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The Effects of Home-Based Rehabilitation Treatments Among Persons With Symptomatic Knee Osteoarthritis

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
KBA exercise
strength training exercise
KBA and strength training
Control group
Sponsored by
University of Zululand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Knee Osteoarthritis, arthritis

Eligibility Criteria

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

Inclusion Criteria:

  • Aged 50 years or over of either gender
  • Self-reported knee pain
  • Physician diagnosed tibiofemoral OA, unilateral or bilateral, per ACR guidelines
  • Demonstrated minimal knee OA related dysfunction per WOMAC score
  • Not engaged in a regular leg exercise program for minimum of 6 months

Exclusion Criteria:

  • High risk health status per (e.g.) ACSM guidelines
  • Inability to obtain physician release for exercise
  • Unresolved balance disorder
  • Unresolved neurological disorder
  • History of knee surgery or major knee trauma injury
  • Hip or ankle instability, excessive weakness, surgery or major trauma injury
  • Hip or knee replacement
  • Intra-articular joint injection within 4 weeks of the study

Sites / Locations

  • University of Zululand

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Sham Comparator

Arm Label

1

2

3

4

Arm Description

KBA exercise protocol

strength training exercise protocol

KBA and strength training protocol

Outcomes

Primary Outcome Measures

(WOMAC) self assessment of physical function

Secondary Outcome Measures

Full Information

First Posted
August 12, 2008
Last Updated
February 4, 2013
Sponsor
University of Zululand
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1. Study Identification

Unique Protocol Identification Number
NCT00735098
Brief Title
The Effects of Home-Based Rehabilitation Treatments Among Persons With Symptomatic Knee Osteoarthritis
Official Title
The Effects of Home-Based Rehabilitation Treatments Among Persons With Symptomatic Knee Osteoarthritis.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Zululand

4. Oversight

5. Study Description

Brief Summary
Knee Osteoarthritis (OA) is one of the most frequent causes of physical disability and pain among adults. Recent evidence suggests that shorter exercise programs that incorporate kinesthesia, balance and agility (KBA) techniques may result in more rapid symptom relief and functional improvements in comparison to traditional therapeutic exercise. KBA techniques are designed to improve dynamic joint stability by using a series of activities which challenge balance and coordination. To determine the independent effects of KBA training on functional abilities, it is necessary to test it as a training program unto itself. The proposed clinical trial is designed to do this by using three training groups: KBA only; lower extremity strength training only; and a combination of the two. The total exercise time and intensity of each condition will be approximately equal. A non-exercise group will control for any effects related to the testing procedures and the passage of time. Community volunteer men and women age 50 and over with physician diagnosed symptomatic knee OA will participate.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Knee Osteoarthritis, arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
KBA exercise protocol
Arm Title
2
Arm Type
Experimental
Arm Description
strength training exercise protocol
Arm Title
3
Arm Type
Experimental
Arm Description
KBA and strength training protocol
Arm Title
4
Arm Type
Sham Comparator
Intervention Type
Other
Intervention Name(s)
KBA exercise
Intervention Description
KBA exercise protocol, 3 times per week for 8 weeks
Intervention Type
Other
Intervention Name(s)
strength training exercise
Intervention Description
strength training exercise, 3 times per week for 8 weeks
Intervention Type
Other
Intervention Name(s)
KBA and strength training
Intervention Description
KBA and strength training exercise, 3 times per week for 8 weeks
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
8 week control group
Primary Outcome Measure Information:
Title
(WOMAC) self assessment of physical function
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 50 years or over of either gender Self-reported knee pain Physician diagnosed tibiofemoral OA, unilateral or bilateral, per ACR guidelines Demonstrated minimal knee OA related dysfunction per WOMAC score Not engaged in a regular leg exercise program for minimum of 6 months Exclusion Criteria: High risk health status per (e.g.) ACSM guidelines Inability to obtain physician release for exercise Unresolved balance disorder Unresolved neurological disorder History of knee surgery or major knee trauma injury Hip or ankle instability, excessive weakness, surgery or major trauma injury Hip or knee replacement Intra-articular joint injection within 4 weeks of the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew W Rogers, MS
Organizational Affiliation
University of Zululand
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Zululand
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33712
Country
United States

12. IPD Sharing Statement

Learn more about this trial

The Effects of Home-Based Rehabilitation Treatments Among Persons With Symptomatic Knee Osteoarthritis

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