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Completed

NCT Number: NCT02103907

Randomized Controlled Trial of Dynamic Balance Training in People 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).

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Motion Analysis and Biofeedback Laboratory, The University of British Columbia

Vancouver, British Columbia, V6T 1Z3, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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).

Primary outcomes

  1. Change in dynamic balance and mobility from baseline

    Time frame: 0, 10 weeks

    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.

  2. Change in self-reported physical function from baseline

    Time frame: 0, 10 weeks

    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 outcomes

  1. Change in knee pain from baseline

    Time frame: 0, 10 weeks

    Average pain over the previous week will be assessed using an 11-point numerical rating scale (0 = no pain; 10 = worst pain possible).

  2. Change in fear of pain from baseline

    Time frame: 0, 10 weeks

    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.

  3. Change in self-reported physical activity level from baseline

    Time frame: 0, 10 weeks

    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.

  4. Change in knee joint proprioception from baseline

    Time frame: 0, 10 weeks

    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.

  5. Change in muscle strength from baseline

    Time frame: 0, 10 weeks

    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.

  6. Change in knee joint range of motion from baseline

    Time frame: 0, 10 weeks

    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.

Other outcomes

  1. Ratio of number of exercise sessions attended to the maximum

    Time frame: 10 weeks

    Adherence to the exercise program will be assessed by calculating the number of exercise sessions attended divided by the maximum number of sessions.

  2. Number of participants with adverse events

    Time frame: 10 weeks

    Adverse events experienced due to the intervention (i.e. increased knee pain) will be recorded weekly by participants.

  3. Change in medication use

    Time frame: 10 weeks

    Any change in pharmacological use by participants will be recorded.

  4. Change in co-interventions

    Time frame: 10 weeks

    Other therapies that participants may be pursuing will be recorded.

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Arthritis Health Professions Association

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 4, 2014
Registry last updated
Jun 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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