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

December 13, 2005
June 30, 2010
December 2005
September 2008   (final data collection date for primary outcome measure)
  • 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 ]
  • pain, physical function, muscle performance,flexibility, aerobic capacity, self-reported health status
  • Scores at baseline, 3 months and 6 months on:
Complete list of historical versions of study NCT00265447 on ClinicalTrials.gov Archive Site
AIMS2 [ Time Frame: baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
  • Scores at baseline, 3 months and 6 months on:
  • exercise behaviors and beliefs, knee joint proprioception, physical activity
Not Provided
Not Provided
 
Exercise and Physical Fitness for Persons With Knee Osteoarthritis
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Knee Osteoarthritis
  • Behavioral: self-directed exercise
  • Behavioral: 3 months of aerobic conditioning
    self-directed exercise
  • Active Comparator: strength training
    3 months of strength training
    Intervention: Behavioral: self-directed exercise
  • Active Comparator: Aerobic conditioning
    Interventions:
    • Behavioral: self-directed exercise
    • Behavioral: 3 months of aerobic conditioning
  • No Intervention: delayed exercise control group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
September 2008
September 2008   (final data collection date for primary outcome measure)

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,

-

Both
50 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00265447
H133B031120-Proj 2
Not Provided
Marion Minor, Principal Investigator, University of Missouri
University of Missouri-Columbia
U.S. Department of Education
Principal Investigator: Marian A Minor, PhD Department of Physical Therapy, School of Health Professions, University of Missouri-Columbia
University of Missouri-Columbia
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP