- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03314428
Gait Retraining for Runners With Knee Osteoarthritis
November 27, 2023 updated by: Michael Hunt, University of British Columbia
The Effects of Gait Retraining in Runners With Knee Osteoarthritis
Tibiofemoral osteoarthritis (TFOA) is highly prevalent in older adults, and often causes symptoms and functional limitations.
Physical activity is widely advocated in people with TFOA, and running is an easy and accessible activity that provides many benefits on general health.
However, running induces high knee loads, which could potentially contribute to symptoms of runners with TFOA.
Previous studies have suggested that running gait modifications can help in decreasing symptoms and knee loading in runners with knee conditions.
Yet, no study has been conducted in runners with TFOA.
This intervention study will investigate the effects of a 4-week running gait retraining program on symptoms and running biomechanics in runners with TFOA.
We hypothesize that running modifications will decrease symptoms, improve function and reduce knee loading.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
18
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Michael A Hunt, PT, PhD
- Phone Number: 604-822-7948
- Email: michael.hunt@ubc.ca
Study Contact Backup
- Name: Jean-Francois Esculier, PT, PhD
- Phone Number: 604-822-7948
- Email: jean-francois.esculier@ubc.ca
Study Locations
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 1M9
- Robert H.N. Ho Research Centre
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Contact:
- Danmei Liu, PhD
- Email: danmei.liu@hiphealth.ca
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- TFOA of Grade 2 (mild) or 3 (moderate) on the Kellgren and Lawrence scale
- report knee pain greater than or equal to 3/10 on a numerical pain rating scale (0-10) during most days of the previous month
- run at least 10 km per week for a minimum of 6 months
- declare being comfortable running on a treadmill for at least 30 minutes
Exclusion Criteria:
- history of traumatic knee injury
- neurological or inflammatory arthritic condition
- cardiovascular or cardiopulmonary disease preventing from safely performing moderate intensity running
- presence of any lower limb condition affecting running (other than TFOA)
- use of any oral or injected corticosteroids or viscosupplementation in the previous six months
- regular use of non-steroidal anti-inflammatory drugs, analgesics or knee unloading bracing devices before, during or after running
- non-English speaking
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Gait retraining
Runners will be taught how to modify their running gait through multiple laboratory sessions and in-field training.
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Over a 4-week period, runners will be asked to increase their step rate to reduce knee loading during running.
Specifically, they will have to increase their preferred step rate by 10% during weekly laboratory running sessions as well as during habitual running training.
In the laboratory, runners will be provided with live visual/auditory biofeedback on step rate and asked to target a specific value representing 110% or preferred step rate.
During their individual running sessions, runners will be wearing a GPS-enabled watch that will provide feedback on live step rate, and they will be asked to maintain the same value as in the laboratory.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Knee Osteoarthritis Outcome Score (KOOS) change
Time Frame: Baseline, 2 weeks, 4 weeks, 2 months, 3 months, 4 months
|
Validated questionnaire on symptoms and functional limitations related to knee osteoarthritis.
The score is expressed in percentage (0-100), with 0 representing extreme knee problems and 100 representing no knee problems.
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Baseline, 2 weeks, 4 weeks, 2 months, 3 months, 4 months
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Peak knee adduction moment impulse change
Time Frame: Baseline, 4 weeks, 4 months
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Validated surrogate measure of knee joint loading during movement.
Expressed as Nm/kg*sec
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Baseline, 4 weeks, 4 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numerical pain rating scale for pain during running change
Time Frame: Baseline, 2 weeks, 4 weeks, 2 months, 3 months, 4 months
|
Validated scale ranging from 0 (no pain) to 10 (worst imaginable pain), in which participants rate their worst level of pain during running over the previous week.
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Baseline, 2 weeks, 4 weeks, 2 months, 3 months, 4 months
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Step rate change
Time Frame: Baseline, 4 weeks, 4 months
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Number of steps taken during one minute of running.
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Baseline, 4 weeks, 4 months
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Peak knee flexion moment impulse change
Time Frame: Baseline, 4 weeks, 4 months
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Validated surrogate measure of knee joint loading during running.
Expressed as Nm/kg*sec
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Baseline, 4 weeks, 4 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Compliance with gait retraining change
Time Frame: During Week 1, 2, 3 and 4 of the retraining program
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Compliance with instructions on step rate will be measured through data collected with the provided watch and a logbook.
We will also monitor weekly running distance during the course of the study.
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During Week 1, 2, 3 and 4 of the retraining program
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Numeric pain rating scale for usual pain change
Time Frame: Baseline, 2 weeks, 4 weeks, 2 months, 3 months, 4 months
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Validated scale ranging from 0 (no pain) to 10 (worst imaginable pain), in which participants rate their level of pain during their usual daily activities over the previous week.
|
Baseline, 2 weeks, 4 weeks, 2 months, 3 months, 4 months
|
Numeric pain rating scale for worst pain change
Time Frame: Baseline, 2 weeks, 4 weeks, 2 months, 3 months, 4 months
|
Validated scale ranging from 0 (no pain) to 10 (worst imaginable pain), in which participants rate their worst level of pain over the previous week.
|
Baseline, 2 weeks, 4 weeks, 2 months, 3 months, 4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michael A Hunt, PT, PhD, University of British Columbia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
January 1, 2024
Primary Completion (Estimated)
July 1, 2025
Study Completion (Estimated)
July 1, 2025
Study Registration Dates
First Submitted
October 13, 2017
First Submitted That Met QC Criteria
October 17, 2017
First Posted (Actual)
October 19, 2017
Study Record Updates
Last Update Posted (Actual)
November 29, 2023
Last Update Submitted That Met QC Criteria
November 27, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H17-01228
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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