Improving Walking Quality and Quantity in Osteoarthritis (IWALQQ-OA)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: MCG - Mindful Walking Participants will be trained in mindful walking technique |
Behavioral: MCG
Community-based in person group training n mindful walking over 11 sessions in 6-months+ Activity monitor with feedback on activity levels
|
| Active Comparator: SCG - Education and Self-Care Participants will receive education in self-management of knee OA |
Behavioral: SCG
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
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Other Outcome Measures
- Arthritis Self Efficacy Scale (ASES) [Change from baseline to 6-months]
Patient reported outcome
- Five Facet Mindfulness Questionnaire (FFMQ) [Change from baseline to 6-months]
Patient reported outcome
- Multidimensional Assessment of Interoceptive Awareness (MAIA) questionnaire [Change from baseline to 6-months]
Patient reported outcome
- 30 second chair stand test (in counts) [Change from baseline to 6-months]
Number of time a participant can stand from a chair
- 40 meter fast paced walk test (in seconds) [Change from baseline to 6-months]
Time taken to cover 40 meters while walking at a fast pace
- Stair Climbing Test (in seconds) [Change from baseline to 6-months]
Time taken to ascend and descend a set of stairs
- Knee cartilage composition [Change from baseline to 6-months]
MRI t1rho and t2 relaxation times
- Pain sensitization [Change from baseline to 6-months]
Pressure pain threshold, Temporal summation, and conditioned pain modulation
Eligibility Criteria
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:
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Contraindications to exercise
-
Using orthotics for knee pain such as knee braces, wedge insoles
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Knee injection in previous 3-months
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Currently receiving physical therapy for knee pain
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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.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Boston University | Boston | Massachusetts | United States | 02215 |
Sponsors and Collaborators
- Boston University Charles River Campus
- Boston University
- University of Delaware
Investigators
- Principal Investigator: Deepak Kumar, PT, PhD, Boston University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 4428E