Clinical trial NCT02315664: MONITOR-OA: Using Wearable Activity Trackers to Improve Physical Activity in Knee Osteoarthritis
Official title: Improving Physical Activity Using an Online Monitoring Tool: a New Model of Care for Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Joint Diseases
Keywords: Physical activity
Exercise
Osteoarthritis
Knee
Arthritis
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Simon Fraser University
name: Arthritis Research Centre of Canada
name: Vancouver General Hospital
First posted: 2014-12-12
Enrollment: 61
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, a 2013 systematic review found only 13% met the activity recommendation of 150 minutes or more per week. The primary goal of this randomized controlled trail is to assess the efficacy of a physical activity counseling model, involving a group education session, the use of Fitbit Flex (a wireless physical activity tracking device), and online/telephone coaching by a physiotherapist (PT), to improve physical activity and reduce sedentary time in patients with knee OA. Engaging in regular physical activity can have the additional benefit of improving cognitive functioning.

Detailed description: This project will address the Research Question: Can a non-intrusive physical activity tracking tool, combined with a group education session and advice from a physiotherapist (PT), increase physical activity in patients with knee osteoarthritis (OA)? The investigators focus on knee OA because it is common (affecting 1 in 10) and can be debilitating. Being physically active improves pain, mobility and quality of life; however, less than half of patients are active. Combining the best evidence in OA care and digital technology, the investigators propose a new model of care for improving physical activity in patients with OA. Our primary objective is to determine whether a model involving 1) a group education session, 2) the use of Fitbit Flex, a commercially available physical activity tracker, and 3) remote coaching by a PT can improve physical activity and reduce sedentary time in patients with knee OA. This model of care is in line with the goal of Mary Pack Arthritis Program (MPAP) to optimize activity independence of OA patients with MPAP's available human resources. 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), 2) reduce sedentary time, 3) improve in OA disease status, and 4) improve in their self-efficacy of OA management, 4) To examine whether individuals in the Intervention Group will show improved cognitive function over the intervention period compared to the control group, and 5) To examine the pre-intervention factors that predict the degree to which individuals in the Intervention Group increase MVPA and reduce sedentary time.

The investigators will use a mixed-methods 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 rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, polymyalgia rheumatica, connective tissue diseases, fibromyalgia or gout.
* Have no history of using disease-modifying anti-rheumatic drugs or gout medications.
* Have no prior knee replacement surgery, 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, foot or ankle joints in the past 12 months.
* Have an email address and daily access to a computer with internet connection.
* Be able to attend a 1.5-hour education session at the Mary Pack Arthritis Centre.
* Be able to attend a 1-hour assessment session at Vancouver General Hospital prior to beginning the study, and again 2 and 4 months later.

In addition, participants may be eligible (not required) to partake in a brain magnetic resonance imaging (MRI) assessment if they:

* Do not have a pacemaker, brain aneurysm clip, cochlear implant, electrical stimulator for nerves or bones, implanted infusion pump, artificial heart valve, orthopaedic hardware, other metallic prostheses, coil, catheter or filter in any blood vessel, ear or eye implant, bullets or other metallic fragments.
* Do not have a history of any eye injury involving metal fragments.
* Do not have a history of claustrophobia (i.e. fearful of being in closed or narrow spaces).
* Have not had surgery or tattoos within the past 6 weeks.
* Are able to attend a 1-hour session at the UBC 3T Magnetic Resonance Imaging Centre (2221 Wesbrook Mall, Vancouver).

Exclusion Criteria:

* Have a body mass index of equal to or greater than 40
* Have received a steroid injection in a knee in the last 6 months
* Have received a hyaluronate injection in a knee in the last 6 months
* Use medication that may impair activity tolerance (e.g. beta blockers)
* Are at risk when exercising, as identified by the Physical Activity Readiness Questionnaire (PAR-Q)

Primary outcomes:
measure: Time Spent in Moderate-to-Vigorous Physical Activity (MVPA)
timeFrame: Baseline; 2 months, 4 months and 6 months from baseline
Secondary outcomes:
measure: Time Spent in Sedentary Behaviors
timeFrame: Change from baseline in time spent sedentary behaviors at 2 months, 4 months, and 6 months.
measure: KOOS - Symptoms
timeFrame: Baseline; 2 months, 4 months and 6 months from baseline
measure: KOOS - Pain
timeFrame: Baseline; 2 months, 4 months and 6 months from baseline
measure: KOOS - Activity of Daily Living
timeFrame: Baseline; 2 months, 4 months and 6 months from baseline
measure: KOOS - Sports & Recreation
timeFrame: Baseline; 2 months, 4 months and 6 months from baseline
measure: KOOS - Quality of Life
timeFrame: Baseline; 2 months, 4 months and 6 months from baseline
measure: Partners in Health Scale
timeFrame: Baseline; 2 months, 4 months and 6 months from baseline
Other outcomes:
Locations:
city: Richmond
country: Canada
facility: Arthritis Research Canada
state: British Columbia
Study officials:
affiliation: Arthritis Research Canada
name: Linda Li, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Falck RS, Best JR, Li LC, Chan PCY, Feehan LM, Liu-Ambrose T. Can we improve cognitive function among adults with osteoarthritis by increasing moderate-to-vigorous physical activity and reducing sedentary behaviour? Secondary analysis of the MONITOR-OA study. BMC Musculoskelet Disord. 2018 Dec 21;19(1):447. doi: 10.1186/s12891-018-2369-z.
citation: Li LC, Sayre EC, Xie H, Falck RS, Best JR, Liu-Ambrose T, Grewal N, Hoens AM, Noonan G, Feehan LM. Efficacy of a Community-Based Technology-Enabled Physical Activity Counseling Program for People With Knee Osteoarthritis: Proof-of-Concept Study. J Med Internet Res. 2018 Apr 30;20(4):e159. doi: 10.2196/jmir.8514.