Clinical trial NCT03064139: Improving Walking Quality and Quantity in Osteoarthritis (IWALQQ-OA)
Official title: Improving Walking Quality and Quantity in Osteoarthritis (IWALQQ-OA): A Feasibility Study
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: physical activity
gait
biomechanics
mindfulness
Lead sponsor: Boston University Charles River Campus
Sponsor class: OTHER
Collaborators: name: Boston University
name: University of Delaware
First posted: 2017-02-24
Enrollment: 62
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Adherence (in %)
timeFrame: 6-months
measure: Retention (in %)
timeFrame: 6-months
Secondary outcomes:
measure: Medial knee contact force during walking (in Newton)
timeFrame: Change from baseline to 6-months
measure: Average Daily Activity Count
timeFrame: Change from baseline to 6-months
measure: Knee injury and Osteoarthritis Outcome Score (KOOS) Pain Subscale
timeFrame: Change from baseline to 6-months
Other outcomes:
measure: Arthritis Self Efficacy Scale (ASES)
timeFrame: Change from baseline to 6-months
measure: Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: Change from baseline to 6-months
measure: Multidimensional Assessment of Interoceptive Awareness (MAIA) questionnaire
timeFrame: Change from baseline to 6-months
measure: 30 second chair stand test (in counts)
timeFrame: Change from baseline to 6-months
measure: 40 meter fast paced walk test (in seconds)
timeFrame: Change from baseline to 6-months
measure: Stair Climbing Test (in seconds)
timeFrame: Change from baseline to 6-months
measure: Knee cartilage composition
timeFrame: Change from baseline to 6-months
measure: Pain sensitization
timeFrame: Change from baseline to 6-months
Locations:
city: Boston
country: United States
facility: Boston University
state: Massachusetts
Study officials:
affiliation: Boston University
name: Deepak Kumar, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: