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Knee OsteoarthritisNCT02753634

An Innovative Mind-motor Exercise Approach to Osteoarthritis Treatment

A study testing Square-stepping exercise in people with Knee Osteoarthritis, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 85 years
Conditions the study is for
Knee Osteoarthritis
What is being tested?
Square-stepping exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
No sites listed yet
Study dates
Apr 2015to Jun 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Knee osteoarthritis

Who cannot join

  • 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

About this study

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.

Being tested
Square-stepping exercise
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Square-stepping exerciseBehavioural

    Also called Mind-motor exercise

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

Study groups in NCT02753634
Study groupRoleWhat they receive
Square-stepping exercise InterventionExperimentalParticipant 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.
Receives: Behavioral: Square-stepping exercise
Usual care wait-list control groupNo interventionThis group will be invited to participate in square-stepping exercise after final assessments are completed.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. WOMAC Index

    self-report of knee pain for osteoarthritis

    Measured: Change from baseline to 24-weeks

  2. WOMAC Index

    self-report of knee pain for osteoarthritis

    Measured: Change from baseline to 12-weeks

Secondary outcomes (8)
  1. 30 second Chair stand

    measures lower limb functional strength

    Measured: change from baseline to 24-weeks

  2. 30 second Chair stand

    measures lower limb functional strength

    Measured: change from baseline to 12-weeks

  3. Timed up and Go test

    measures functional fitness

    Measured: change from baseline to 24-weeks

  4. Timed up and Go test

    measures functional fitness

    Measured: change from baseline to 12-weeks

  5. Fullerton Advanced Balance Scale

    a single scale used to measure static and dynamic balance

    Measured: change from baseline to 24-weeks

  6. Fullerton Advanced Balance Scale

    a single scale used to measure static and dynamic balance

    Measured: change from baseline to 12-weeks

  7. 6 metre walk test

    measures usual walking speed

    Measured: change from baseline to 24-weeks

  8. 6 metre walk test

    measures usual walking speed

    Measured: change from baseline to 12-weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2016 (estimated)
  2. Study startApr 2015
  3. Primary completionJun 2016
  4. Study completionJun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02753634
Sponsor's protocol ID
OA SSE
Status last verified
Mar 2016
First submitted
22 Mar 2016
Last updated
29 Nov 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Square-stepping exercise in people with Knee Osteoarthritis, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

WOMAC Index (time frame: Change from baseline to 24-weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2016.

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