Exercise Adherence Among Older Adults With Osteoarthritis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by National Institute on Aging (NIA).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00421681
First received: January 10, 2007
Last updated: December 10, 2009
Last verified: January 2008
  Purpose

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.


Condition Intervention
Osteoarthritis
Behavioral: Fit and Strong! Exercise Program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Exercise Adherence Among Older Adults With Osteoarthritis

Resource links provided by NLM:


Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in lower extremity strength (timed sit-stand test) [ Time Frame: Baseline, 2 months, 6 months, 12 months, 18 months ] [ Designated as safety issue: No ]
  • Aerobic capacity (6 minute distance walk) [ Time Frame: Baseline, 2 months, 6 months, 12 months, 18 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Functional ability measured by GeriAIMS (Geriatric Arthritis Impact Measurement Scale) [ Time Frame: Baseline, 2 months, 6 months, 12 months, 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: October 2003
Estimated Study Completion Date: September 2008
Estimated Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
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.
Behavioral: Fit and Strong! Exercise Program
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.
Experimental: B
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.
Behavioral: Fit and Strong! Exercise Program
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.

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00421681

Locations
United States, Illinois
Center for Research on Health and Aging
Chicago, Illinois, United States, 60608
Sponsors and Collaborators
Investigators
Principal Investigator: Susan Hughes, DSW Center for Research on Health and Aging , University of Illinois, Chicago
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Susan L. Hughes, DSW, Professor and Co-Director, Center for Research on Health and Aging, Institute for Health Research and Policy, University of Illinois Chicago
ClinicalTrials.gov Identifier: NCT00421681     History of Changes
Other Study ID Numbers: AG0075, 5 R01 AG023424
Study First Received: January 10, 2007
Last Updated: December 10, 2009
Health Authority: United States: Federal Government

Keywords provided by National Institute on Aging (NIA):
Aging
exercise
health behavior

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 22, 2014