Exercise and Physical Fitness for Persons With Knee Osteoarthritis

This study has been completed.
Sponsor:
Collaborator:
U.S. Department of Education
Information provided by:
University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT00265447
First received: December 13, 2005
Last updated: June 30, 2010
Last verified: June 2010
  Purpose

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.


Condition Intervention Phase
Knee Osteoarthritis
Behavioral: self-directed exercise
Behavioral: 3 months of aerobic conditioning
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Exercise and Physical Fitness for Persons With Knee Osteoarthritis: Does One Size Fit All

Resource links provided by NLM:


Further study details as provided by University of Missouri-Columbia:

Primary Outcome Measures:
  • WOMAC Pain scale [ Time Frame: baseline, 3 months, and 6 months ] [ Designated as safety issue: No ]
  • WOMAC physical function scale, muscle performance,flexibility, aerobic capacity, self-reported health status [ Time Frame: baseline, 3 months, 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • AIMS2 [ Time Frame: baseline, 3 months, 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: December 2005
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: strength training
3 months of strength training
Behavioral: self-directed exercise
Active Comparator: Aerobic conditioning Behavioral: self-directed exercise Behavioral: 3 months of aerobic conditioning
self-directed exercise
No Intervention: delayed exercise control group

Detailed 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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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,

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  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: NCT00265447

Locations
United States, Missouri
University of Missouri
Columbia, Missouri, United States, 65211
Sponsors and Collaborators
University of Missouri-Columbia
U.S. Department of Education
Investigators
Principal Investigator: Marian A Minor, PhD Department of Physical Therapy, School of Health Professions, University of Missouri-Columbia
  More Information

No publications provided

Responsible Party: Marion Minor, Principal Investigator, University of Missouri
ClinicalTrials.gov Identifier: NCT00265447     History of Changes
Other Study ID Numbers: H133B031120-Proj 2
Study First Received: December 13, 2005
Last Updated: June 30, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Missouri-Columbia:
knee osteoarthritis
exercise
aerobic exercise
strengthening exercise
exercise prescription
rehabilitation
physical disability
physical function
physical activity
physical fitness

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

ClinicalTrials.gov processed this record on September 14, 2014