NCT03314428

Brief 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.

Trial Health

50
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
2mo left

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
withdrawn

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 Progress85%
Jul 2025Jul 2026

First Submitted

Initial submission to the registry

October 13, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 19, 2017

Completed
7.7 years until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

March 6, 2026

Status Verified

March 1, 2026

Enrollment Period

1 year

First QC Date

October 13, 2017

Last Update Submit

March 4, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (3)

  • Numerical pain rating scale for pain during running change

    Baseline, 2 weeks, 4 weeks, 2 months, 3 months, 4 months

  • Step rate change

    Baseline, 4 weeks, 4 months

  • Peak knee flexion moment impulse change

    Baseline, 4 weeks, 4 months

Other Outcomes (3)

  • Compliance with gait retraining change

    During Week 1, 2, 3 and 4 of the retraining program

  • Numeric pain rating scale for usual pain change

    Baseline, 2 weeks, 4 weeks, 2 months, 3 months, 4 months

  • Numeric pain rating scale for worst pain change

    Baseline, 2 weeks, 4 weeks, 2 months, 3 months, 4 months

Study Arms (1)

Gait retraining

EXPERIMENTAL

Runners will be taught how to modify their running gait through multiple laboratory sessions and in-field training.

Behavioral: Gait retraining

Interventions

Gait retrainingBEHAVIORAL

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.

Gait retraining

Eligibility Criteria

Age40 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Robert H.N. Ho Research Centre

Vancouver, British Columbia, V5Z 1M9, Canada

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Michael A Hunt, PT, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Data will be analyzed by an assessor blinded to date of data collection for each testing session. Following data collection, a researcher not involved with data collection or analysis will re-code data timepoints to ensure that the assessor is unaware of the timepoint each datapoint was obtained.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single Group cohort study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 13, 2017

First Posted

October 19, 2017

Study Start

July 1, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

March 6, 2026

Record last verified: 2026-03

Locations