NCT00735098

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 12, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 14, 2008

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

February 6, 2013

Status Verified

February 1, 2013

Enrollment Period

3.9 years

First QC Date

August 12, 2008

Last Update Submit

February 4, 2013

Conditions

Keywords

Knee Osteoarthritisarthritis

Outcome Measures

Primary Outcomes (1)

  • (WOMAC) self assessment of physical function

    8 weeks

Study Arms (4)

1

EXPERIMENTAL

KBA exercise protocol

Other: KBA exercise

2

EXPERIMENTAL

strength training exercise protocol

Other: strength training exercise

3

EXPERIMENTAL

KBA and strength training protocol

Other: KBA and strength training

4

SHAM COMPARATOR
Other: Control group

Interventions

KBA exercise protocol, 3 times per week for 8 weeks

1

strength training exercise, 3 times per week for 8 weeks

2

KBA and strength training exercise, 3 times per week for 8 weeks

3

8 week control group

4

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

OsteoarthritisOsteoarthritis, KneeArthritis

Interventions

Resistance TrainingControl Groups

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Matthew W Rogers, MS

    University of Zululand

    PRINCIPAL INVESTIGATOR

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

Locations