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

NCT00519922 | Completed

• 1 other identifier: KneeOAExercise-1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• WOMAC Osteoarthritis Scale; Function subscale change pre to post intervention - KBA vs. standard strength training

  8 weeks

Secondary Outcomes (6)

• WOMAC subscale change in Pain and in Stiffness pre to post intervention

  8 weeks

• Walking speed change in a timed Get Up & Go Test pre to post intervention

  8 weeks

• Stair climbing and descending speed change pre to post intervention

  8 weeks

• Gait quality measures with the GAITRite walking mat and EMG, pre to post intervention

  8 weeks

• Spontaneous engagement in physical activity - change pre to post intervention as measured by the Human Activity Profile

  8 weeks

Study Arms (2)

1

EXPERIMENTAL

KBA = Kinesthesia, Balance, Agility Exercise Training

Other: Kinesthesia, Balance, and Agility (KBA) Exercise

2

ACTIVE COMPARATOR

Standard Lower Extremity Strength Training

Other: Standard LE Strength Training

Interventions

Kinesthesia, Balance, and Agility (KBA) Exercise OTHER

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.

1

Standard LE Strength Training OTHER

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.

2

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Arthritis Research Institute of America: lead

Study Sites (1)

Morton Plant Mease Cheek-Powell Wellness Center

Clearwater, Florida, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Kinesthesis; Exercise

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Proprioception; Sensation; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena

Study Officials

• Matthew W Rogers, MS

  The Arthritis Research Institute of America

  PRINCIPAL INVESTIGATOR

• Nauris Tamulevicius, PhD

  Morton Plant Mease Cheek-Powell Wellness Center

  STUDY DIRECTOR

• Frances V Wilder, PhD

  The Arthritis Research Institute of America

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 21, 2007
• First Posted: August 23, 2007
• Study Start: January 1, 2008
• Primary Completion: June 1, 2008
• Study Completion: July 1, 2008
• Last Updated: July 22, 2008

Record last verified: 2008-07

Locations

US (1)