Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Matthew W. Rogers, MS, University of Zululand
ClinicalTrials.gov Identifier:
NCT00735098
First received: August 12, 2008
Last updated: February 4, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention
Osteoarthritis
 Other: KBA exercise
Other: strength training exercise
Other: KBA and strength training
Other: Control group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Effects of Home-Based Rehabilitation Treatments Among Persons With Symptomatic Knee Osteoarthritis.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Zululand:

Primary Outcome Measures:
  • (WOMAC) self assessment of physical function [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: January 2009
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
KBA exercise protocol
 Other: KBA exercise
KBA exercise protocol, 3 times per week for 8 weeks
Experimental: 2
strength training exercise protocol
 Other: strength training exercise
strength training exercise, 3 times per week for 8 weeks
Experimental: 3
KBA and strength training protocol
 Other: KBA and strength training
KBA and strength training exercise, 3 times per week for 8 weeks
Sham Comparator: 4 Other: Control group
8 week control group

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00735098

Locations
United States, Florida
University of Zululand
Saint Petersburg, Florida, United States, 33712
Sponsors and Collaborators
University of Zululand
Investigators
Principal Investigator: Matthew W Rogers, MS University of Zululand
  More Information

No publications provided

Responsible Party: Matthew W. Rogers, MS, Doctoral Student, University of Zululand, University of Zululand
ClinicalTrials.gov Identifier: NCT00735098     History of Changes
Other Study ID Numbers: KneeOAExercise-2
Study First Received: August 12, 2008
Last Updated: February 4, 2013
Health Authority: South Africa: University Ethics Committee

Keywords provided by University of Zululand:
Knee Osteoarthritis
arthritis

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 19, 2013