Program Evaluation of People With Arthritis Can Exercise

This study has been completed.
Sponsor:
Collaborators:
University of Missouri-Columbia
St. Louis University
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00153309
First received: September 7, 2005
Last updated: November 16, 2005
Last verified: September 2005
  Purpose

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.


Condition Intervention Phase
Arthritis
Osteoarthritis
Rheumatoid Arthritis
Behavioral: People with Arthritis Can Exercise
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Health Benefits of the People With Arthritis Can Exercise Program

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

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

Estimated Enrollment: 320
Study Start Date: June 2003
Estimated Study Completion Date: June 2005
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:

  1. Identify the theoretical foundations and constructs for evaluating the program and select and use appropriate outcome measures;
  2. Plan and conduct a randomized controlled trial of 8 and 16 week PACE programs;
  3. Perform a qualitative evaluation using focus groups of PACE instructors and participants;
  4. Disseminate findings and make recommendations.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00153309

Locations
United States, Missouri
St. Louis University
St. Louis, Missouri, United States, 63104
Sponsors and Collaborators
University of Missouri-Columbia
St. Louis University
Investigators
Study Director: Jennifer M Hootman, PhD Centers for Disease Control and Prevention
Principal Investigator: Marian Minor, PhD University of Missouri-Columbia
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00153309     History of Changes
Other Study ID Numbers: CDC-NCCDPHP-0507, CDC-NCCDPHP-MM-0507
Study First Received: September 7, 2005
Last Updated: November 16, 2005
Health Authority: United States: Federal Government

Keywords provided by Centers for Disease Control and Prevention:
arthritis
exercise
physical activity
physical function
pain

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Osteoarthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 29, 2014