Back to resultsRandomized Controlled Trial of Dynamic Balance Training in People With Knee Osteoarthritis
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Targeted dynamic balance training
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring balance, knee, osteoarthritis, physical function
Eligibility Criteria
Inclusion Criteria:
- age 50 - 80 years (to meet the American College of Rheumatology clinical definition of OA)
- radiographically confirmed knee OA in the medial compartment of the tibiofemoral joint
- predominance of pain/tenderness over the medial (inside) region of the knee
Exclusion Criteria:
- articular cartilage degradation in the lateral tibiofemoral compartment greater than the medial
- inflammatory arthritic condition
- history of knee or hip replacement surgery
- recent use of corticosteroids (oral or via injection, within last 6 months)
- pain originating predominantly from the patellofemoral joint
- inability to ambulate without a gait aid
- non-English speaking
- recent (within 6 months) arthroscopic knee surgery
- significant hip or back pain (limits the ability to perform the testing)
- Neurological, musculoskeletal or other condition that affects movement ability or balance (i.e. stroke, diabetes, Parkinson's, heart attack, multiple sclerosis, fibromyalgia)
Sites / Locations
- Motion Analysis and Biofeedback Laboratory, The University of British Columbia
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Wait list
Treatment (balance training)
Arm Description
Wait list control group. Participants will be placed on the wait list and asked to maintain their current routine and level of activity during the 10 week period. Control group participants will receive the dynamic balance training program in a single training session after the followup (second testing session at 10 weeks).
Targeted dynamic balance training. Dynamic balance training will consist of progressive exercise training over three phases, with exercises emphasising dynamic balance control, muscle strength and proprioception. Exercises will be performed four times per week for ten weeks. Exercises will be taught and supervised by a trained kinesiologist. Difficulty of exercises will be increased progressively over time by increasing resistance, time of timed exercises, and distance of walking exercises. Exercises will be progressed to different exercises in each new phase (total 3 phases). Participants will complete six treatment sessions at the university (during weeks 1, 2, 3, 5, 7, and 9) that will be included in the total number of sessions per week. All other sessions will be performed at home.
Outcomes
Primary Outcome Measures
Change in dynamic balance and mobility from baseline
The Community Balance and Mobility Scale (CB&M) will be used to assess dynamic balance and mobility. The CB&M is a scale designed to assess dynamic balance and mobility and is administered by a trained assessor. The scale consists of 13 items including bending, walking, turning, and stair descent, with a maximum possible score of 96 and minimum score of 0. The scale has been validated and deemed reliable for use in the knee osteoarthritis population.
Change in self-reported physical function from baseline
The Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) will be used to assess self-reported physical function. The WOMAC physical function subscale consists of 17 questions assessing physical function capabilities during activities of daily living.
Secondary Outcome Measures
Change in knee pain from baseline
Average pain over the previous week will be assessed using an 11-point numerical rating scale (0 = no pain; 10 = worst pain possible).
Change in fear of pain from baseline
The Brief Fear of Movement Scale will be used to assess fear of pain. This scale is based on the widely used Tampa Scale of Kinesiophobia and contains 6 questions that evaluate fear of pain, movement and re-injury. The scale has been validated in individuals with OA.
Change in self-reported physical activity level from baseline
The Physical Activity Scale for the Elderly score (PASE) will be used to measure self-reported physical activity level. This valid and reliable self-report instrument measures the type and level of recreational and occupational physical activity in the previous week.
Change in knee joint proprioception from baseline
Knee joint proprioception will be measured using a knee joint repositioning task, previously used in those with OA to assess joint proprioception. Proprioception will be assessed in three randomly chosen target positions (15°, 30°, and 60° of knee flexion) while the participant is seated on an isokinetic dynamometer.
Change in muscle strength from baseline
Maximal concentric and eccentric muscle strength of the plantarflexors, quadriceps, and hamstrings will be measured using the same isokinetic dynamometer as for the knee joint repositioning task.
Change in knee joint range of motion from baseline
Range of motion will be measured using a goniometer, similar to other studies of knee OA. Participants will be asked to flex and extend their knee joint while supine.
Full Information
NCT ID
NCT02103907
First Posted
April 1, 2014
Last Updated
June 5, 2016
Sponsor
University of British Columbia
Collaborators
Arthritis Health Professions Association
1. Study Identification
Unique Protocol Identification Number
NCT02103907
Brief Title
Randomized Controlled Trial of Dynamic Balance Training in People With Knee Osteoarthritis
Official Title
The Effect of Dynamic Balance Training on Balance and Physical Function in Those With Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of British Columbia
Collaborators
Arthritis Health Professions Association
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
There is a high prevalence of falls in those with knee osteoarthritis (OA) compared to healthy older adults. Balance is a key element of function that allows individuals to maintain posture and respond to perturbations, and poor balance control, a risk factor for falls, has been noted in those with knee OA. There is a lack of research guiding treatment for balance deficits in knee OA, with interventions aimed at improving balance deficits in those with knee OA having mixed results. Targeted dynamic balance interventions in other patient populations have been shown to significantly improve dynamic balance control and physical function. If results similar to such populations can be achieved, such a program may produce a significant reduction in functional disability in the knee OA population and improve quality of life. The purpose of this study is to examine the effect of a 10-week targeted dynamic balance intervention on dynamic balance and physical function in people with knee OA. This will be a randomized controlled trial (RCT).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
balance, knee, osteoarthritis, physical function
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Wait list
Arm Type
No Intervention
Arm Description
Wait list control group. Participants will be placed on the wait list and asked to maintain their current routine and level of activity during the 10 week period. Control group participants will receive the dynamic balance training program in a single training session after the followup (second testing session at 10 weeks).
Arm Title
Treatment (balance training)
Arm Type
Experimental
Arm Description
Targeted dynamic balance training. Dynamic balance training will consist of progressive exercise training over three phases, with exercises emphasising dynamic balance control, muscle strength and proprioception. Exercises will be performed four times per week for ten weeks. Exercises will be taught and supervised by a trained kinesiologist. Difficulty of exercises will be increased progressively over time by increasing resistance, time of timed exercises, and distance of walking exercises. Exercises will be progressed to different exercises in each new phase (total 3 phases). Participants will complete six treatment sessions at the university (during weeks 1, 2, 3, 5, 7, and 9) that will be included in the total number of sessions per week. All other sessions will be performed at home.
Intervention Type
Other
Intervention Name(s)
Targeted dynamic balance training
Intervention Description
Participants in this study group will complete dynamic balance training exercises four times per week, for ten weeks. Exercise sessions at the university will last approximately one hour, and home exercise sessions will take approximately 30 minutes to complete. Exercises will emphasize dynamic balance control, muscle strength and proprioception and will be progressed over three phases during the ten weeks (with more difficult exercises phased in, and exercises that have been mastered phased out).
Primary Outcome Measure Information:
Title
Change in dynamic balance and mobility from baseline
Description
The Community Balance and Mobility Scale (CB&M) will be used to assess dynamic balance and mobility. The CB&M is a scale designed to assess dynamic balance and mobility and is administered by a trained assessor. The scale consists of 13 items including bending, walking, turning, and stair descent, with a maximum possible score of 96 and minimum score of 0. The scale has been validated and deemed reliable for use in the knee osteoarthritis population.
Time Frame
0, 10 weeks
Title
Change in self-reported physical function from baseline
Description
The Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) will be used to assess self-reported physical function. The WOMAC physical function subscale consists of 17 questions assessing physical function capabilities during activities of daily living.
Time Frame
0, 10 weeks
Secondary Outcome Measure Information:
Title
Change in knee pain from baseline
Description
Average pain over the previous week will be assessed using an 11-point numerical rating scale (0 = no pain; 10 = worst pain possible).
Time Frame
0, 10 weeks
Title
Change in fear of pain from baseline
Description
The Brief Fear of Movement Scale will be used to assess fear of pain. This scale is based on the widely used Tampa Scale of Kinesiophobia and contains 6 questions that evaluate fear of pain, movement and re-injury. The scale has been validated in individuals with OA.
Time Frame
0, 10 weeks
Title
Change in self-reported physical activity level from baseline
Description
The Physical Activity Scale for the Elderly score (PASE) will be used to measure self-reported physical activity level. This valid and reliable self-report instrument measures the type and level of recreational and occupational physical activity in the previous week.
Time Frame
0, 10 weeks
Title
Change in knee joint proprioception from baseline
Description
Knee joint proprioception will be measured using a knee joint repositioning task, previously used in those with OA to assess joint proprioception. Proprioception will be assessed in three randomly chosen target positions (15°, 30°, and 60° of knee flexion) while the participant is seated on an isokinetic dynamometer.
Time Frame
0, 10 weeks
Title
Change in muscle strength from baseline
Description
Maximal concentric and eccentric muscle strength of the plantarflexors, quadriceps, and hamstrings will be measured using the same isokinetic dynamometer as for the knee joint repositioning task.
Time Frame
0, 10 weeks
Title
Change in knee joint range of motion from baseline
Description
Range of motion will be measured using a goniometer, similar to other studies of knee OA. Participants will be asked to flex and extend their knee joint while supine.
Time Frame
0, 10 weeks
Other Pre-specified Outcome Measures:
Title
Ratio of number of exercise sessions attended to the maximum
Description
Adherence to the exercise program will be assessed by calculating the number of exercise sessions attended divided by the maximum number of sessions.
Time Frame
10 weeks
Title
Number of participants with adverse events
Description
Adverse events experienced due to the intervention (i.e. increased knee pain) will be recorded weekly by participants.
Time Frame
10 weeks
Title
Change in medication use
Description
Any change in pharmacological use by participants will be recorded.
Time Frame
10 weeks
Title
Change in co-interventions
Description
Other therapies that participants may be pursuing will be recorded.
Time Frame
10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age 50 - 80 years (to meet the American College of Rheumatology clinical definition of OA)
radiographically confirmed knee OA in the medial compartment of the tibiofemoral joint
predominance of pain/tenderness over the medial (inside) region of the knee
Exclusion Criteria:
articular cartilage degradation in the lateral tibiofemoral compartment greater than the medial
inflammatory arthritic condition
history of knee or hip replacement surgery
recent use of corticosteroids (oral or via injection, within last 6 months)
pain originating predominantly from the patellofemoral joint
inability to ambulate without a gait aid
non-English speaking
recent (within 6 months) arthroscopic knee surgery
significant hip or back pain (limits the ability to perform the testing)
Neurological, musculoskeletal or other condition that affects movement ability or balance (i.e. stroke, diabetes, Parkinson's, heart attack, multiple sclerosis, fibromyalgia)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael A Hunt, PT, PhD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Motion Analysis and Biofeedback Laboratory, The University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 1Z3
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
28279661
Citation
Takacs J, Krowchuk NM, Garland SJ, Carpenter MG, Hunt MA. Dynamic Balance Training Improves Physical Function in Individuals With Knee Osteoarthritis: A Pilot Randomized Controlled Trial. Arch Phys Med Rehabil. 2017 Aug;98(8):1586-1593. doi: 10.1016/j.apmr.2017.01.029. Epub 2017 Mar 6.
Results Reference
derived
Learn more about this trial
Randomized Controlled Trial of Dynamic Balance Training in People With Knee Osteoarthritis
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