Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Arthritis Foundation Exercise Program & "10 Keys" to Healthy Aging--Prevention Research Center (AFEP+10 Keys)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by University of Pittsburgh.
Recruitment status was  Recruiting
Arthritis Foundation
Information provided by (Responsible Party):
University of Pittsburgh Identifier:
First received: June 7, 2012
Last updated: June 8, 2012
Last verified: May 2012

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.

Condition Intervention Phase
Preventive Behaviors
Behavioral: AFEP
Behavioral: "10 Keys" to Healthy Aging
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Arthritis Foundation Exercise Program & "10 Keys" to Healthy Aging

Resource links provided by NLM:

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Preventive Behaviors [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Measuring preventive behaviors emphasized by the "10 Keys" to Healthy Aging, such as cancer screenings, controlling blood pressure, immunizations, etc.

  • Joint Pain & Stiffness [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Self-reported joint pain and stiffness, as measured by the WOMAC.

  • Cholesterol (LDL) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    LDL cholesterol

  • Glucose [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Fasting glucose

Estimated Enrollment: 400
Study Start Date: March 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arthritis Foundation Exercise Program Behavioral: AFEP
Arthritis Foundation Exercise Program (10 weeks, twice a week, 60 minutes per session)
Other Name: Arthritis Foundation Exercise Program (10 weeks, twice a week, 60 minutes per session)
Experimental: AFEP + 10 Keys to Healthy Aging
Arthritis Foundation Exercise Program integrated with the "10 Keys" to Healthy Aging
Behavioral: "10 Keys" to Healthy Aging
"10 Keys" to Healthy Aging. 10 week program, twice a week, 75 minutes per session.
Other Name: "10 Keys" to Healthy Aging


Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
  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 identifier: NCT01616433

Contact: Joni Vanderbilt, MPH 412-383-2384
Contact: Janice Zgibor, PhD 412-383-1942

United States, Pennsylvania
Community sites Recruiting
Allegheny County primarily, Pennsylvania, United States
Contact: Joni Vanderbilt, MPH    4123832384   
Contact: Andrea Arrington, MPH    412-383-1303   
Sub-Investigator: Janice Zgibor, PhD         
Sponsors and Collaborators
University of Pittsburgh
Arthritis Foundation
  More Information

No publications provided

Responsible Party: University of Pittsburgh Identifier: NCT01616433     History of Changes
Other Study ID Numbers: IU48DP09-0014918-01
Study First Received: June 7, 2012
Last Updated: June 8, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Preventive Behaviors

Additional relevant MeSH terms:
Cardiovascular Diseases
Joint Diseases
Musculoskeletal Diseases
Vascular Diseases processed this record on November 20, 2014