Healia Clinical Trials Information Database

Exercise and Physical Fitness for Persons With Knee Osteoarthritis: Does One Size Fit All

The purpose of this project is to establish evidence to support specific, targeted exercise and rehabilitation recommendations for people over 50 with osteoarthritis of the knee.

Description

Physical disability and poor health often accompany knee osteoarthritis (OA), particularly as people age. This decline in function and quality of life is a complex phenomenon associated with numerous factors including pain, poor physical fitness, obesity, co-morbidity, low self-efficacy and lower extremity impairments. Furthermore, the effects of age, which have not been well studied in OA, must be considered. In addition to the functional losses associated with knee OA and aging, low levels of daily physical activity and exercise are common problems in this population for whom arthritis is a major reason for activity limitation. Evidence is accumulating that exercise can enhance health and quality of life and modify a number of the factors associated with disability. There is, however, little specific information to guide exercise prescription in the diverse population of people with knee OA. Although general benefit of exercise has been demonstrated, it is time to focus research questions on the specific types of exercise that produce specific effects; and for whom particular exercises are the most useful. Additionally, exercise has shown short term benefit, but how best to maintain gains and sustain exercise behaviors in self-directed and community settings is virtually untested. These questions are relevant to all people with knee OA, and become even more important as people grow older, become more sedentary and are at greater risk for frailty, poor health and disability.

This study is designed to: determine the efficacy of specific types of exercise by examining the effects of training on physiologic adaptations and physical performance; determine the effectiveness of a comprehensive exercise protocol performed in a supervised but non-medical setting, and describe the interaction of personal characteristics and disease severity with individual response to a particular exercise regimen.

Status: Completed (Phase 3). Started on December 1st, 2005.

Enrollment: 150 subjects

Study Type: Interventional

Study Design:

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

Conditions:

Interventions:

  • Behavioral: self-directed exercise
  • Behavioral: 3 months of aerobic conditioning

Eligibility

Inclusion Criteria:

community-dwelling, physician diagnosed osteoarthritis of the knee, willingness to exercise regularly, willingness to perform 3 testing sessions over a 6-month period, ability to exercise safely at a moderate level of intensity, knee osteoarthritis by clinical criteria,

WOMAC Scores as follows:

PAIN:”mild” pain on 2 items or “moderate” pain on 1 item; PHYSICAL FUNCTION: “mild” difficulty in 4 items or “moderate” difficulty in 2 items -

Exclusion Criteria:

age<50,inability to exercise and ambulate independently, physical limitation secondary to a condition that is not modifiable by exercise (e.g., active cancer), knee replacement (past or scheduled), total hip joint replacement less than 6 months ago, current participation in regular conditioning exercise, participation in another research study,

-

Gender

Both

Mininum Age

50 Years

Maximum Age

N/A

Healthy Volunteers

Accepts Healthy Volunteers


Resources

Source: University of Missouri-Columbia

Authority: United States: Institutional Review Board

Locations

  • University of Missouri
    Columbia
    Missouri
    65211
    United States

Officials

  • Marian A Minor, PhD (Principal Investigator, Department of Physical Therapy, School of Health Professions, University of Missouri-Columbia)

Sponsors

  • University of Missouri-Columbia (Lead Sponsor)

  • U.S. Department of Education (Collaborator)

References

None.

Links

None.


Date Verified
June 1st, 2010
First Received
June 30th, 2010
Last Changed
June 30th, 2010

Information obtained from ClinicalTrials.gov on June 09, 2011. Link to the current ClinicalTrials.gov record.


All data in the Healia Clinical Trials Information Database and content displayed by the Healia Clinical Trials Search Engine are licensed from the National Institutes of Health (National Library of Medicine), which collects and maintains the data.

The Healia Clinical Trials Search Engine searches the data set at clinicaltrials.gov, providing up-to-date information about current clinical trials. In the Healia Clinical Trials Database you can find information on new experimental drugs, medical devices, and other types of treatments for all types of diseases. Each clinical trial description includes information about the phase of the trial (phase I, phase II, or phase III), the trial’s methods, such as whether it is a randomized, placebo controlled, double blind study, and the status of the trial including whether or not the trial is currently enrolling new participants.


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