- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02585323
SuPRA: Using Wearable Activity Trackers With a New Application to Improve Physical Activity in Knee Osteoarthritis
Supporting Physical Activity and Reducing Sedentary Behavior in Arthritis
Study Overview
Status
Conditions
Detailed Description
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Navi Grewal, MSc
- Phone Number: 604-207-4053
- Email: ngrewal@arthritisresearch.ca
Study Contact Backup
- Name: Morgan Barber, MHA
- Phone Number: 604-207-4027
- Email: mbarber@arthritisresearch.ca
Study Locations
-
-
British Columbia
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Richmond, British Columbia, Canada, V6X 2C7
- Recruiting
- Arthritis Research Canada
-
Contact:
- Navi Grewal, MSc
- Phone Number: 604-207-4053
- Email: ngrewal@arthritisresearch.ca
-
Contact:
- Morgan Barber, MHA
- Phone Number: 604-207-4027
- Email: mbarber@arthritisresearch.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
|
The Delayed Intervention Group will receive the same intervention as the Immediate Intervention Group, but with a 3 month delay.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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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.
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Change from baseline in time spent in MVPA at 3 months, 6 months, and 9 months.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Change from baseline in time spent sedentary behaviors at 3 months, 6 months, and 9 months
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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.
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The KOOS consists of five subscales: knee pain, stiffness, daily activity, sports/recreation, and quality of life.
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Change from baseline in knee pain, stiffness, daily activity, sport/recreation, and quality of life at 3 months, 6 months, and 9 months.
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Partners in Health Scale
Time Frame: Baseline, Months 3, 6, and 9
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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.
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Baseline, Months 3, 6, and 9
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Theory of Planned Behavior Questionnaire
Time Frame: Baseline, Months 3, 6, and 9
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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.
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Baseline, Months 3, 6, and 9
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The Patient Health Questionnaire-9 (PHQ-9)
Time Frame: Change from baseline in mood at 3 months, 6 months, and 9 months.
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The PHQ-9 consists of nine questions (rated from 0 to 3) that correspond to nine diagnostic criteria for major depressive disorder.
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Change from baseline in mood at 3 months, 6 months, and 9 months.
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The Self-Reported Habit Index (SRHI)
Time Frame: Changes from baseline in characteristics of health behavior at 3 months, 6 months, and 9 months.
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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.
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Changes from baseline in characteristics of health behavior at 3 months, 6 months, and 9 months.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Linda Li, PhD, Associate Professor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H15-02038
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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