Improving Walking Quality and Quantity in Osteoarthritis (IWALQQ-OA)

Study Overview
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Brief Summary
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This study evaluates the feasibility of a mindful walking intervention for management of knee osteoarthritis. Participants will be randomly assigned to receive one of two interventions i.e. mindful walking intervention or a self-care intervention.

Detailed Description
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People with knee osteoarthritis have low levels of physical activity, especially walking activity. They also walk with abnormal walking biomechanics that are associated with greater knee loading. Therefore, it is important to increase the levels of walking activity in people with knee osteoarthritis, but also change their walking patterns to reduce knee loading. This study will last 12 months and participants will be randomized into 2 groups. For the first 6-months, half of the participants will attend sessions at a community location that include training in mindful walking technique. The other half will meet for the same frequency and duration at a community location for education on osteoarthritis and its management (focusing on symptom management, importance of physical activity, weight management, etc.). Both groups will also receive a wrist-worn activity monitor and a smartphone application that they will use throughout the study. After 6-months all participants will be allowed to practice on their own. All participants will complete gait analysis, knee MRI, questionnaires, physical function assessment at baseline and at 6-months. All participants will also complete questionnaires at 3,9, and 12 months. Weekly physical activity and knee pain data will be collected using the mobile health technology for 12- months.

Official Title
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Improving Walking Quality and Quantity in Osteoarthritis (IWALQQ-OA): A Feasibility Study

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Behavioral: MCG
* Behavioral: SCG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 50-80 years BMI ≤40 kg/m2 Meet American College of Rheumatology clinical and/or clinical+radiographic criteria for knee osteoarthritis Knee pain score ≥ 4 during last week Predominantly medial knee pain Predominantly medial knee radiographic osteoarthritis with or without radiographic patellofemoral osteoarthritis Ability to ambulate for a minimum of 20 minutes, without any assistive device Available for the study duration Own a smartphone Can speak and understand English Exclusion Criteria: Contraindications to exercise Using orthotics for knee pain such as knee braces, wedge insoles Knee injection in previous 3-months Currently receiving physical therapy for knee pain Planning major treatment for knee pain (e.g., physical therapy, surgery) in next 6 months Self-reported joint diseases like rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, gout, etc. Self-reported total joint replacement in any lower extremity joint Self-reported neurological conditions like stroke, Parkinson's disease, etc. Self-reported muscular disease like muscle dystrophy Self-reported musculoskeletal or neurologic conditions that affect gait.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MCG - Mindful Walking<br>Participants will be trained in mindful walking technique | Behavioral: MCG<br>* Community-based in person group training n mindful walking over 11 sessions in 6-months+ Activity monitor with feedback on activity levels<br>|
| Active Comparator: SCG - Education and Self-Care<br>Participants will receive education in self-management of knee OA | Behavioral: SCG<br>* Community-based in person group education in management of knee osteoarthritis (importance of physical activity, weight management, etc.) over 11 sessions in 6 months + Activity monitor with feedback on activity levels<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence (in %) | Measured as % of in-person training sessions attended by participants | 6-months | 
| Retention (in %) | Measured as the % of participants returning for the post-intervention assessment | 6-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medial knee contact force during walking (in Newton) | Medial knee contact force derived using an EMG-Driven musculoskeletal model | Change from baseline to 6-months | 
| Average Daily Activity Count | Measured using an activity monitor worn by the participants | Change from baseline to 6-months | 
| Knee injury and Osteoarthritis Outcome Score (KOOS) Pain Subscale | Patient-reported outcome | Change from baseline to 6-months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mindfulness, physical activity, gait, biomechanics