NCT01616433

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
462

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 11, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

December 18, 2014

Status Verified

December 1, 2014

Enrollment Period

2.6 years

First QC Date

June 7, 2012

Last Update Submit

December 17, 2014

Conditions

Keywords

ArthritisPreventive Behaviors

Outcome Measures

Primary Outcomes (4)

  • Preventive Behaviors

    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

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

    1 year

  • Cholesterol (LDL)

    LDL cholesterol

    1 year

  • Glucose

    Fasting glucose

    1 year

Study Arms (2)

Arthritis Foundation Exercise Program

ACTIVE COMPARATOR
Behavioral: AFEP

AFEP + 10 Keys to Healthy Aging

EXPERIMENTAL

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

Behavioral: "10 Keys" to Healthy Aging

Interventions

AFEPBEHAVIORAL

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)
Arthritis Foundation Exercise Program

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

AFEP + 10 Keys to Healthy Aging

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Community sites

Allegheny County Primarily, Pennsylvania, United States

Location

MeSH Terms

Conditions

ArthritisDiabetes MellitusHypertension

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2012

First Posted

June 11, 2012

Study Start

March 1, 2012

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

December 18, 2014

Record last verified: 2014-12

Locations