Knee Osteoarthritis
Conditions
Keywords
physical activity, gait, biomechanics, mindfulness
Brief summary
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
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.
Interventions
BEHAVIORALMCG
Community-based in person group training n mindful walking over 11 sessions in 6-months+ Activity monitor with feedback on activity levels
BEHAVIORALSCG
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
Sponsors
Boston University Charles River Campus
Boston University
University of Delaware
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence (in %) | 6-months | Measured as % of in-person training sessions attended by participants |
| Retention (in %) | 6-months | Measured as the % of participants returning for the post-intervention assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Medial knee contact force during walking (in Newton) | Change from baseline to 6-months | Medial knee contact force derived using an EMG-Driven musculoskeletal model |
| Average Daily Activity Count | Change from baseline to 6-months | Measured using an activity monitor worn by the participants |
| Knee injury and Osteoarthritis Outcome Score (KOOS) Pain Subscale | Change from baseline to 6-months | Patient-reported outcome |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDeepak Kumar, PT, PhD
Boston University
Outcome results
None listed