Clinical trial NCT03314428: Gait Retraining for Runners with Knee Osteoarthritis
Official title: The Effects of Gait Retraining in Runners with Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2017-10-19
Enrollment: 18
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group cohort study
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Knee Osteoarthritis Outcome Score (KOOS) change
timeFrame: Baseline, 2 weeks, 4 weeks, 2 months, 3 months, 4 months
measure: Peak knee adduction moment impulse change
timeFrame: Baseline, 4 weeks, 4 months
Secondary outcomes:
measure: Numerical pain rating scale for pain during running change
timeFrame: Baseline, 2 weeks, 4 weeks, 2 months, 3 months, 4 months
measure: Step rate change
timeFrame: Baseline, 4 weeks, 4 months
measure: Peak knee flexion moment impulse change
timeFrame: Baseline, 4 weeks, 4 months
Other outcomes:
measure: Compliance with gait retraining change
timeFrame: During Week 1, 2, 3 and 4 of the retraining program
measure: Numeric pain rating scale for usual pain change
timeFrame: Baseline, 2 weeks, 4 weeks, 2 months, 3 months, 4 months
measure: Numeric pain rating scale for worst pain change
timeFrame: Baseline, 2 weeks, 4 weeks, 2 months, 3 months, 4 months
Locations:
city: Vancouver
country: Canada
facility: Robert H.N. Ho Research Centre
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Michael A Hunt, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: