Randomized Controlled Trial of Dynamic Balance Training in People With Knee Osteoarthritis

The Effect of Dynamic Balance Training on Balance and Physical Function in Those With Knee Osteoarthritis

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).

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Other: Targeted dynamic balance training

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6T 1Z3
      • Motion Analysis and Biofeedback Laboratory, The University of British Columbia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Wait list; 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).
Experimental: Treatment (balance training); 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.	Other: Targeted dynamic balance training; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	0, 10 weeks
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.	0, 10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	0, 10 weeks
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.	0, 10 weeks
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.	0, 10 weeks
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.	0, 10 weeks
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.	0, 10 weeks
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.	0, 10 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ratio of number of exercise sessions attended to the maximum	Adherence to the exercise program will be assessed by calculating the number of exercise sessions attended divided by the maximum number of sessions.	10 weeks
Number of participants with adverse events	Adverse events experienced due to the intervention (i.e. increased knee pain) will be recorded weekly by participants.	10 weeks
Change in medication use	Any change in pharmacological use by participants will be recorded.	10 weeks
Change in co-interventions	Other therapies that participants may be pursuing will be recorded.	10 weeks

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: Arthritis Health Professions Association
• Investigators: Principal Investigator: Michael A Hunt, PT, PhD, University of British Columbia

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: April 1, 2014
• First Submitted That Met QC Criteria: April 1, 2014
• First Posted (Estimate): April 4, 2014

Study Record Updates

• Last Update Posted (Estimate): June 7, 2016
• Last Update Submitted That Met QC Criteria: June 5, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: osteoarthritis; knee; physical function; balance
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: H14-00587; AHPA-TAS- 14-001 (Other Grant/Funding Number: AHPA/The Arthritis Society)