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Trial record 1 of 1 for:    nct02585323
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SuPRA: Using Wearable Activity Trackers With a New Application to Improve Physical Activity in Knee Osteoarthritis

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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
Sponsor:
Collaborators:
Simon Fraser University
Arthritis Research Centre of Canada
Fraser Health
Canadian Institutes of Health Research (CIHR)
Vancouver Coastal Health Research Institute
Information provided by (Responsible Party):
Linda Li, University of British Columbia

Brief 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. 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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


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.
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Navi Grewal, MSc 604-207-4053 ngrewal@arthritisresearch.ca
Contact: Morgan Barber, MHA 604-207-4027 mbarber@arthritisresearch.ca

Locations
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Canada, British Columbia
Arthritis Research Canada Recruiting
Richmond, British Columbia, Canada, V6X 2C7
Contact: Morgan Barber, MHA    604-207-4027    mbarber@arthritisresearch.ca   
Contact: Navi Grewal, MSc    604-207-4053    ngrewal@arthritisresearch.ca   
Sponsors and Collaborators
University of British Columbia
Simon Fraser University
Arthritis Research Centre of Canada
Fraser Health
Canadian Institutes of Health Research (CIHR)
Vancouver Coastal Health Research Institute
Investigators
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Principal Investigator: Linda Li, PhD Associate Professor
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Linda Li, Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT02585323    
Other Study ID Numbers: H15-02038
First Posted: October 23, 2015    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Linda Li, University of British Columbia:
Physical activity
Osteoarthritis
Knee
Exercise
Arthritis
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Joint Diseases
Arthritis
Musculoskeletal Diseases
Rheumatic Diseases