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CompletedNCT01616433AFEP+10 KeysUpdated Dec 18, 2014

Arthritis Foundation Exercise Program & "10 Keys" to Healthy Aging--Prevention Research Center

A Phase 2 interventional study of AFEP and "10 Keys" to Healthy Aging in Arthritis, Diabetes and Hypertension, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-12-18.

Sponsored by University of Pittsburgh · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
462
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Arthritis
  • Diabetes
  • Hypertension
  • Preventive Behaviors

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Keywords

  • Arthritis
  • Preventive Behaviors
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 462 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 50+ years old
  • Attends at last one exercise class in a 10 week program

Exclusion criteria

Exclusion Criteria:

  • On oxygen
  • Hospitalized for cardiac event in past 6 months (at least 1 overnight)
  • Had major surgery in past 6 months
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
462 participants (actual)

Study arms

  • Active comparator
    Arthritis Foundation Exercise Program

    Behavioral: AFEP

  • 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

Interventions

  • BehavioralAFEP

    Arthritis Foundation Exercise Program (10 weeks, twice a week, 60 minutes per session)

    Also known as: Arthritis Foundation Exercise Program (10 weeks, twice a week, 60 minutes per session)

  • Behavioral"10 Keys" to Healthy Aging

    "10 Keys" to Healthy Aging. 10 week program, twice a week, 75 minutes per session.

06

What researchers measure

Primary outcomes

  1. Preventive Behaviors

    Measuring preventive behaviors emphasized by the "10 Keys" to Healthy Aging, such as cancer screenings, controlling blood pressure, immunizations, etc.

    Time frame: 1 year

  2. Joint Pain & Stiffness

    Self-reported joint pain and stiffness, as measured by the WOMAC.

    Time frame: 1 year

  3. Cholesterol (LDL)

    LDL cholesterol

    Time frame: 1 year

  4. Glucose

    Fasting glucose

    Time frame: 1 year

07

Study locations

1 site
  • Community sites
    Allegheny County primarily, Pennsylvania, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 18, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01616433
Lead sponsor
University of Pittsburgh
Collaborators
Arthritis Foundation
Responsible party
Sponsor
First posted
Jun 11, 2012
Start date
Mar 2012
Primary completion
Oct 2014
Completion
Oct 2014
Last update
Dec 18, 2014

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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