- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01616433
Arthritis Foundation Exercise Program & "10 Keys" to Healthy Aging--Prevention Research Center (AFEP+10 Keys)
December 17, 2014 updated by: University of Pittsburgh
Arthritis Foundation Exercise Program & "10 Keys" to Healthy Aging
Older adults are at high risk for loss of independence because of age-related chronic health conditions.
Of these chronic conditions, arthritis accounts for the largest proportion of the disability in the community.
The investigators propose to target older adults who have self-reported arthritis or joint pain for dissemination of a disability prevention program.
The program will be a collaborative effort of the Arthritis Foundation, the investigators Prevention Research Center staff and other key partners in the community.
The project will develop information needed to provide guidance for implementation of the investigators intervention by other agencies and organizations.
As a major thrust of the investigators CDC Prevention Research Center, the investigators have developed a comprehensive program focused on preventing disease and disability in older adults: the "10 Keys to Healthy Aging".
Each of the 10 Keys disseminates proven approaches and current recommendations for prevention in older adults, focusing on age 65+ but also addressing age 50-65 years.
The overall objective is to determine if an integrated evidence based exercise intervention (AFEP) combined with health education on preventive practices for older adults ("10 Keys") is more effective for improving mobility and risk factors for mobility disability and use of preventive services compared to exercise alone (AFEP).
The investigators will also propose to evaluate the impact of geographic location on outcomes and overall sustainability of the program.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
462
Phase
- Phase 2
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
-
-
Pennsylvania
-
Allegheny County primarily, Pennsylvania, United States
- Community sites
-
-
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
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 50+ years old
- Attends at last one exercise class in a 10 week program
Exclusion Criteria:
- On oxygen
- Hospitalized for cardiac event in past 6 months (at least 1 overnight)
- Had major surgery in past 6 months
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Arthritis Foundation Exercise Program
|
Arthritis Foundation Exercise Program (10 weeks, twice a week, 60 minutes per session)
Other Names:
|
Experimental: AFEP + 10 Keys to Healthy Aging
Arthritis Foundation Exercise Program integrated with the "10 Keys" to Healthy Aging
|
"10 Keys" to Healthy Aging. 10 week program, twice a week, 75 minutes per session.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Preventive Behaviors
Time Frame: 1 year
|
Measuring preventive behaviors emphasized by the "10 Keys" to Healthy Aging, such as cancer screenings, controlling blood pressure, immunizations, etc.
|
1 year
|
Joint Pain & Stiffness
Time Frame: 1 year
|
Self-reported joint pain and stiffness, as measured by the WOMAC.
|
1 year
|
Cholesterol (LDL)
Time Frame: 1 year
|
LDL cholesterol
|
1 year
|
Glucose
Time Frame: 1 year
|
Fasting glucose
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
March 1, 2012
Primary Completion (Actual)
October 1, 2014
Study Completion (Actual)
October 1, 2014
Study Registration Dates
First Submitted
June 7, 2012
First Submitted That Met QC Criteria
June 8, 2012
First Posted (Estimate)
June 11, 2012
Study Record Updates
Last Update Posted (Estimate)
December 18, 2014
Last Update Submitted That Met QC Criteria
December 17, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IU48DP09-0014918-01
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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