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Study disrupted due to COVID-19. Interim data analyses in progress.
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| Name | Class |
|---|---|
| Boston University | OTHER |
| University of Delaware | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MCG - Mindful Walking | Experimental | Participants will be trained in mindful walking technique |
|
| SCG - Education and Self-Care | Active Comparator | Participants will receive education in self-management of knee OA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MCG | Behavioral | Community-based in person group training n mindful walking over 11 sessions in 6-months+ Activity monitor with feedback on activity levels |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Arthritis Self Efficacy Scale (ASES) | Patient reported outcome | Change from baseline to 6-months |
| Five Facet Mindfulness Questionnaire (FFMQ) | Patient reported outcome |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deepak Kumar, PT, PhD | Boston University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston University | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37778085 | Derived | Lee S, Neogi T, Costello KE, Senderling B, Stefanik JJ, Frey-Law L, Kumar D. Association of mechanical temporal summation of pain with muscle co-contraction during walking in people with knee osteoarthritis. Clin Biomech (Bristol). 2023 Dec;110:106105. doi: 10.1016/j.clinbiomech.2023.106105. Epub 2023 Sep 22. |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| SCG | Behavioral | 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 |
|
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 |
| Change from baseline to 6-months |
| Multidimensional Assessment of Interoceptive Awareness (MAIA) questionnaire | Patient reported outcome | Change from baseline to 6-months |
| 30 second chair stand test (in counts) | Number of time a participant can stand from a chair | Change from baseline to 6-months |
| 40 meter fast paced walk test (in seconds) | Time taken to cover 40 meters while walking at a fast pace | Change from baseline to 6-months |
| Stair Climbing Test (in seconds) | Time taken to ascend and descend a set of stairs | Change from baseline to 6-months |
| Knee cartilage composition | MRI t1rho and t2 relaxation times | Change from baseline to 6-months |
| Pain sensitization | Pressure pain threshold, Temporal summation, and conditioned pain modulation | Change from baseline to 6-months |
| D012216 |
| Rheumatic Diseases |
| D001519 | Behavior |