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

Primary Purpose

Arthritis, Diabetes, Hypertension

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AFEP
"10 Keys" to Healthy Aging
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Arthritis focused on measuring Arthritis, Preventive Behaviors

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Community sites

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arthritis Foundation Exercise Program

AFEP + 10 Keys to Healthy Aging

Arm Description

Arthritis Foundation Exercise Program integrated with the "10 Keys" to Healthy Aging

Outcomes

Primary Outcome Measures

Preventive Behaviors
Measuring preventive behaviors emphasized by the "10 Keys" to Healthy Aging, such as cancer screenings, controlling blood pressure, immunizations, etc.
Joint Pain & Stiffness
Self-reported joint pain and stiffness, as measured by the WOMAC.
Cholesterol (LDL)
LDL cholesterol
Glucose
Fasting glucose

Secondary Outcome Measures

Full Information

First Posted
June 7, 2012
Last Updated
December 17, 2014
Sponsor
University of Pittsburgh
Collaborators
Arthritis Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01616433
Brief Title
Arthritis Foundation Exercise Program & "10 Keys" to Healthy Aging--Prevention Research Center
Acronym
AFEP+10 Keys
Official Title
Arthritis Foundation Exercise Program & "10 Keys" to Healthy Aging
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pittsburgh
Collaborators
Arthritis Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Diabetes, Hypertension, Preventive Behaviors
Keywords
Arthritis, Preventive Behaviors

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
462 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arthritis Foundation Exercise Program
Arm Type
Active Comparator
Arm Title
AFEP + 10 Keys to Healthy Aging
Arm Type
Experimental
Arm Description
Arthritis Foundation Exercise Program integrated with the "10 Keys" to Healthy Aging
Intervention Type
Behavioral
Intervention Name(s)
AFEP
Other Intervention Name(s)
Arthritis Foundation Exercise Program (10 weeks, twice a week, 60 minutes per session)
Intervention Description
Arthritis Foundation Exercise Program (10 weeks, twice a week, 60 minutes per session)
Intervention Type
Behavioral
Intervention Name(s)
"10 Keys" to Healthy Aging
Intervention Description
"10 Keys" to Healthy Aging. 10 week program, twice a week, 75 minutes per session.
Primary Outcome Measure Information:
Title
Preventive Behaviors
Description
Measuring preventive behaviors emphasized by the "10 Keys" to Healthy Aging, such as cancer screenings, controlling blood pressure, immunizations, etc.
Time Frame
1 year
Title
Joint Pain & Stiffness
Description
Self-reported joint pain and stiffness, as measured by the WOMAC.
Time Frame
1 year
Title
Cholesterol (LDL)
Description
LDL cholesterol
Time Frame
1 year
Title
Glucose
Description
Fasting glucose
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Community sites
City
Allegheny County primarily
State/Province
Pennsylvania
Country
United States

12. IPD Sharing Statement

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

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