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

Hypertension Clinical Trial

— AFEP+10 Keys  

Official title:

Arthritis Foundation Exercise Program & "10 Keys" to Healthy Aging

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01616433
• Other study ID #: IU48DP09-0014918-01
• Status: Completed
• Phase: Phase 2
• First received: June 7, 2012
• Last updated: December 17, 2014
• Start date: March 2012
• Est. completion date: October 2014

Study information

• Verified date: December 2014
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 462
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Arthritis
• Diabetes
• Hypertension
• Preventive Behaviors

Intervention

Behavioral:
• AFEP
Arthritis Foundation Exercise Program (10 weeks, twice a week, 60 minutes per session)
• "10 Keys" to Healthy Aging
"10 Keys" to Healthy Aging. 10 week program, twice a week, 75 minutes per session.

Locations

Country	Name	City	State
United States	Community sites	Allegheny County primarily	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	Arthritis Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preventive Behaviors	Measuring preventive behaviors emphasized by the "10 Keys" to Healthy Aging, such as cancer screenings, controlling blood pressure, immunizations, etc.	1 year	No
Primary	Joint Pain & Stiffness	Self-reported joint pain and stiffness, as measured by the WOMAC.	1 year	No
Primary	Cholesterol (LDL)	LDL cholesterol	1 year	No
Primary	Glucose	Fasting glucose	1 year	No