Gait Retraining for Runners With Knee Osteoarthritis

Osteoarthritis, Knee Clinical Trial

Official title:

The Effects of Gait Retraining in Runners With Knee Osteoarthritis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03314428
• Other study ID #: H17-01228
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: July 2025

Study information

• Verified date: November 2023
• Source: University of British Columbia
• Contact: Jean-Francois Esculier, PT, PhD
• Phone: 604-822-7948
• Email: jean-francois.esculier[@]ubc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 18
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Behavioral:
• Gait retraining
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.

Locations

Country	Name	City	State
Canada	Robert H.N. Ho Research Centre	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Compliance with gait retraining change	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.	During Week 1, 2, 3 and 4 of the retraining program
Other	Numeric pain rating scale for usual pain change	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
Other	Numeric pain rating scale for worst pain change	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
Primary	Knee Osteoarthritis Outcome Score (KOOS) change	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.	Baseline, 2 weeks, 4 weeks, 2 months, 3 months, 4 months
Primary	Peak knee adduction moment impulse change	Validated surrogate measure of knee joint loading during movement. Expressed as Nm/kg*sec	Baseline, 4 weeks, 4 months
Secondary	Numerical pain rating scale for pain during running change	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.	Baseline, 2 weeks, 4 weeks, 2 months, 3 months, 4 months
Secondary	Step rate change	Number of steps taken during one minute of running.	Baseline, 4 weeks, 4 months
Secondary	Peak knee flexion moment impulse change	Validated surrogate measure of knee joint loading during running. Expressed as Nm/kg*sec	Baseline, 4 weeks, 4 months