An Innovative Mind-motor Exercise Approach to Osteoarthritis Treatment
1 other identifier
interventional
22
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable knee-osteoarthritis
Started Apr 2015
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 22, 2016
CompletedFirst Posted
Study publicly available on registry
April 28, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedNovember 29, 2016
March 1, 2016
1.2 years
March 22, 2016
November 25, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
WOMAC Index
self-report of knee pain for osteoarthritis
Change from baseline to 24-weeks
WOMAC Index
self-report of knee pain for osteoarthritis
Change from baseline to 12-weeks
Secondary Outcomes (8)
30 second Chair stand
change from baseline to 24-weeks
30 second Chair stand
change from baseline to 12-weeks
Timed up and Go test
change from baseline to 24-weeks
Timed up and Go test
change from baseline to 12-weeks
Fullerton Advanced Balance Scale
change from baseline to 24-weeks
- +3 more secondary outcomes
Study Arms (2)
Square-stepping exercise Intervention
EXPERIMENTALParticipant 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.
Usual care wait-list control group
NO INTERVENTIONThis group will be invited to participate in square-stepping exercise after final assessments are completed.
Interventions
Participants are asked to remember and repeat stepping patterns across a gridded mat as shown to them by an instructor.
Eligibility Criteria
You may qualify if:
- Knee osteoarthritis
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Petrella, MD, PhD
Western University, Canada
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2016
First Posted
April 28, 2016
Study Start
April 1, 2015
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
November 29, 2016
Record last verified: 2016-03
Data Sharing
- IPD Sharing
- Will not share