Knee OsteoarthritisKBA ExerciseNCT00519922
A Study of the Effectiveness of Different Types of Exercise for People With Knee Osteoarthritis
A study testing Kinesthesia, Balance, and Agility (KBA) Exercise and Standard LE Strength Training in people with Knee Osteoarthritis, run by The Arthritis Research Institute of America at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Kinesthesia, Balance, and Agility (KBA) Exercise and Standard LE Strength Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Jul 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Morton Plant Mease Cheek-Powell Wellness Center
Clearwater, Florida
About this study
Official title: Efficacy of Kinesthesia, Balance and Agility Exercise Training as Treatment of Knee Osteoarthritis: A Pilot Study
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.
Read the 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
- Conditions
- Knee Osteoarthritis
- Being tested
- Kinesthesia, Balance, and Agility (KBA) Exercise, Standard LE Strength Training
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesthesia, Balance, and Agility (KBA) ExerciseOther
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.
Standard LE Strength TrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | KBA = Kinesthesia, Balance, Agility Exercise Training Receives: Other: Kinesthesia, Balance, and Agility (KBA) Exercise |
| 2 | Active comparator | Standard Lower Extremity Strength Training Receives: Other: Standard LE Strength Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
WOMAC Osteoarthritis Scale; Function subscale change pre to post intervention - KBA vs. standard strength training
Measured: 8 weeks
Secondary outcomes (6)
WOMAC subscale change in Pain and in Stiffness pre to post intervention
Measured: 8 weeks
Walking speed change in a timed Get Up & Go Test pre to post intervention
Measured: 8 weeks
Stair climbing and descending speed change pre to post intervention
Measured: 8 weeks
Gait quality measures with the GAITRite walking mat and EMG, pre to post intervention
Measured: 8 weeks
Spontaneous engagement in physical activity - change pre to post intervention as measured by the Human Activity Profile
Measured: 8 weeks
Efficacy for exercise change pre to post intervention as measured by the Self-Efficacy for Exercise scale.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2007 (estimated)
- Study startJan 2008
- Primary completionJun 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Arthritis Research Institute of America
- Sponsor type
- University, hospital or other
- Investigators
- Matthew W Rogers, MS, Principal investigator, The Arthritis Research Institute of AmericaNauris Tamulevicius, PhD, Study director, Morton Plant Mease Cheek-Powell Wellness CenterFrances V Wilder, PhD, Study chair, The Arthritis Research Institute of America
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00519922
- Sponsor's protocol ID
- KneeOAExercise-1
- Acronym
- KBA Exercise
- Status last verified
- Jul 2008
- First submitted
- 21 Aug 2007
- Last updated
- 22 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Kinesthesia, Balance and Agility Exercise Training as Treatment of Knee Osteoarthritis: A Pilot Study
- ClinicalTrials.gov ID
- NCT00519922
- Acronym / sponsor ID
- KBA Exercise / KneeOAExercise-1
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The Arthritis Research Institute of AmericaUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 23 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Kinesthesia, Balance, and Agility (KBA) ExerciseKBA = Kinesthesia, Balance, Agility Exercise Training |
| 2 | Active comparator | Other: Standard LE Strength TrainingStandard Lower Extremity Strength Training |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kinesthesia, Balance, and Agility (KBA) ExerciseParticipants 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. | Other | 1 |
| Standard LE Strength TrainingStandard 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. | Other | 2 |
Primary outcome
WOMAC Osteoarthritis Scale; Function subscale change pre to post intervention - KBA vs. standard strength training
Time frame: 8 weeks
6 secondary outcomes
WOMAC subscale change in Pain and in Stiffness pre to post intervention
Time frame: 8 weeks
Walking speed change in a timed Get Up & Go Test pre to post intervention
Time frame: 8 weeks
Stair climbing and descending speed change pre to post intervention
Time frame: 8 weeks
Gait quality measures with the GAITRite walking mat and EMG, pre to post intervention
Time frame: 8 weeks
Spontaneous engagement in physical activity - change pre to post intervention as measured by the Human Activity Profile
Time frame: 8 weeks
Efficacy for exercise change pre to post intervention as measured by the Self-Efficacy for Exercise scale.
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew W Rogers, MS principal investigator
The Arthritis Research Institute of America
Nauris Tamulevicius, PhD study director
Morton Plant Mease Cheek-Powell Wellness Center
Frances V Wilder, PhD study chair
The Arthritis Research Institute of America
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesthesia, Balance, and Agility (KBA) Exercise and Standard LE Strength Training in people with Knee Osteoarthritis, run by The Arthritis Research Institute of America at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WOMAC Osteoarthritis Scale; Function subscale change pre to post intervention - KBA vs. standard strength training (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2008.