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Joint DiseasesNCT02585323

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

A study testing Education session, Fitbit/FitViz, PT counselling and Same intervention with a 3 month delay in people with Joint Diseases and Knee Osteoarthritis, run by University of British Columbia at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Joint Diseases, Knee Osteoarthritis
What is being tested?
Education session, Fitbit/FitViz, PT counselling and Same intervention with a 3 month delay
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
51 participants
Where
2 sitesCanada
Study dates
1 Apr 2017to 26 Aug 2019
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Canada2 sites
  • Arthritis Research Canada

    Vancouver, British Columbia, V5Y 3P2

  • Arthritis Research Canada

    Vancouver, British Columbia, V6X 2C7

Other trials in Canada

About this study

Official title: Supporting Physical Activity and Reducing Sedentary Behavior in Arthritis

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.

Read the 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.

Being tested
Education session, Fitbit/FitViz, PT counselling, Same intervention with a 3 month delay
Keywords
Physical activity, Osteoarthritis, Knee, Exercise, Arthritis
Medical subject headings
Joint Diseases, Osteoarthritis, Knee, Motor Activity, Osteoarthritis, Arthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Education session, Fitbit/FitViz, PT counsellingBehavioural

    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.

  • Same intervention with a 3 month delayBehavioural

    The Delayed Intervention Group will receive the same intervention as the Immediate Intervention Group, but with a 3 month delay.

Study groups in NCT02585323
Study groupRoleWhat they receive
Immediate Intervention GroupActive comparatorEducation 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.
Receives: Behavioral: Education session, Fitbit/FitViz, PT counselling
Delayed Intervention GroupPlacebo comparatorSame 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.
Receives: Behavioral: Same intervention with a 3 month delay

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Daily Number of Minutes in Moderate/Vigorous Physical Activity

    Time spent in Moderate/Vigorous Physical Activity (MVPA) was measured with a SenseWear Mini sensor over a 7-day period. The mean time was calculated in bouted MVPA per day. A bout is defined as >= 10 consecutive minutes or more at the level of >= 3 METs (i.e., the lower bound of MVPA), with allowance for interruption of up to two minutes below the threshold.

    Measured: Baseline, 13 weeks, 26 weeks, 39 weeks

Secondary outcomes (15)
  1. Daily Number of Sedentary Minutes

    Time spent in sedentary behaviour was measured with a SenseWear Mini sensor over a 7-day period. The mean daily time spent in sedentary activity was calculated with an energy expenditure of <=1.5 METs, occurring in bouts of >= 20 minutes during waking hours.

    Measured: Baseline, 13 weeks, 26 weeks, 39 weeks

  2. Knee Injury and Osteoarthritis Outcome Score (KOOS) - Symptom

    The Symptom Subscale ranges from 0 - 100, with 0 indicates extreme knee symptoms and 100 indicates no knee symptoms.

    Measured: Baseline, 13 weeks, 26 weeks, 39 weeks

  3. Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain

    The Pain Subscale ranges from 0 - 100, with 0 indicates extreme knee pain and 100 indicates no knee pain.

    Measured: Baseline, 13 weeks, 26 weeks, 39 weeks

  4. Knee Injury and Osteoarthritis Outcome Score (KOOS) - Sport and Recreation

    The Sport and Recreation Subscale ranges from 0 - 100, with 0 indicates extreme difficulties with sport and recreational activities due to knee problems and 100 indicates no difficulties.

    Measured: Baseline, 13 weeks, 26 weeks, 39 weeks

  5. Knee Injury and Osteoarthritis Outcome Score (KOOS) - Activity of Daily Living

    The Activity of Daily Living Subscale ranges from 0 - 100, with 0 indicates extreme difficulties with activity of daily living and 100 indicates no difficulties.

    Measured: Baseline, 13 weeks, 26 weeks, 39 weeks

  6. Knee Injury and Osteoarthritis Outcome Score (KOOS) - Quality of Life

    The Quality of Life Subscale ranges from 0 - 100, with 0 indicates extreme problems with the knee and 100 indicates no problems.

    Measured: Baseline, 13 weeks, 26 weeks, 39 weeks

  7. 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. Range 0-27; lower score = less depressive symptoms),

    Measured: Baseline, 13 weeks, 26 weeks, 39 weeks

  8. Partners in Health Scale

    The Partners in Health Scale ranges from 0 to 96, calculated from responses to 12 items on a 9-point Likert scale. A score of 0 represents poor self-management, and a score of 96 represents greater self-management capabilities.

    Measured: Baseline, Months 3, 6, and 9

  9. Self-Reported Habit Index (SRHI) - Sitting at Work Subscale

    The SRHI is a 12-item scale, rated on a 7-point Likert scale, that measures characteristics of habitual behavior. In the Habit index, participants rated 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 10 minutes. A higher score indicates a stronger habit or behavior that is done frequently, automatically, and done without thinking about it. Range 1-7; higher score = stronger habit.

    Measured: Baseline, 13 weeks, 26 weeks, 39 weeks

  10. Self-Reported Habit Index (SRHI) - Sitting at Leisure Subscale

    The SRHI is a 12-item scale, rated on a 7-point Likert scale, that measures characteristics of habitual behavior. In the Habit index, participants rated 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 10 minutes. A higher score indicates a stronger habit or behavior that is done frequently, automatically, and done without thinking about it. Range 1-7; higher score = stronger habit.

    Measured: Baseline, 13 weeks, 26 weeks, 39 weeks

  11. Self-Reported Habit Index (SRHI) - Walking Subscale

    The SRHI is a 12-item scale, rated on a 7-point Likert scale, that measures characteristics of habitual behavior. In the Habit index, participants rated 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 10 minutes. A higher score indicates a stronger habit or behavior that is done frequently, automatically, and done without thinking about it. Range 1-7; higher score = stronger habit.

    Measured: Baseline, 13 weeks, 26 weeks, 39 weeks

  12. Theory of Planned Behavior Questionnaire - Attitude Toward Physical Activity

    The Theory of Planned Behavior Questionnaire consists of 16 items measuring all components of theory. It was used to measure motivation for physical activity. Range: 1-7; higher = more positive)

    Measured: Baseline, 13 weeks, 26 weeks, 39 weeks

  13. Theory of Planned Behavior Questionnaire - Subjective Norm

    The Theory of Planned Behavior Questionnaire consists of 16 items measuring all components of theory. It was used to measure motivation for physical activity. Range: 1-7; higher = more positive)

    Measured: Baseline, 13 weeks, 26 weeks, 39 weeks

  14. Theory of Planned Behavior Questionnaire - Perceived Control

    The Theory of Planned Behavior Questionnaire consists of 16 items measuring all components of theory. It was used to measure motivation for physical activity. Range: 1-7; higher = more positive)

    Measured: Baseline, 13 weeks, 26 weeks, 39 weeks

  15. Theory of Planned Behavior Questionnaire - Intention

    The Theory of Planned Behavior Questionnaire consists of 16 items measuring all components of theory. It was used to measure motivation for physical activity. Range: 1-7; higher = more positive)

    Measured: Baseline, 13 weeks, 26 weeks, 39 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2015 (estimated)
  2. Study start1 Apr 2017
  3. Primary completion21 Aug 2019
  4. Study completion26 Aug 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02585323
Sponsor's protocol ID
H15-02038
Status last verified
Sep 2025
First submitted
21 Oct 2015
Last updated
6 Oct 2025
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Li LC, Feehan LM, Xie H, Lu N, Shaw CD, Gromala D, Zhu S, Avina-Zubieta JA, Hoens AM, Koehn C, Tam J, Therrien S, Townsend AF, Noonan G, Backman CL. Effects of a 12-Week Multifaceted Wearable-Based Program for People With Knee Osteoarthritis: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Jul 3;8(7):e19116. doi: 10.2196/19116.

    PubMed 32618578

Questions about this trial

What is this clinical trial studying?

A study testing Education session, Fitbit/FitViz, PT counselling and Same intervention with a 3 month delay in people with Joint Diseases and Knee Osteoarthritis, run by University of British Columbia at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Daily Number of Minutes in Moderate/Vigorous Physical Activity (time frame: Baseline, 13 weeks, 26 weeks, 39 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02585323, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025.

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