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CompletedNCT00265447Updated Sep 28, 2016

Exercise and Physical Fitness for Persons With Knee Osteoarthritis

A Phase 3 interventional study of Strength training and Aerobic conditioning in Knee Osteoarthritis, sponsored by University of Missouri-Columbia. Completed at 1 site in United States. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-09-28.

Sponsored by University of Missouri-Columbia · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
55
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Knee Osteoarthritis

Keywords

  • knee osteoarthritis
  • exercise
  • aerobic exercise
  • strengthening exercise
  • exercise prescription
  • rehabilitation
  • physical disability
  • physical function
  • physical activity
  • physical fitness
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 55 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

University of Missouri-Columbia is the lead sponsor of 357 studies on the registry; 70 are open to participants now.

Of its 42 completed or terminated interventional studies of FDA-regulated products, 28 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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,

-

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
55 participants (actual)

Study arms

  • Active comparator
    Strength training

    3 months of strength training

    Behavioral: Strength training

  • Active comparator
    Aerobic conditioning

    3 months of aerobic conditioning

    Behavioral: Aerobic conditioning

  • Other
    Delayed exercise

    delayed exercise control group

    Behavioral: Delayed exercise

Interventions

  • BehavioralStrength training

    3 months of strength training

  • BehavioralAerobic conditioning

    3 months of aerobic conditioning

  • BehavioralDelayed exercise

    delayed exercise control group

06

What researchers measure

Primary outcomes

  1. WOMAC Pain scale

    Time frame: baseline, 3 months, and 6 months

  2. WOMAC physical function scale, muscle performance,flexibility, aerobic capacity, self-reported health status

    Time frame: baseline, 3 months, 6 months

Secondary outcomes

  1. AIMS2

    Time frame: baseline, 3 months, 6 months

07

Study locations

1 site
  • University of Missouri
    Columbia, Missouri 65211, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 28, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00265447
Lead sponsor
University of Missouri-Columbia
Collaborators
U.S. Department of Education
Responsible party
Sponsor
First posted
Dec 14, 2005
Start date
Dec 2005
Primary completion
Jul 2011
Completion
Jul 2011
Last update
Sep 28, 2016

Study contacts

Marian A Minor, PhD
principal investigator · Department of Physical Therapy, School of Health Professions, University of Missouri-Columbia
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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