- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00526201
Help Arthritis With Exercise in West Virginia (HARE)
December 22, 2015 updated by: Jennifer Hootman
Arthritis Benefits of a Physical Activity Program in West Virginia: Evaluation of EnhanceFitness
The purpose of this project is to determine if an evidence-based, community-delivered physical activity program, EnhanceFitness, yields benefits for participants with arthritis.
The 3-year project will: 1) conduct a meta-analysis of community-based exercise programs for adults, 2) implement and evaluate the EnhanceFitness program in West Virginia using a randomized, controlled (wait list) design, and 3) disseminate the results to community and public health partners.
It is anticipated that participation in the EnhanceFitness program will result in reduced pain, improved physical function and physical activity levels for adults with arthritis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
323
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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West Virginia
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Morgantown, West Virginia, United States, 26506-9196
- West Virginia University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 18 and older
- Any type of self-reported, doctor-diagnosed arthritis
Exclusion Criteria:
- Any co-existing conditions where exercise is a contraindicated
- Impaired cognitive status
- Non-ambulatory
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Exercise
Subjects will be randomized to exercise (12 week EnhanceFitness class) or a wait-list control group.
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EnhanceFitness class for 12 weeks, 3 times per week for 1 hour sessions.
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Other: Control
Wait-list control group will receive intervention after 12-weeks.
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Participants randomized to the wait-list control group will continue their regular activities for 12 weeks and then be offered the exercise intervention (EnhanceFitness).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Pain Severity
Time Frame: 8 months
|
8 months
|
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Physical activity level
Time Frame: 8 months
|
8 months
|
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Physical Function
Time Frame: 8 months
|
8 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Health-related quality of life
Time Frame: 8 months
|
8 months
|
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Arthritis self-efficacy
Time Frame: 8 months
|
8 months
|
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Self-efficacy for exercise
Time Frame: 8 months
|
8 months
|
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Exercise perceptions
Time Frame: 8 months
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8 months
|
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Social support
Time Frame: 8 months
|
8 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Jennifer M Hootman, PhD, Centers for Disease Control and Prevention
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2009
Primary Completion (Actual)
January 1, 2011
Study Completion (Actual)
January 1, 2011
Study Registration Dates
First Submitted
September 6, 2007
First Submitted That Met QC Criteria
September 6, 2007
First Posted (Estimate)
September 10, 2007
Study Record Updates
Last Update Posted (Estimate)
December 24, 2015
Last Update Submitted That Met QC Criteria
December 22, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDC-NCCDPHP-AAMC-0944
- AAMC-0944
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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