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Exercise Adherence Among Older Adults With Osteoarthritis

Primary Purpose

Osteoarthritis

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fit and Strong! Exercise Program
Sponsored by
National Institute on Aging (NIA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoarthritis focused on measuring Aging, exercise, health behavior

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 60 years of age or older
  • Presence of osteoarthritis in the lower extremities (including hip, knee, ankle, feet and lower back) with an American College of Rheumatology functional class rating of I, II, or III
  • No other contraindication from a personal physician for participation in fitness walking or low-impact aerobics and strength training
  • Lack of moderate to severe cognitive impairment shown as assessed by the Short Portable Mental Status Questionnaire

Exclusion Criteria:

  • Under 60 years of age
  • Lack of osteoarthritis in the lower extremities
  • Contraindication from a personal physician for participation in activities described above
  • Presence of moderate to severe cognitive impairment as assessed by the Short Portable Mental Status Questionnaire
  • Steroid injections in either knee or hip within previous six months
  • Knee or hip surgery within previous six months
  • Plans for total knee or hip replacement within the next year
  • Rheumatoid arthritis or other system inflammatory arthritis
  • Diabetes that is not under good control
  • Current participation in a structured aerobic exercise program
  • Participation in original trial of the Fit and Strong Program

Sites / Locations

  • Center for Research on Health and Aging

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

A

B

Arm Description

Treatment Arm A will develop tailored/negotiated contracts with the exercise instructor to maintain post intervention exercise adherence at home or in the community. Half of the participants in this "negotiated maintenance" arm will be randomly assigned to receive telephone calls to reinforce adherence and half will be assigned to a no telephone calls group.

Treatment Arm B will be mainstreamed into an ongoing facility-based exercise program for post intervention exercise adherence. Persons in this "mainstream follow up" arm will be randomly assigned such that half will receive regular telephone reinforcement follow up and half will not.

Outcomes

Primary Outcome Measures

Maintenance of exercise behavior measured by CHAMPS (Community Healthy Activities Model Program For Seniors)

Secondary Outcome Measures

Changes in lower extremity strength (timed sit-stand test)
Aerobic capacity (6 minute distance walk)
Pain, stiffness, physical function subscales measured by WOMAC (Western Ontario and McMaster osteoarthritis index)
Functional ability measured by GeriAIMS (Geriatric Arthritis Impact Measurement Scale)

Full Information

First Posted
January 10, 2007
Last Updated
December 10, 2009
Sponsor
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT00421681
Brief Title
Exercise Adherence Among Older Adults With Osteoarthritis
Official Title
Exercise Adherence Among Older Adults With Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Unknown status
Study Start Date
October 2003 (undefined)
Primary Completion Date
September 2008 (Anticipated)
Study Completion Date
September 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Aging (NIA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to assess the comparative effects of two different ways of enhancing long-term adherence to and benefits associated with participation in the evidence-based, Fit and Strong multi-component exercise intervention for older persons with lower extremity osteoarthritis.
Detailed Description
Osteoarthritis (OA) is the most common condition affecting older people today. It is the leading cause of disability among older people and its impact is projected to increase substantially with the aging of the U.S population from 43 million currently to 60 million by 2020. Promising 2- and 6-month outcomes have recently been reported from a randomized trial of a multi-component exercise intervention targeted at older adults with lower extremity OA. The Fit and Strong intervention, developed and tested as part of the Midwest Roybal Center for Health Maintenance, coupled strength training and aerobic walking with health education for sustained behavior change. Improvements have been found in confidence in ability to exercise, confidence in ability to continue exercising over time, lower extremity stiffness, lower extremity pain, and 6-minute distance walk. Importantly, the average adherence rate in the people who participated in the exercise intervention at six months was twice that reported by controls. The specific aims of this study are to use a multi-site randomized controlled clinical trial to replicate the Fit and Strong intervention and to test the comparative effectiveness of a negotiated/tailored follow-up maintenance strategy vs. a mainstreaming, facility-based maintenance strategy, both of which will be tested with and without telephone reinforcement as an enhancement. All enrolled participants will participate in the 8-week Fit and Strong exercise program designed specifically for older adults with lower-extremity OA. Prior to the conclusion of Fit and Strong participants will be randomly assigned to one of two follow-up maintenance groups. There is no more than minimal risk associated with this program.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Aging, exercise, health behavior

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Treatment Arm A will develop tailored/negotiated contracts with the exercise instructor to maintain post intervention exercise adherence at home or in the community. Half of the participants in this "negotiated maintenance" arm will be randomly assigned to receive telephone calls to reinforce adherence and half will be assigned to a no telephone calls group.
Arm Title
B
Arm Type
Experimental
Arm Description
Treatment Arm B will be mainstreamed into an ongoing facility-based exercise program for post intervention exercise adherence. Persons in this "mainstream follow up" arm will be randomly assigned such that half will receive regular telephone reinforcement follow up and half will not.
Intervention Type
Behavioral
Intervention Name(s)
Fit and Strong! Exercise Program
Intervention Description
Fit and Strong! is an 8-week (24 sessions) multi-component exercise and health education intervention, including flexibility, aerobic conditioning, strength training, and group discussion/problem solving for lifestyle change. Following participation in Fit and Strong!, all study participants are randomly assigned to one of 2 maintenance treatment follow-up groups.
Primary Outcome Measure Information:
Title
Maintenance of exercise behavior measured by CHAMPS (Community Healthy Activities Model Program For Seniors)
Time Frame
Baseline, 2 months, 6 months, 12 months, 18 months
Secondary Outcome Measure Information:
Title
Changes in lower extremity strength (timed sit-stand test)
Time Frame
Baseline, 2 months, 6 months, 12 months, 18 months
Title
Aerobic capacity (6 minute distance walk)
Time Frame
Baseline, 2 months, 6 months, 12 months, 18 months
Title
Pain, stiffness, physical function subscales measured by WOMAC (Western Ontario and McMaster osteoarthritis index)
Time Frame
Baseline, 2 months, 6 months, 12 months, 18 months
Title
Functional ability measured by GeriAIMS (Geriatric Arthritis Impact Measurement Scale)
Time Frame
Baseline, 2 months, 6 months, 12 months, 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 60 years of age or older Presence of osteoarthritis in the lower extremities (including hip, knee, ankle, feet and lower back) with an American College of Rheumatology functional class rating of I, II, or III No other contraindication from a personal physician for participation in fitness walking or low-impact aerobics and strength training Lack of moderate to severe cognitive impairment shown as assessed by the Short Portable Mental Status Questionnaire Exclusion Criteria: Under 60 years of age Lack of osteoarthritis in the lower extremities Contraindication from a personal physician for participation in activities described above Presence of moderate to severe cognitive impairment as assessed by the Short Portable Mental Status Questionnaire Steroid injections in either knee or hip within previous six months Knee or hip surgery within previous six months Plans for total knee or hip replacement within the next year Rheumatoid arthritis or other system inflammatory arthritis Diabetes that is not under good control Current participation in a structured aerobic exercise program Participation in original trial of the Fit and Strong Program
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Hughes, DSW
Organizational Affiliation
Center for Research on Health and Aging , University of Illinois, Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Research on Health and Aging
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60608
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15075418
Citation
Hughes SL, Seymour RB, Campbell R, Pollak N, Huber G, Sharma L. Impact of the fit and strong intervention on older adults with osteoarthritis. Gerontologist. 2004 Apr;44(2):217-28. doi: 10.1093/geront/44.2.217.
Results Reference
background
PubMed Identifier
17169935
Citation
Hughes SL, Seymour RB, Campbell RT, Huber G, Pollak N, Sharma L, Desai P. Long-term impact of Fit and Strong! on older adults with osteoarthritis. Gerontologist. 2006 Dec;46(6):801-14. doi: 10.1093/geront/46.6.801.
Results Reference
background
PubMed Identifier
19565560
Citation
Seymour RB, Hughes SL, Campbell RT, Huber GM, Desai P. Comparison of two methods of conducting the Fit and Strong! program. Arthritis Rheum. 2009 Jul 15;61(7):876-84. doi: 10.1002/art.24517.
Results Reference
derived

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Exercise Adherence Among Older Adults With Osteoarthritis

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