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Gait Retraining for Runners With Knee Osteoarthritis

Primary Purpose

Osteoarthritis, Knee

Status

Recruiting

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Gait retraining

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Robert H.N. Ho Research CentreRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gait retraining

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Peak knee adduction moment impulse change

Validated surrogate measure of knee joint loading during movement. Expressed as Nm/kg*sec

Secondary Outcome Measures

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.

Step rate change

Number of steps taken during one minute of running.

Peak knee flexion moment impulse change

Validated surrogate measure of knee joint loading during running. Expressed as Nm/kg*sec

Full Information

NCT ID

NCT03314428

First Posted

October 13, 2017

Last Updated

May 16, 2022

Sponsor

University of British Columbia

1. Study Identification

Unique Protocol Identification Number

NCT03314428

Brief Title

Gait Retraining for Runners With Knee Osteoarthritis

Official Title

The Effects of Gait Retraining in Runners With Knee Osteoarthritis

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Recruiting

Study Start Date

April 16, 2018 (Actual)

Primary Completion Date

January 2024 (Anticipated)

Study Completion Date

January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of British Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis, Knee

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Single Group cohort study

Masking

None (Open Label)

Masking Description

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.

Allocation

N/A

Enrollment

18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Gait retraining

Arm Type

Experimental

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Gait retraining

Intervention Description

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.

Primary Outcome Measure Information:

Title

Knee Osteoarthritis Outcome Score (KOOS) change

Description

Time Frame

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

Title

Peak knee adduction moment impulse change

Description

Validated surrogate measure of knee joint loading during movement. Expressed as Nm/kg*sec

Time Frame

Baseline, 4 weeks, 4 months

Secondary Outcome Measure Information:

Title

Numerical pain rating scale for pain during running change

Description

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.

Time Frame

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

Title

Step rate change

Description

Number of steps taken during one minute of running.

Time Frame

Baseline, 4 weeks, 4 months

Title

Peak knee flexion moment impulse change

Description

Validated surrogate measure of knee joint loading during running. Expressed as Nm/kg*sec

Time Frame

Baseline, 4 weeks, 4 months

Other Pre-specified Outcome Measures:

Title

Compliance with gait retraining change

Description

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.

Time Frame

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

Title

Numeric pain rating scale for usual pain change

Description

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.

Time Frame

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

Title

Numeric pain rating scale for worst pain change

Description

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.

Time Frame

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jean-Francois Esculier, PT, PhD

Phone

604-822-7948

jean-francois.esculier@ubc.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Michael A Hunt, PT, PhD

Phone

604-822-7948

michael.hunt@ubc.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael A Hunt, PT, PhD

Organizational Affiliation

University of British Columbia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Robert H.N. Ho Research Centre

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 1M9

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Danmei Liu, PhD

danmei.liu@hiphealth.ca

12. IPD Sharing Statement

Learn more about this trial

Gait Retraining for Runners With Knee Osteoarthritis

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