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

NCT02103907 | Completed

• 2 other identifiers: H14-00587AHPA-TAS- 14-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Knee Osteoarthritis

Keywords

balance; knee; osteoarthritis; physical function

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Change in knee pain from baseline

  0, 10 weeks

• Change in fear of pain from baseline

  0, 10 weeks

• Change in self-reported physical activity level from baseline

  0, 10 weeks

• Change in knee joint proprioception from baseline

  0, 10 weeks

• Change in muscle strength from baseline

  0, 10 weeks

Other Outcomes (4)

• Ratio of number of exercise sessions attended to the maximum

  10 weeks

• Number of participants with adverse events

  10 weeks

• Change in medication use

  10 weeks

Study Arms (2)

Wait list

NO INTERVENTION

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).

Treatment (balance training)

EXPERIMENTAL

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

Interventions

Targeted dynamic balance training OTHER

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).

Treatment (balance training)

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of British Columbia: lead
• Arthritis Health Professions Association: collaborator

Study Sites (1)

Motion Analysis and Biofeedback Laboratory, The University of British Columbia

Vancouver, British Columbia, V6T 1Z3, Canada

Location

Related Publications (1)

• 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.

  PMID: 28279661 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Michael A Hunt, PT, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2014
• First Posted: April 4, 2014
• Study Start: June 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: June 7, 2016

Record last verified: 2016-06

Locations

CA (1)