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

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00735098
• Other study ID #: KneeOAExercise-2
• Status: Completed
• Phase: N/A
• First received: August 12, 2008
• Last updated: February 4, 2013
• Start date: January 2009
• Est. completion date: December 2012

Study information

• Verified date: February 2013
• Source: University of Zululand
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: University Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• KBA exercise
KBA exercise protocol, 3 times per week for 8 weeks
• strength training exercise
strength training exercise, 3 times per week for 8 weeks
• KBA and strength training
KBA and strength training exercise, 3 times per week for 8 weeks
• Control group
8 week control group

Locations

Country	Name	City	State
United States	University of Zululand	Saint Petersburg	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Zululand

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	(WOMAC) self assessment of physical function		8 weeks	No