery at baseline, 8 and 16 weeks
Self-reported function (HAQ) at baseline, 8 and 16 weeks

Secondary Outcome Measures

Health-related quality of life
Disease status
Self-efficacy for arthritis management
Self-efficacy for exercise
Social support
Depressive symptoms
Anxiety

Full Information

First Posted
September 7, 2005
Last Updated
November 16, 2005
Sponsor
Centers for Disease Control and Prevention
Collaborators
University of Missouri-Columbia, St. Louis University
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1. Study Identification

Unique Protocol Identification Number
NCT00153309
Brief Title
Program Evaluation of People With Arthritis Can Exercise
Official Title
Evaluation of the Health Benefits of the People With Arthritis Can Exercise Program
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Centers for Disease Control and Prevention
Collaborators
University of Missouri-Columbia, St. Louis University

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to evaluate the health and arthritis-specific benefits of participation in the Arthritis Foundation People with Arthritis Can Exercise program and to collect information to improve community-based dissemination of this program.
Detailed Description
Only about 24% of people with arthritis report sufficient physical activity to provide general health benefits. Research has demonstrated that many people with arthritis can safely exercise to improve fitness and health. The People with Arthritis Can Exercise (PACE) program, developed by the Arthritis Foundation, is a land-based recreational physical activity and exercise program. PACE has been offered as a community-based program for over 10 years and small studies have reported benefits for people with arthritis. However, there has been no randomized controlled community trials that evaluate the effectiveness of PACE in the community. The goals of the Evaluation of PACE project are to: (1) appropriately evaluate the AF PACE exercise program, and (2) provide information to support effective content, recruitment and programming. Specific objectives for meeting these goals include: Identify the theoretical foundations and constructs for evaluating the program and select and use appropriate outcome measures; Plan and conduct a randomized controlled trial of 8 and 16 week PACE programs; Perform a qualitative evaluation using focus groups of PACE instructors and participants; Disseminate findings and make recommendations.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Osteoarthritis, Rheumatoid Arthritis
Keywords
arthritis, exercise, physical activity, physical function, pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
People with Arthritis Can Exercise
Primary Outcome Measure Information:
Title
Physical Activity Level - PASE instrument at baseline, 8 and 16 weeks.
Title
Pain Visual Analog Scale - at baseline, 8 and 16 weeks
Title
Physical Function using the Functional Fitness Battery at baseline, 8 and 16 weeks
Title
Self-reported function (HAQ) at baseline, 8 and 16 weeks
Secondary Outcome Measure Information:
Title
Health-related quality of life
Title
Disease status
Title
Self-efficacy for arthritis management
Title
Self-efficacy for exercise
Title
Social support
Title
Depressive symptoms
Title
Anxiety

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults age 18 and older Self-reported arthritis or chronic joint symptoms Community-dwelling Exclusion Criteria: Serious medical conditions which would contraindicate exercise No severe physical or mental condition
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer M Hootman, PhD
Organizational Affiliation
Centers for Disease Control and Prevention
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Marian Minor, PhD
Organizational Affiliation
University of Missouri-Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Louis University
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States

12. IPD Sharing Statement

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Program Evaluation of People With Arthritis Can Exercise

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