A Study of the Effectiveness of Different Types of Exercise for People With Knee Osteoarthritis (KBA Exercise)

This study has been completed.
Sponsor:
Information provided by:
The Arthritis Research Institute of America
ClinicalTrials.gov Identifier:
NCT00519922
First received: August 21, 2007
Last updated: July 21, 2008
Last verified: July 2008
  Purpose

This pilot study will test the testing and exercise training protocols for a larger study that is in the desing phase and may be modified based on the findings of this study. Two exercise groups will be compared; one is a stadard treatment group using leg strength exercises that are commonly employed in therapy clinics. The other group will do balance and agility type exercises, but no specific strength exercises. These "KBA" exercises are increasingly common in therapy clinics, but very little research has been conducted on their effectiveness in treating knee osteoarthritis symptoms. Participants in this study will complete three short paper and pencil tests at the beginning and end of the study (8 weeks of exercise) as well as a leg strength test, a leg endurance test, two short walking tests, and a stair climb/descend test. One of the paper and pencil tests will be taken every two weeks in an effort to see how quickly changes to symptoms might occur. The exercise programs will be conducted 3 afternoons per week (Mon-Wed-Fri) and will be lead by an ACSM certified instructor.


Condition Intervention
Knee Osteoarthritis
Other: Kinesthesia, Balance, and Agility (KBA) Exercise
Other: Standard LE Strength Training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Efficacy of Kinesthesia, Balance and Agility Exercise Training as Treatment of Knee Osteoarthritis: A Pilot Study

Resource links provided by NLM:


Further study details as provided by The Arthritis Research Institute of America:

Primary Outcome Measures:
  • WOMAC Osteoarthritis Scale; Function subscale change pre to post intervention - KBA vs. standard strength training [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • WOMAC subscale change in Pain and in Stiffness pre to post intervention [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Walking speed change in a timed Get Up & Go Test pre to post intervention [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Stair climbing and descending speed change pre to post intervention [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Gait quality measures with the GAITRite walking mat and EMG, pre to post intervention [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Spontaneous engagement in physical activity - change pre to post intervention as measured by the Human Activity Profile [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Efficacy for exercise change pre to post intervention as measured by the Self-Efficacy for Exercise scale. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: January 2008
Study Completion Date: July 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
KBA = Kinesthesia, Balance, Agility Exercise Training
Other: Kinesthesia, Balance, and Agility (KBA) Exercise

Participants will exercise three times per week 20 to 30 minutes per session. Agility/Active Range of Motion exercises provide warm-up, improve joint range-of-motion & agility, dynamic proprioception,functional strength & endurance.

Kinesthesia & Balance Training will challenge the subject's proprioceptive and neuromuscular control mechanisms to adapt and stabilize the knee joints during dynamic ADL activities (walking, climbing, etc); improve static and dynamic balance and sense of stability & confidence in ADL activities.

Soft pads will be used to progress some of the kinesthesia & balance challenge training. Thera-Band® balance pads at 3 levels of softness will be used. These balance pads allow both appropriate starting difficulty and progression of difficulty level (i.e., the softer the pad, the greater the difficulty). Subjects will demonstrate safe balance on a stable surface (i.e. one-footed standing on floor) prior to progressing to the first level of the soft pads.

Active Comparator: 2
Standard Lower Extremity Strength Training
Other: Standard LE Strength Training
Standard therapeutic exercises for knee OA which are widely used. Body weight and Thera-Band® color coded elastic bands will be used as appropriate to provide resistance. Exercises will be progressed according to the individual participant's improvement. All training for the ST condition will be conducted on stable surfaces (e.g. standing on floor, sitting in chair, lying on floor). Exercises may include 4-direction straight leg lifts, heel slides, quad sets, internal & external hip rotation, heel raises, toe raises, knee extension, knee flexion, partial squats/wall slides, etc.

Detailed Description:

Radiographic knee OA is present in an estimated 37% of Americans over the age of 60, representing more than 13 million people. Current medical, non-surgical knee OA treatments focus primarily on symptomatic relief and have met with limited, temporary success. Various therapeutic exercise prescriptions have been used to help ameliorate knee OA symptoms and improve function. Leg strength training is most commonly used. However, recent evidence suggests that shorter programs of kinesthesia, balance and agility (KBA) techniques may result in more rapid symptom relief and functional improvements in comparison to traditional therapeutic exercise. These early benefits could potentially lead to greater long term exercise adherence.

In a case study of an elderly female patient with dynamic knee instability related to OA, physical therapists reported success with a combination of KBA training and traditional therapeutic exercise. These findings need to be verified in a controlled clinical trial. This pilot study will help determine the proper testing and exercise training methods for a larger clinical trial, and will indicate if KBA training done without concurrent strength training is a viable intervention.

Research Hypothesis: Among men and women age 50 and over with Kellgren and Lawrence (1957) Grade 2 or higher symptomatic tibiofemoral OA in one or both knees, an 8-week, 3-day per week kinesthesia, balance & agility (KBA) exercise program - designed to increase dynamic neuromuscular knee stability - safely and effectively changes physical function more effectively than standard leg strength training

  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
  • Radiographic tibiofemoral OA grade 2 or higher, unilateral or bilateral
  • Demonstrated knee OA related dysfunction per WOMAC score
  • Not engaged in a regular exercise program for minimum of 6 months

Exclusion Criteria:

  • Inability to obtain physician release for exercise
  • High risk health status:

    e.g., uncontrolled medical conditions such as hypertension, diabetes, heart disease, pulmonary disease, high cholesterol, anginal type pain, dizziness or syncope, orthopnea or paroxysmal nocturnal dyspnea, ankle edema, heart palpitations or tachycardia, intermittent claudication, known heart murmur, unusual fatigue or shortness of breath with usual activities.

  • 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
  • Intra-articular joint injection within 4 weeks of the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00519922

Locations
United States, Florida
Morton Plant Mease Cheek-Powell Wellness Center
Clearwater, Florida, United States
Sponsors and Collaborators
The Arthritis Research Institute of America
Investigators
Principal Investigator: Matthew W Rogers, MS The Arthritis Research Institute of America
Study Director: Nauris Tamulevicius, PhD Morton Plant Mease Cheek-Powell Wellness Center
Study Chair: Frances V Wilder, PhD The Arthritis Research Institute of America
  More Information

No publications provided

Responsible Party: Matthew W Rogers, Director of Exercise Research, The Arthritis Research Institute of America
ClinicalTrials.gov Identifier: NCT00519922     History of Changes
Other Study ID Numbers: KneeOAExercise-1
Study First Received: August 21, 2007
Last Updated: July 21, 2008
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 18, 2014