The Effects of Home-Based Rehabilitation Treatments Among Persons With Symptomatic Knee Osteoarthritis
1 other identifier
interventional
44
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 12, 2008
CompletedFirst Posted
Study publicly available on registry
August 14, 2008
CompletedStudy Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedFebruary 6, 2013
February 1, 2013
3.9 years
August 12, 2008
February 4, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
(WOMAC) self assessment of physical function
8 weeks
Study Arms (4)
1
EXPERIMENTALKBA exercise protocol
2
EXPERIMENTALstrength training exercise protocol
3
EXPERIMENTALKBA and strength training protocol
4
SHAM COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Zululand
St. Petersburg, Florida, 33712, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Matthew W Rogers, MS
University of Zululand
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctoral Student, University of Zululand
Study Record Dates
First Submitted
August 12, 2008
First Posted
August 14, 2008
Study Start
January 1, 2009
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
February 6, 2013
Record last verified: 2013-02