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Improving Walking in Older Adults With Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gait Training
Sponsored by
University of Iowa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Osteoarthritis, Gait training, Knee pain, Rehabilitation, Physical Therapy

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Symptomatic knee osteoarthritis (knee osteoarthritis diagnosed by x-ray and frequent knee symptoms)
  • Age 60 or older

Exclusion Criteria:

  • acute or terminal illness
  • unstable cardiovascular condition or other medical conditions that may impair ability to participate such as pulmonary disease requiring the use of supplemental oxygen, neurological disease that affects gait, or lower limb musculoskeletal surgery in the past 6 months.
  • Bilateral knee replacement

Sites / Locations

  • University of Iowa

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Gait training

Outcomes

Primary Outcome Measures

Changes in functional limitation assessed by the A) Summary Performance Score which includes balance tests, timed 4-meter walk, and timed chair stand test B) Timed stair climb C) Late Life Function and Disability Instrument (LLFDI) Questionnaire
Changes in the disability measure, a timed 400 meter walk
Changes in impairments assessed using the Knee and Osteoarthritis Outcome Score (KOOS) questionnaire

Secondary Outcome Measures

Full Information

First Posted
December 20, 2007
Last Updated
March 7, 2017
Sponsor
University of Iowa
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT00583245
Brief Title
Improving Walking in Older Adults With Knee Osteoarthritis
Official Title
Optimizing Mobility in Older Adults With Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Iowa
Collaborators
National Institute on Aging (NIA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Knee osteoarthritis (OA) accounts for a significant proportion of mobility limitations and is one of the most disabling problems facing the growing population of older adults. The long-term objective of this research is to reduce disablement of older adults with symptomatic knee OA. The principle of specificity of training indicates that exercises that closely approximate the goal functional activity are most effective in improving physical performance during that activity. Based on this principle, the specific aim of this pilot study is to design a patient-specific gait training intervention using analysis of compensatory joint moments and energy expenditure. Successful completion will inform rehabilitation for maintaining or improving mobility as well as explore the mechanism of effect.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Osteoarthritis, Gait training, Knee pain, Rehabilitation, Physical Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Gait training
Intervention Type
Other
Intervention Name(s)
Gait Training
Intervention Description
Gait training with physical therapist 2/week for 3 months
Primary Outcome Measure Information:
Title
Changes in functional limitation assessed by the A) Summary Performance Score which includes balance tests, timed 4-meter walk, and timed chair stand test B) Timed stair climb C) Late Life Function and Disability Instrument (LLFDI) Questionnaire
Time Frame
12 weeks
Title
Changes in the disability measure, a timed 400 meter walk
Time Frame
12 Weeks
Title
Changes in impairments assessed using the Knee and Osteoarthritis Outcome Score (KOOS) questionnaire
Time Frame
12 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Symptomatic knee osteoarthritis (knee osteoarthritis diagnosed by x-ray and frequent knee symptoms) Age 60 or older Exclusion Criteria: acute or terminal illness unstable cardiovascular condition or other medical conditions that may impair ability to participate such as pulmonary disease requiring the use of supplemental oxygen, neurological disease that affects gait, or lower limb musculoskeletal surgery in the past 6 months. Bilateral knee replacement
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil Segal, MD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States

12. IPD Sharing Statement

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Improving Walking in Older Adults With Knee Osteoarthritis

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