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Exercise and Physical Fitness for Persons With Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Strength training
Aerobic conditioning
Delayed exercise
Sponsored by
University of Missouri-Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring knee osteoarthritis, exercise, aerobic exercise, strengthening exercise, exercise prescription, rehabilitation, physical disability, physical function, physical activity, physical fitness

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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, -

Sites / Locations

  • University of Missouri

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Other

Arm Label

Strength training

Aerobic conditioning

Delayed exercise

Arm Description

3 months of strength training

3 months of aerobic conditioning

delayed exercise control group

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

AIMS2

Full Information

First Posted
December 13, 2005
Last Updated
September 26, 2016
Sponsor
University of Missouri-Columbia
Collaborators
U.S. Department of Education
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1. Study Identification

Unique Protocol Identification Number
NCT00265447
Brief Title
Exercise and Physical Fitness for Persons With Knee Osteoarthritis
Official Title
Exercise and Physical Fitness for Persons With Knee Osteoarthritis: Does One Size Fit All
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Missouri-Columbia
Collaborators
U.S. Department of Education

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
knee osteoarthritis, exercise, aerobic exercise, strengthening exercise, exercise prescription, rehabilitation, physical disability, physical function, physical activity, physical fitness

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Strength training
Arm Type
Active Comparator
Arm Description
3 months of strength training
Arm Title
Aerobic conditioning
Arm Type
Active Comparator
Arm Description
3 months of aerobic conditioning
Arm Title
Delayed exercise
Arm Type
Other
Arm Description
delayed exercise control group
Intervention Type
Behavioral
Intervention Name(s)
Strength training
Intervention Description
3 months of strength training
Intervention Type
Behavioral
Intervention Name(s)
Aerobic conditioning
Intervention Description
3 months of aerobic conditioning
Intervention Type
Behavioral
Intervention Name(s)
Delayed exercise
Intervention Description
delayed exercise control group
Primary Outcome Measure Information:
Title
WOMAC Pain scale
Time Frame
baseline, 3 months, and 6 months
Title
WOMAC physical function scale, muscle performance,flexibility, aerobic capacity, self-reported health status
Time Frame
baseline, 3 months, 6 months
Secondary Outcome Measure Information:
Title
AIMS2
Time Frame
baseline, 3 months, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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, -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marian A Minor, PhD
Organizational Affiliation
Department of Physical Therapy, School of Health Professions, University of Missouri-Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65211
Country
United States

12. IPD Sharing Statement

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Exercise and Physical Fitness for Persons With Knee Osteoarthritis

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