SuPRA: Using Wearable Activity Trackers With a New Application to Improve Physical Activity in Knee Osteoarthritis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02585323|
Recruitment Status : Unknown
Verified May 2018 by Linda Li, University of British Columbia.
Recruitment status was: Recruiting
First Posted : October 23, 2015
Last Update Posted : May 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Joint Diseases Knee Osteoarthritis||Behavioral: Education session, Fitbit/FitViz, PT counselling Behavioral: Same intervention with a 3 month delay||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Supporting Physical Activity and Reducing Sedentary Behavior in Arthritis|
|Actual Study Start Date :||April 1, 2017|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||April 2019|
Active Comparator: Immediate Intervention Group
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
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.
Placebo Comparator: Delayed Intervention Group
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
The Delayed Intervention Group will receive the same intervention as the Immediate Intervention Group, but with a 3 month delay.
- Time spent in Moderate to Vigorous Physical Activity (MVPA) [ Time Frame: Change from baseline in time spent in MVPA at 3 months, 6 months, and 9 months. ]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.
- Time spent in sedentary behaviors [ Time Frame: Change from baseline in time spent sedentary behaviors at 3 months, 6 months, and 9 months ]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.
- Knee Injury and OA Outcome Score (KOOS) [ Time Frame: Change from baseline in knee pain, stiffness, daily activity, sport/recreation, and quality of life at 3 months, 6 months, and 9 months. ]The KOOS consists of five subscales: knee pain, stiffness, daily activity, sports/recreation, and quality of life.
- Partners in Health Scale [ Time Frame: Baseline, Months 3, 6, and 9 ]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.
- Theory of Planned Behavior Questionnaire [ Time Frame: Baseline, Months 3, 6, and 9 ]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.
- The Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: Change from baseline in mood at 3 months, 6 months, and 9 months. ]The PHQ-9 consists of nine questions (rated from 0 to 3) that correspond to nine diagnostic criteria for major depressive disorder.
- The Self-Reported Habit Index (SRHI) [ Time Frame: Changes from baseline in characteristics of health behavior at 3 months, 6 months, and 9 months. ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02585323
|Contact: Navi Grewal, MScfirstname.lastname@example.org|
|Contact: Morgan Barber, MHAemail@example.com|
|Principal Investigator:||Linda Li, PhD||Associate Professor|