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Completed

NCT Number: NCT02585323

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

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arthritis Research Canada, Vancouver, British Columbia, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Education session, Fitbit/FitViz, PT counselling

Behavioral

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 delay

Behavioral

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

Primary outcomes

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

    Time frame: Baseline, 13 weeks, 26 weeks, 39 weeks

    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.

Secondary outcomes

  1. Daily Number of Sedentary Minutes

    Time frame: Baseline, 13 weeks, 26 weeks, 39 weeks

    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.

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

    Time frame: Baseline, 13 weeks, 26 weeks, 39 weeks

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

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

    Time frame: Baseline, 13 weeks, 26 weeks, 39 weeks

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

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

    Time frame: Baseline, 13 weeks, 26 weeks, 39 weeks

    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.

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

    Time frame: Baseline, 13 weeks, 26 weeks, 39 weeks

    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.

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

    Time frame: Baseline, 13 weeks, 26 weeks, 39 weeks

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

  7. The Patient Health Questionnaire-9 (PHQ-9)

    Time frame: Baseline, 13 weeks, 26 weeks, 39 weeks

    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),

  8. Partners in Health Scale

    Time frame: Baseline, Months 3, 6, and 9

    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.

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

    Time frame: Baseline, 13 weeks, 26 weeks, 39 weeks

    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.

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

    Time frame: Baseline, 13 weeks, 26 weeks, 39 weeks

    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.

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

    Time frame: Baseline, 13 weeks, 26 weeks, 39 weeks

    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.

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

    Time frame: Baseline, 13 weeks, 26 weeks, 39 weeks

    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)

  13. Theory of Planned Behavior Questionnaire - Subjective Norm

    Time frame: Baseline, 13 weeks, 26 weeks, 39 weeks

    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)

  14. Theory of Planned Behavior Questionnaire - Perceived Control

    Time frame: Baseline, 13 weeks, 26 weeks, 39 weeks

    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)

  15. Theory of Planned Behavior Questionnaire - Intention

    Time frame: Baseline, 13 weeks, 26 weeks, 39 weeks

    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)

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Arthritis Research Centre of Canada
  • Canadian Institutes of Health Research (CIHR)
  • Fraser Health
  • Simon Fraser University
  • Vancouver Coastal Health Research Institute

Registry information

Official study title

Supporting Physical Activity and Reducing Sedentary Behavior in Arthritis

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 23, 2015
Registry last updated
Oct 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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