SuPRA: Using Wearable Activity Trackers With a New Application to Improve Physical Activity in Knee Osteoarthritis

Study Overview
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Brief Summary
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Physical activity is an essential first-line treatment for patients with knee osteoarthritis (OA). However, only 13% of patients meet the activity recommendation of 150 minutes or more per week. The primary goal of this randomized controlled trial is to assess the efficacy of a Fitbit Flex (a wireless physical activity tracking device) paired with a new application, plus a brief education session and telephone counselling by a physiotherapist (PT), to improve physical activity and reduce sedentary time in patients with knee osteoarthritis.

Detailed Description
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Current practice guidelines emphasize the use of exercise and weight reduction as the first-line management of knee osteoarthritis (OA; affecting 1 in 10 Canadians). However, up to 90% of people with OA are inactive. Several modifiable risk factors are associated with low physical activity participation, including lack of motivation, doubts about the effectiveness of prescribed exercises and lack of health professional advice regarding ways to progress their physical activity. The variety of risk factors highlights the need for a multifaceted approach that provides support in terms of knowledge, skill development and timely advice from health professionals, as well as motivational support to stay active. Our primary objective is to assess the efficacy of a Fitbit/Fitviz intervention, involving the use of a Fitbit Flex paired with a FitViz application (app), a brief education session, and telephone counselling by a physiotherapist, to improve physical activity participation and reduce sedentary time in people with knee OA. Our secondary objective is to assess the effect of the intervention on patients' OA disease status and self-efficacy in disease management. We will carry out three aims: 1) To develop the FitViz app to pair with Fitbit to enhance user experience; 2) To conduct a pilot test for the Fitbit/FitViz intervention; 3) To evaluate the effect of the Fitbit/FitViz intervention in patients with knee OA. In this proof-of-concept randomized controlled trial (RCT), the investigators hypothesize that compared to a control group (i.e. the Delayed Intervention Group), participants in the Immediate Intervention Group will 1) increase moderate/vigorous physical activity (MVPA) as determined by an objective measure, 2) reduce sedentary time during waking hours, 3) improve in OA disease status, and 4) improve in their self-efficacy of OA management. The investigators will use a mixed-method approach, involving a RCT and in-depth interviews. The proof-of-concept study will employ a stepped wedge RCT design, whereby the intervention will be sequentially rolled out to participants over a number of time periods. The order in which individuals receive the intervention will be determined at random. The strength of this design is that it can properly address the efficacy question, while avoiding the dilemma of withholding the intervention to some participants, as in a parallel group design.

Official Title
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Supporting Physical Activity and Reducing Sedentary Behavior in Arthritis

Conditions
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Joint Diseases, Knee Osteoarthritis

Intervention / Treatment
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* Behavioral: Education session, Fitbit/FitViz, PT counselling
* Behavioral: Same intervention with a 3 month delay


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a physician confirmed diagnosis of knee osteoarthritis OR are both 1) over 50, and 2) have experienced 4 weeks of pain, aching, or discomfort in or around the knee during the last year (equal to or more than 28 separate or consecutive days). Have no previous diagnosis of inflammatory arthritis (e.g., rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis), connective tissue diseases, or gout. Have no history of using disease-modifying anti-rheumatic drugs, such as hydroxychloroquine, sulfasalazine, methotrexate, biologic agents (e.g., Humira, Enbrel), or gout medications. Have no prior knee arthroplasty, and not on a waiting list for total knee replacement surgery. Have no history of acute injury to the knee in the past 6 months. Have not had surgery in the back, hip, knee, or ankle joints in the past 12 months. Have an email address and use online/mobile applications. Are able to attend one 1.5-hour education session. Exclusion Criteria: Have received a hyaluronate injection in a knee in the last 6 months. Have received a steroid injection in a knee in the last 6 months. Are at risk when exercising, as identified by the Physical Activity Readiness Questionnaire.

Ages Eligible for Study
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Minimum Age: 19 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: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Immediate Intervention Group<br>Education session, Fitbit/FitViz, PT counselling: Participants receive this intervention in Months 1-3. The session will include a presentation on physical activity, an individual goal-setting session with a registered physiotherapist, and an orientation to the Fitbit Flex and the FitViz app. In Months 1 and 2, participants will use the Fitbit/FitViz. The PT will review the progress with participants via 20-minute bi-weekly phone calls, and progressively modify their activities. In Month 3, participants will continue using the Fitbit/FitViz and have access to a PT via email as needed, but no bi-weekly phone calls. In Months 4-9, participants may continue using the Fitbit/FitViz without access to a PT. | Behavioral: Education session, Fitbit/FitViz, PT counselling<br>* Participants will receive a brief education session, use a physical activity tracker Fitbit Flex with paired with a FitViz app, and remote counseling by a PT. Intervention will be received immediately.<br>|
| Placebo Comparator: Delayed Intervention Group<br>Same intervention with a 3 month delay: The full intervention will be initiated in Month 4 and with a brief education session, use of a Fitbit Flex paired with the FitViz app, and counseling by a physiotherapist. In Months 6-9, participants will continue using Fitbit/FitViz without the PT phone calls. | Behavioral: Same intervention with a 3 month delay<br>* The Delayed Intervention Group will receive the same intervention as the Immediate Intervention Group, but with a 3 month delay.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time spent in Moderate to Vigorous Physical Activity (MVPA) | Participants will wear a SenseWear Mini accelerometer for 7 days at baseline, and at the end of Months 3, 6, and 9. We will calculate the average daily MVPA accumulated in bouts per day. A bout is defined as greater than or equal to 10 consecutive minutes at the level of 3 or higher METs, with allowance for interruption of up to 2 minutes below the threshold. | Change from baseline in time spent in MVPA at 3 months, 6 months, and 9 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time spent in sedentary behaviors | We will calculate the average daily time spent with an energy expenditure of 1.5 METs or lower, occurring in bouts of > 20 minutes during waking hours. | Change from baseline in time spent sedentary behaviors at 3 months, 6 months, and 9 months | 
| Knee Injury and OA Outcome Score (KOOS) | The KOOS consists of five subscales: knee pain, stiffness, daily activity, sports/recreation, and quality of life. | Change from baseline in knee pain, stiffness, daily activity, sport/recreation, and quality of life at 3 months, 6 months, and 9 months. | 
| Partners in Health Scale | The Partners in Health Scale is a 12-item measure designed to assess self-efficacy, knowledge of health conditions and treatment, and self-management behaviors such as adopting a healthy lifestyle. | Baseline, Months 3, 6, and 9 | 
| Theory of Planned Behavior Questionnaire | The Theory of Planned Behavior Questionnaire consists of 16 items measuring all components of theory. It will be used to measure motivation for physical activity. | Baseline, Months 3, 6, and 9 | 
| The Patient Health Questionnaire-9 (PHQ-9) | The PHQ-9 consists of nine questions (rated from 0 to 3) that correspond to nine diagnostic criteria for major depressive disorder. | Change from baseline in mood at 3 months, 6 months, and 9 months. | 
| The Self-Reported Habit Index (SRHI) | The SRHI is as 12-item scale, rated on a 7-point Likert scale, that measures characteristics of habitual behavior. We will ask participants to rate their strength of habit for three specific activity-related behaviors: sitting during leisure time at home, sitting during usual occupational activities, and walking outside for more than 10 minutes. A higher score indicates a stronger habit or behavior that is done frequently, automatically, and done without thinking about it. | Changes from baseline in characteristics of health behavior at 3 months, 6 months, and 9 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical activity, Osteoarthritis, Knee, Exercise, Arthritis