Delaware Physical Exercise and Activity for Knee Osteoarthritis

Study Overview
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Brief Summary
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The objective of this project is to examine the efficacy of an innovative Telehealth Physical Therapy (PT) program for adults with knee osteoarthritis (OA) to increase physical activity over 12 weeks in adults with knee OA compared to a control group receiving web-based resources about knee OA. One hundred individuals with knee osteoarthritis (OA), who are over the age of 45, and are also looking to move more, will be randomized into a brief or expanded intervention group. The brief intervention includes an online, guided video orientation from a physical therapist to web resources for strengthening exercises, physical activity, and pain management strategies for knee OA. The expanded program includes up to 5 online consultations with a physical therapist over a 12-week period who will prescribe strengthening exercises, physical activity goals, and pain management strategies for knee OA.

Detailed Description
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Delaware PEAK (Physical therapy Exercise and Activity for Knee osteoarthritis) is a delivered remotely by a physical therapist over 5 one-on-one video conference (Zoom Platform) consultations lasting 45 to 60 minutes each over 12 weeks. Each consultation focuses on strengthening exercises, physical activity goals, and education to debunk common OA-related myths and misconceptions. Delaware PEAK utilizes a well-established behavioral counseling method, Motivational Interviewing, to increase self-efficacy (confidence) related to exercise, while delivering all aspects of the intervention. The objective of this project is to examine the efficacy of Delaware PEAK to increase physical activity in adults with knee OA compared to a control group receiving web-based resources about knee OA and exercise. The rationale for our study is that there is a need to examine whether PEAK can directly target the mismatch between OA recommendations and practice patterns. Our central hypothesis is that Delaware PEAK will increase physical activity and will increase the belief that exercise is helpful and not harmful, compared with a control group receiving web-based OA treatment resources. Successful completion of this proposal will provide the evidence necessary to scale up this low-cost intervention, with the goal of increasing the number of adults who use exercise to manage their knee OA and thus reducing the burden of disease. The specific objectives of this project are: To examine if there is an increase in physical activity over 12 weeks among study subjects receiving Delaware PEAK, i.e., the expanded intervention, compared with a control group receiving an orientation to existing web-based resources, i.e., the brief intervention. (H1): Adults who receive the expanded intervention will have a greater increase in moderate-to-vigorous physical activity (MVPA) as measured by a research grade accelerometer (Actigraph GT3X), compared with those receiving the brief intervention over 12 weeks. To explore changes in A) health beliefs and B) self-efficacy following PEAK. (H2): Adults who receive the expanded intervention will have positive changes in health beliefs for physical activity and PT, and self-efficacy for exercise compared with those who receive the brief intervention over 12 weeks.

Official Title
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Delaware Physical Exercise and Activity for Knee Osteoarthritis (PEAK)

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Behavioral: Expanded Intervention
* Behavioral: Brief Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: meet the National Institute for Health and Care Excellence Osteoarthritis (NICE) clinical criteria: being at least 45 years of age; having activity-related joint pain; having morning stiffness ≤ 30 minutes; have a history of knee pain for at least 12 weeks; are interested in becoming more physically active; have either a cell phone or laptop/desktop computer with broadband internet connection and working email address; and are able to commit to the study for 12 weeks and willing to wear physical activity monitors live in the contiguous United States comfortable participating in a program delivered in English is able to safely participate in a moderate-intensity exercise as determined by a pre-exercise screen questionnaire. Exclusion Criteria: regularly exercise more than 60 minutes/week; or has a scheduled knee or hip joint replacement; or has had physical therapy for knee OA in the past 6 months; or participated in a strength training program for the lower extremities in the past 6 months.

Ages Eligible for Study
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Minimum Age: 45 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: Expanded Intervention<br>Virtual consultation sessions with a physical therapist, focusing on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis. | Behavioral: Expanded Intervention<br>* Participants in the Expanded Intervention arm will receive five virtual consultation sessions, delivered by a physical therapist over 12 weeks (at Weeks 1, 2, 4, 7, and 10) and lasting approximately 45-60 minutes each. Each session will focus on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis. Participants will be provided with an exercise manual, tracking log, educational manual, and a step counter. Participants will be prescribed up to 6 exercises (quadriceps, hip abductor/gluteal, hamstrings/gluteal, calf, balance) and daily walking step goals. Progression will be a joint decision by the participant and physical therapist. Education will include information on knee osteoarthritis, managing pain, being active, weight loss, dealing with setbacks, and progressing activity. The physical therapist will also discuss barriers and facilitators to meeting and progressing goals as appropriate.<br>|
| Active Comparator: Brief Intervention<br>Web-based resources on knee osteoarthritis, including an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis. | Behavioral: Brief Intervention<br>* Participants in the Brief Intervention arm will receive access to a study-specific website that navigates them to a variety of web-based resources on knee osteoarthritis. Topics for the various resources include an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis. Sessions range from 20 - 70+ minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in moderate-to-vigorous intensity physical activity | Actigraph GT3X monitor to be worn over the right hip during waking hours. Participants will be instructed to wear the monitor for 7 consecutive days, and then return the monitor via mail in a pre-addressed, pre-stamped envelope that is provided. | Baseline to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Beliefs of Physical Therapy | Participants will be asked to complete the treatment Beliefs of OA (TOA) Physical Therapy measure, which is a 9-item questionnaire that assesses health beliefs (positive and negative) related to physical therapy. | Baseline to 12 weeks | 
| Treatment Beliefs of Physical Exercise | Participants will be asked to complete the treatment Beliefs of OA (TOA) Physical Exercise measure, which is a 13-item questionnaire that assesses health beliefs (positive and negative) related to physical activity. | Baseline to 12 weeks | 
| Self Efficacy for Exercise | Participants will be asked to complete the Self-efficacy for Exercise measure, which is a 9-item questionnaire that assesses confidence (e.g., self-efficacy) in being able to exercise. | Baseline to 12 weeks | 
| Change in moderate-to-vigorous intensity physical activity | Actigraph GT3X monitor to be worn over the right hip during waking hours. Participants will be instructed to wear the monitor for 7 consecutive days, and then return the monitor via mail in a pre-addressed, pre-stamped envelope that is provided. | Baseline to 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical Activity, Physical Therapy, Telehealth, Strengthening Exercise