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CompletedNCT02753634Updated Nov 29, 2016

An Innovative Mind-motor Exercise Approach to Osteoarthritis Treatment

An interventional study of Square-stepping exercise in Knee Osteoarthritis, sponsored by London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's. Completed. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2016-11-29.

Sponsored by London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
40 Years to 85 Years
Sex
All
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Study summary

Osteoarthritis (OA) is a growing burden in an aging society. There are few proven treatments and hence disability contributes to poor quality of life and direct/indirect costs to society. OA symptoms include both increased pain and reduced mobility. Strength training and aerobic exercise has been shown to improve symptoms in OA; however, the impact of targeted mobility and balance training in patients with osteoarthritis is unclear. The investigators propose a novel, low-impact exercise modality that improves balance and gait. The results of this research project should improve patient options and improve knowledge in OA management.

Read the detailed description

Patients with OA have increased fall risk, which can lead to reduced mobility and curtailment of daily activities. Patients with OA also show varied and altered mobility in a sit-to-stand test, suggesting that both poor lower limb strength and flexibility need to be addressed with targeted interventions in this population. Altered mobility is also associated with pain in patients with OA. The cause of decreased mobility and increased pain is often a result of body weight. In a 5-year follow-up study, classes of knee OA were identified as being associated with good, moderate or poor outcomes; characteristics of the poor outcomes class included high BMI, worse pain, >2 co-morbidities and avoidance of activities. Avoidance of activities is a particularly important outcome since this could lead to a downward spiral of decreased physical functioning, falls and further avoidance of activities.

Multiple studies have shown that increasing weight from normal to overweight or obese decreases mobility and increases pain in individuals with OA. This is a potential target for non-pharmacological therapies. For example, Messier et al., showed that a diet and exercise intervention designed to promote weight loss in overweight individuals with knee OA, improved knee compressive forces and function, reduced inflammatory marker IL-6, decreased pain and improved physical health-related quality of life over an 18-month period. This study demonstrated the important effects of weight loss and exercise on knee OA for overall health. In a recent review, the evidence was overwhelming regarding the use of exercise as a treatment of knee OA. Specifically, the literature demonstrates that strength training and aerobic exercise can improve outcomes, such as pain reduction and increased function, in patients with OA. Lifestyle interventions should be utilized in OA populations to help reduce pain, improve mobility and reduce fall risk.

Square-Stepping Exercise (SSE) was developed is a low-tech, low-intensity, novel form of exercise developed in Japan. SSE was originally designed to reduce fall risk in older adults. Participants watch, recognize, memorize and follow increasingly more difficult step patterns, which an instructor demonstrates on a 4 by 10 square-patterned mat. In older adult populations, Shigematsu and colleagues have found that SSE improves overall fitness and lower extremity functioning, as well as reduces fall risk, when compared to walking programs or strength and balance training. In combination with Shigematsu's research in Japan in healthy older adults, the investigators are aiming to provide a significant evidence base for SSE internationally and within varied populations, including older adults with osteoarthritis. In collaboration with Dr. Shigematsu, the investigators have executed SSE studies at the Canadian Centre for Activity and Aging in London, ON and most recently in Woodstock, ON. Preliminary evidence from our study at the Canadian Centre for Activity and Aging showed that over a 3-month training period, participants in our Exercise-Intervention (E-I) group (involving mind-motor exercise) improved their total balance scores, compared to an Exercise-Control (E-C) group.

SSE has not been tested in the OA population. This pilot study will add to the literature to determine whether it reduces pain and improves mobility as an additional non-pharmacological treatment for this population.

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Conditions studied

  • Knee Osteoarthritis

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03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 22 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's is the lead sponsor of 352 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Knee osteoarthritis

Exclusion criteria

Exclusion Criteria:

  • WOMAC less than 4
  • Use of braces
  • Uncontrolled hypertension
  • Significant psychiatric or psychotic disorder
  • Not able to attend 75% of sessions
  • Any other reason that would prevent participation
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
22 participants (actual)

Study arms

  • Experimental
    Square-stepping exercise Intervention

    Participant attend sessions 2 times per week for 24-weeks at a community location. An instructor demonstrated increasingly difficulty walking or stepping patterns across a gridded mat and participants are asked to try and remember and repeat the patterns. Social engagement is encouraged.

    Behavioral: Square-stepping exercise

  • No intervention
    Usual care wait-list control group

    This group will be invited to participate in square-stepping exercise after final assessments are completed.

Interventions

  • BehavioralSquare-stepping exercise

    Participants are asked to remember and repeat stepping patterns across a gridded mat as shown to them by an instructor.

    Also known as: Mind-motor exercise

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What researchers measure

Primary outcomes

  1. WOMAC Index

    self-report of knee pain for osteoarthritis

    Time frame: Change from baseline to 24-weeks

  2. WOMAC Index

    self-report of knee pain for osteoarthritis

    Time frame: Change from baseline to 12-weeks

Secondary outcomes

  1. 30 second Chair stand

    measures lower limb functional strength

    Time frame: change from baseline to 24-weeks

  2. 30 second Chair stand

    measures lower limb functional strength

    Time frame: change from baseline to 12-weeks

  3. Timed up and Go test

    measures functional fitness

    Time frame: change from baseline to 24-weeks

  4. Timed up and Go test

    measures functional fitness

    Time frame: change from baseline to 12-weeks

  5. Fullerton Advanced Balance Scale

    a single scale used to measure static and dynamic balance

    Time frame: change from baseline to 24-weeks

  6. Fullerton Advanced Balance Scale

    a single scale used to measure static and dynamic balance

    Time frame: change from baseline to 12-weeks

  7. 6 metre walk test

    measures usual walking speed

    Time frame: change from baseline to 24-weeks

  8. 6 metre walk test

    measures usual walking speed

    Time frame: change from baseline to 12-weeks

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 29, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02753634
Lead sponsor
London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's
Collaborators
University of Western Ontario, Canada
Responsible party
Sponsor
First posted
Apr 28, 2016
Start date
Apr 2015
Primary completion
Jun 2016
Completion
Jun 2016
Last update
Nov 29, 2016

Study contacts

Robert Petrella, MD, PhD
principal investigator · Western University, Canada

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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