- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00153309
Program Evaluation of People With Arthritis Can Exercise
Evaluation of the Health Benefits of the People With Arthritis Can Exercise Program
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
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Missouri
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St. Louis, Missouri, United States, 63104
- St. Louis University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Physical Activity Level - PASE instrument at baseline, 8 and 16 weeks.
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Pain Visual Analog Scale - at baseline, 8 and 16 weeks
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Physical Function using the Functional Fitness Battery at baseline, 8 and 16 weeks
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Self-reported function (HAQ) at baseline, 8 and 16 weeks
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Secondary Outcome Measures
Outcome Measure |
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Anxiety
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Health-related quality of life
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Disease status
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Self-efficacy for arthritis management
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Self-efficacy for exercise
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Social support
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Depressive symptoms
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Collaborators and Investigators
Investigators
- Study Director: Jennifer M Hootman, PhD, Centers for Disease Control and Prevention
- Principal Investigator: Marian Minor, PhD, University of Missouri-Columbia
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDC-NCCDPHP-0507
- CDC-NCCDPHP-MM-0507
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