- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02753634
An Innovative Mind-motor Exercise Approach to Osteoarthritis Treatment
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Knee osteoarthritis
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Participants are asked to remember and repeat stepping patterns across a gridded mat as shown to them by an instructor.
Other Names:
|
No Intervention: Usual care wait-list control group
This group will be invited to participate in square-stepping exercise after final assessments are completed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
WOMAC Index
Time Frame: Change from baseline to 24-weeks
|
self-report of knee pain for osteoarthritis
|
Change from baseline to 24-weeks
|
WOMAC Index
Time Frame: Change from baseline to 12-weeks
|
self-report of knee pain for osteoarthritis
|
Change from baseline to 12-weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
30 second Chair stand
Time Frame: change from baseline to 24-weeks
|
measures lower limb functional strength
|
change from baseline to 24-weeks
|
30 second Chair stand
Time Frame: change from baseline to 12-weeks
|
measures lower limb functional strength
|
change from baseline to 12-weeks
|
Timed up and Go test
Time Frame: change from baseline to 24-weeks
|
measures functional fitness
|
change from baseline to 24-weeks
|
Timed up and Go test
Time Frame: change from baseline to 12-weeks
|
measures functional fitness
|
change from baseline to 12-weeks
|
Fullerton Advanced Balance Scale
Time Frame: change from baseline to 24-weeks
|
a single scale used to measure static and dynamic balance
|
change from baseline to 24-weeks
|
Fullerton Advanced Balance Scale
Time Frame: change from baseline to 12-weeks
|
a single scale used to measure static and dynamic balance
|
change from baseline to 12-weeks
|
6 metre walk test
Time Frame: change from baseline to 24-weeks
|
measures usual walking speed
|
change from baseline to 24-weeks
|
6 metre walk test
Time Frame: change from baseline to 12-weeks
|
measures usual walking speed
|
change from baseline to 12-weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Robert Petrella, MD, PhD, Western University, Canada
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OA SSE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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