Clinical trial NCT02585323: SuPRA: Using Wearable Activity Trackers With a New Application to Improve Physical Activity in Knee Osteoarthritis
Official title: Supporting Physical Activity and Reducing Sedentary Behavior in Arthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Joint Diseases
Knee Osteoarthritis
Keywords: Physical activity
Osteoarthritis
Knee
Exercise
Arthritis
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Simon Fraser University
name: Arthritis Research Centre of Canada
name: Fraser Health
name: Canadian Institutes of Health Research (CIHR)
name: Vancouver Coastal Health Research Institute
First posted: 2015-10-23
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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.

Primary outcomes:
measure: Time spent in Moderate to Vigorous Physical Activity (MVPA)
timeFrame: Change from baseline in time spent in MVPA at 3 months, 6 months, and 9 months.
Secondary outcomes:
measure: Time spent in sedentary behaviors
timeFrame: Change from baseline in time spent sedentary behaviors at 3 months, 6 months, and 9 months
measure: Knee Injury and OA Outcome Score (KOOS)
timeFrame: Change from baseline in knee pain, stiffness, daily activity, sport/recreation, and quality of life at 3 months, 6 months, and 9 months.
measure: Partners in Health Scale
timeFrame: Baseline, Months 3, 6, and 9
measure: Theory of Planned Behavior Questionnaire
timeFrame: Baseline, Months 3, 6, and 9
measure: The Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Change from baseline in mood at 3 months, 6 months, and 9 months.
measure: The Self-Reported Habit Index (SRHI)
timeFrame: Changes from baseline in characteristics of health behavior at 3 months, 6 months, and 9 months.
Other outcomes:
Locations:
city: Richmond
country: Canada
facility: Arthritis Research Canada
state: British Columbia
Study officials:
affiliation: Associate Professor
name: Linda Li, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.