Improving Physical Activity Using an Online Monitoring Tool: a New Model of Care for Knee Osteoarthritis
Phase: NA
Conditions: Knee Osteoarthritis, Joint Diseases
Sponsor: University of British Columbia

Research Proposal 
LI, Linda C 
Improving physical activity using an online monitoring tool: a new model of care for knee osteoarthritis 
 
Version Date: February 18, 2016 
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1.0 
PROJECT OVERVIEW & RELEVANCE 
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)? We focus on knee OA because it is 
common (affecting 1 in 10) and can be debilitating.1;2 Being physically active improves pain, 
mobility and quality of life;3-5 however, less than half of patients are active.6 Combining the best 
evidence in OA care and digital technology, we 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) the use of Fitbit® FlexTM, a commercially available physical activity tracker (Figure 
1), 2) a group education session, 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 the proposed proof-of-concept randomized controlled 
trial (RCT), we hypothesize that compared to a control group, participants in the 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. 
In light of the evidence that regular physical activity promotes certain cognitive functions—
especially, memory1 and executive functions2,3—our secondary object is to examine whether 
individuals in the Intervention Group will show improved cognitive function over the 
intervention period compared to the control group. We hypothesize that individuals in the 
Intervention group will show improvements in cognition—especially in executive functions—
compared to the control group and we will explore whether these effects are strongest for those 
with the greatest uptake of MVPA. 
A tertiary object is to examine the pre-intervention factors that predict the degree to which 
individuals in the Intervention group increase MVPA and reduce sedentary time. There is 
burgeoning evidence that the brain’s response to health promotion messages predicts subsequent 
positive behaviour change,4 including the reduction of sedentary time among sedentary adults.5 
Thus, we will be using functional magnetic resonance imaging (fMRI) to examine the brain’s 
response to promotional messages to increase MVPA and decrease sedentary time among 
individuals randomized to the Intervention Group. Based on previous research,5 we will examine 
a specific region of interest—the ventromedial prefrontal cortex—and see if functional activation 
in this region predicts increases in MVPA and decreases in sedentary time over the study period. 
2.0 
BACKGROUND: Physical Activity in Osteoarthritis: Solid Evidence, Weak Uptake 
Arthritis is the most common cause of severe chronic pain and disability worldwide.7;8 There is 
evidence that physical activity can improve pain, mobility and quality of life in people with 
OA.3-5 Guidelines by the OA Research Society International recommend the use of exercise for 
knee OA.9 The Canadian Physical Activity Guidelines also recommend at least 150 minutes of 
moderate-intensity activity per week for maintaining good health, including for people with 
OA.10 Physical activity is an essential first-line treatment9 partly due to its effect in managing 
weight.11;12 Furthermore, it reduces risks of metabolic syndromes, such as the level of plasma 
glucose.13 The gap between this knowledge and the ‘action’ of being physically active, however, 
is astounding. The 2011 Canadian Community Health Survey reported that over 57% of people 
with arthritis were physically inactive during their leisure time, compared to 46% of those 
without arthritis.14 This concurs with a 2013 systematic review that only 13% of people with OA 

Research Proposal 
LI, Linda C 
Improving physical activity using an online monitoring tool: a new model of care for knee osteoarthritis 
 
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met the physical activity guidelines.15 A 2011 study using accelerometers as an objective 
measure found over 90% of people with knee OA did not meet the physical activity guidelines.16  
The current public health message is that being active is good, but OA patients may be reluctant 
to be active due to pain.17-19 For these people, maintaining some level of activity is still 
important. Recent studies indicate that sedentary lifestyle* (i.e., too much sitting) is a predictor of 
poor health outcomes.20-24 Interestingly, light activities*, even done below the moderate intensity 
level (e.g., daily tasks done while standing or walking slowly), provide health benefits.13;25;26 The 
detrimental health effect of ‘sitting too much’ is independent of the person’s activity level. 
Hence, there is a need for interventions to improve MVPA and decrease sedentary behaviours. 
2.1 
Evidence on Interventions for Improving Physical Activity 
Several modifiable risk factors are associated with low physical activity participation in people 
with arthritis. These include lack of motivation,17 doubts about the effectiveness of exercise,19 
and lack of health professional advice.27 Once patients start being active, they need feedback on 
their progress. A 2010 Cochrane review concluded that ‘graded exercise activity’, which initially 
focuses on simple exercises for weaker muscles and less painful areas before gradually 
increasing to more challenging activities, is effective for improving adherence to physical 
activity programs in chronic musculoskeletal conditions.28 Refresher sessions are recommended 
to improve performance accuracy.29 Progression of activities can be guided by a PT.28 Online 
consultation for arthritis patients has been recently studied in a RCT.30 Participants had access to 
an arthritis exercise website. The Intervention Group also received distant supervision by a PT 
via emails. The study shows a significantly greater improvement in moderate-level activity in the 
Intervention Group at six months (38% vs. 22% in the Control Group) and nine months (35% 
versus 11%).30 It did not, however, assess the effect on sedentary time reduction. Given the low 
activity participation, multi-faceted interventions that enable patients to obtain feedback from 
health professionals and receive motivational support have potential to address the gap in care.  
2.2 
Evidence on Interventions for Improving Cognition 
Engaging in regular physical activity can have the additional benefit of improving cognitive 
functioning.6 Although several previous RCTs of 6 months or longer have found that exercise 
training programs—both resistance and aerobic—improves cognition among adults who were 
initially sedentary, the degree to which a shorter, technology-based intervention promotes 
cognition is unknown. In light of the fact that a sedentary lifestyle in midlife is a risk factor for 
excessive cognitive decline with advanced age7 and the aforementioned evidence that people 
with OA tend to be sedentary, addressing this question in this population is highly relevant. 
3.0 
PROGRESS TO DATE  
In a pilot study, Feehan and Li recruited 22 healthy individuals to access the accuracy of two 
accelerometers measuring activity (ActigraphTM GT3X: the most commonly used accelerometer 
for objective physical activity measure,31;32 and SenseWearTM Mini: a newer multi-sensor 
activity monitor that has recently been used for research purposes). Although both 
accelerometers were able to accurately record MVPA, SenseWear performed notably better than 
Actigraph in differentiating between sedentary and light activities (SenseWear sensitivity = 0.98; 
specificity = 0.70; positive predictive value = 0.81).33 Based on these findings, we will use 
SenseWear as the primary outcome measure. To assess whether it is feasible for people with 
                                                 
*  Sedentary behaviour = Any waking behaviour with an energy expenditure of < 1.6 metabolic equivalent tasks (METs) 
or less while in a sitting or reclining posture. Light activity = Activities with an energy expenditure of 1.6-2.9 METS. 

Research Proposal 
LI, Linda C 
Improving physical activity using an online monitoring tool: a new model of care for knee osteoarthritis 
 
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joint pain to use physical activity trackers for an extended period of time, we recruited 10 
patients with rheumatoid arthritis (RA) to wear a Fitbit Flex for four weeks and a SenseWear 
Mini in Weeks 1 and 4. All participants complied with the protocol. The ease of use of Fitbit and 
Sensewear was rated 4.8 and 3.4 (on a 5-point scale), respectively, indicating the feasibility for 
people with joint pain to wear these devices for an extended period.34     
4.0 
METHODS (Table 1: Timeline) 
The proposed project is guided by the Action Cycle of Graham’s Knowledge-to-Action 
Process.35 We will use a mixed-methods approach, involving a proof-of-concept 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.36;37 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. Patients are eligible if they 1) have a physician confirmed diagnosis of knee OA, or are 
50 years or older and have felt pain/discomfort in or around the knee during the previous year 
that lasted more than 28 separate or consecutive days, 2) have no previous diagnosis of RA, 
psoriatic arthritis, ankylosing spondylitis, polymyalgia rheumatica, connective tissue diseases, 
fibromyalgia or gout, 3) have no history of using disease-modifying anti-rheumatic drugs or gout 
medications, 4) have no prior knee arthroplasty and not on the waiting list for total knee 
replacement surgery, 5) have not had surgery in the back, hip, knee, foot, or ankle joints in the 
past 12 months, 6) have no history of acute injury to the knee in the past 6 months, and 7) have 
an email address and daily access to a computer with internet connection. We will exclude 
people who 1) have a body mass index of greater than or equal to 40, 2) have received a steroid 
injection in  a knee in the last 6 months, 3) have received a hyaluronate injection in a knee in the 
last 6 months, 4) use medication that may impair activity tolerance (e.g., beta blockers), and 5) 
face a level of risk by exercising as identified by the Physical Activity Readiness Questionnaire 
(PAR-Q).38 In the ancillary neuroimaging study, interested participants will be further screened 
for eligibility before randomization by a trained and experienced MRI technician. 
Study Procedure (Figure 2): Participants will be recruited from the wait list of the MPAP. In 
2012-13, 250 OA patients had been referred to MPAP, approximately 50% met our eligibility 
criteria. The wait time for a PT appointment for OA is 6 months. Participants will also be 
recruited from community health centres within metropolitan areas of Delta, Surrey, Burnaby, 
New Westminster, Langley, Coquitlam, Maple Ridge, Chilliwack, Mission, and Abbotsford, 
social networking websites (Craigslist, Twitter, Kajiji, Facebook), the Arthritis Research Canada 
website, Arthritis Consumer Expert (ACE)’s JointHealth e-blast, consumer collaborators’ groups 
newsletters, websites and social media (e.g. CARP, the Arthritis Society), and VCHRI weekly e-
update which is distributed to staff, researchers, faculty, and affiliates of VCHRI. Eligible 
participants will complete the baseline measures, which includes wearing an activity monitor for 
1 week, completing an online questionnaire, and attending a cognitive assessment session at 
Vancouver General Hospital. Following completion of the baseline measures, participants will 
be randomly assigned to the Intervention Group (known as the Immediate Intervention Group) or 
Waiting List Control Group (known as the Delayed Intervention Group) in 1:1 allocation ratio. 
Randomization will be performed using computer-generated random numbers in variable block 
sizes, which are necessary to ensure adequate allocation concealment.  

Research Proposal 
LI, Linda C 
Improving physical activity using an online monitoring tool: a new model of care for knee osteoarthritis 
 
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The Immediate Intervention Group will begin the intervention right after randomization. 
Participants will be invited to attend a group session with 3-4 other participants. They will 
receive instructions to set up their Fitbit and 40 minutes of standardized education provided by a 
MPAP PT on physical activity. At the end of the session, the PT will help participants set 
activity goals and provide personalized activity options. In Months 1 and 2, participants will use 
the Fitbit Flex. Information about their physical activity will be captured by the Fitbit and 
wirelessly synchronized with the manufacturer’s online app. The app will display personalized 
activity summaries, and can be downloaded and shared with the PT. The PT will review the 
progress with participants via 20-minute biweekly phone calls and progressively modify their 
activities. Participants may also contact the PT via email if they have questions. In Months 3-6, 
participants will continue wearing the Fitbit and have access to a PT via email as needed, but no 
biweekly phone calls. The Delayed Intervention Group (Control Group) will receive the full 
intervention two months later.  Both groups will receive a monthly study newsletter during the 6-
month study period.   
Follow-up assessments will be performed at the end of Month 2, 4 and 6. To better understand 
the reasons people do or do not maintain recommended levels of physical activity, participants 
will be interviewed for one hour by phone after the intervention. Interviews will focus on 1) 
barriers/facilitators to being physically active, 2) their experience with the intervention, and 3) 
the nature of activities they engage in.  
Outcome Measures: Our primary outcome measure will be time spent in MVPA. In addition, 
we will record the time spent in sedentary behaviours. Tierney39 showed that SenseWear was a 
valid tool for estimating energy expenditure during daily activities in people with arthritis (ICC = 
0.72). It can be worn on the upper arm 24 hours a day; hence, it can capture a full picture of 
physical activity and sleep patterns.40;41 An important feature of SenseWear is its ability to 
differentiate between sedentary and light activities,33 making it an ideal instrument to assess both 
active and sedentary behaviours. We will calculate the average daily MVPA accumulated in 
bouts per day. A bout is defined as > 10 consecutive minutes at the level of > 3 METs (i.e., the 
lower bound of MVPA), with allowance for interruption of up to 2 minutes below the 
threshold.42 For sedentary behaviours, we will calculate the average daily time spent with an 
energy expenditure of < 1.6 METs, occurring in bouts of > 20 minutes during waking 
hours.24;26;43;44  
Secondary outcomes will be measured with 1) the Community Health Activities Model 
Program for Seniors (CHAMPS) 2)) the Knee Injury & OA Outcome Score (KOOS),45;46 and 3)) 
the Partners in Health Scale.47 The CHAMPS survey provides valid and reliable estimates of 
physical activity in older adults and is shown to be sensitive to change in physical activity 
intervention studies8-11. The questionnaire asks participants about their current engagement in 40 
different activities including household chores, recreational chores, and leisure and social 
activities. The KOOS consists of five subscales: knee pain, stiffness, daily activity, 
sports/recreation, and quality of life. It was originally developed for people recovering from 
anterior cruciate ligament and meniscus injury and has been validated in people with OA.45;46 
The Partners in Health Scale is a 12-item measure designed to assess self-efficacy, knowledge of 
health conditions and treatment, and self-management behaviours such as adopting a healthy 
lifestyle (Cronbach’s α=0.82).47 In addition, motivation for physical activity will be measured 
with Rhodes’s 7-point Likert-type Theory of Planned Behaviour questionnaire.48-50 It consists of 

Research Proposal 
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Improving physical activity using an online monitoring tool: a new model of care for knee osteoarthritis 
 
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16 items measuring all components of the theory. We will also track the adverse events (falls, 
cardiovascular and musculoskeletal events)51  at the follow-up assessments. 
Tertiary outcomes will be changes in cognitive functioning, led by Dr. Teresa Liu Ambrose. 
Participants will attend the 1-hour cognitive assessment session at Vancouver General Hospital 
and  complete the following computer-based assessments: 1) the Kirby task12; 2) the Stroop 
task13; 3) list-sorting task; and 4) picture sequence memory test. Each task requires 
approximately 10 minutes. The Kirby task is a delay discounting tasks and consists of 27 trials in 
which participants are asked to state their preference for a smaller, immediate monetary reward 
or a larger, delayed monetary reward. The Stroop task is a measure of response inhibition 
consists of 126 trials, equally distributed among neutral, congruent, and incongruent trial types, 
in which participants are asked to identify the color of the font for different words (both color 
and non-color words). The final two tasks are contained in the NIH Cognition Toolbox.14 The list 
sorting tasks assesses working memory by asking participants to repeat the names of orally- and 
visually-presented stimuli in order of size, from smallest to largest. The number of items per set 
increases from one trial to the next and is discontinued once 2 trials of the same length are failed. 
The picture sequence memory test assesses episodic memory by having participants remember a 
sequence of actions embedded within a story based. Specifically, participants rearrange several 
pictures on the computer screen to match the sequence of events in the story. Three trials are 
completed. In addition, participants will complete a pencil-and-paper task, consisting of the 
Montreal Cognitive Assessment (MoCA).  
Neuroimaging Procedure: Interested participants may also partake in a 1-hour neuroimaging 
session at the UBC 3T Magnetic Resonance Imaging Centre. They are eligible for MRI scanning 
if they 1) do not have cardiac pacemaker, wires, or defibrillator, 2) do not have a metal in eye or 
orbit, 3) do not have a ferromagnetic aneurysm clip, 4) do not have claustrophobia, and 5) are not 
pregnant. This session will be scheduled to occur prior to randomization. Scanning time will be 
approximately one hour. For the first 30 minutes, participants will be asked to lie at rest in the 
scanner while structural scans are obtained. The second 30 minutes will involve fMRI, during 
which participants will view a series of health promotion messages (both to increase MVPA and 
to reduce sedentary behaviour; n = 50 messages). After each message, participants will be asked 
to reflect upon those messages, including how they would apply those messages to their own 
lives. The fMRI procedure is based on a recent study of sedentary adults.5 The inclusion of a 
baseline neuroimaging procedure will allow us to address two important aims. First, we will use 
fMRI to examine the brain’s response to promotional messages to increase MVPA and decrease 
sedentary time, as well as how the brain responds differently when prompted to think about the 
long-term consequences of consuming unhealthy, yet palatable foods versus prompted to think 
about the immediate pleasurable qualities of consuming those same unhealthy, yet palatable 
foods. We will then determine whether individual differences in these neural responses predict 
future health behaviour change. We will focus on regions within the prefrontal cortex and 
striatum. Second, we will probe structural-functional connectivity associations, which will help 
us better understand how individual differences in brain function arise from differences in 
underlying brain structure. 
 
Administration of Outcomes Measures: At baseline, participants will attend the cognitive 
assessment session at Vancouver General Hospital. If a participant is interested and eligible for 
the MRI scanning, then the cognitive assessment session will take place at the UBC 3T Magnetic 
Resonance Imaging Centre. For the cognitive assessment, participants will complete the 

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computer-based tasks, MoCA (baseline only) and the CHAMPS questionnaire. Participants will 
wear the SenseWear for 7 days and complete the online questionnaire, consisting of KOOS and 
Partners in Health. At the end of Month 2, 4 and 6, participants will wear the SenseWear for 7 
days, complete the online questionnaire, and attend the cognitive assessment session again at 
Vancouver General Hospital.   
Power Calculation and Data Analysis: From MPAP and other community resources mentioned 
above, we will be able to recruit 60 participants in 10 months. For a proof-of-concept study, it is 
reasonable to expect moderately large difference between groups after the intervention. Our pilot 
study with arthritis patients found an average of 71.8 minutes (SD=96.2) of activities at 3 METs 
bouted at 10-minute intervals. Assuming an attrition rate of approximately 15%, we anticipate 50 
of the 60 participants will complete the study. With a sample size of 50 and α-level of 0.05, we 
will have 96.3% power to detect a between-group difference of at least 10 minutes after the 
intervention.  
An intention-to-treat analysis will be performed for the RCT. The main analysis will include the 
bouted mean MVPA minutes, bouted mean sedentary minutes, the KOOS, the Partners in Health 
Scale, and the cognitive assessments. For the main comparison, we will use analysis of 
covariance (ANCOVA) to compare between the Intervention Group and Control Group at 2 
months, using the baseline measure as a covariate. In addition, ANCOVA will be used to assess 
the difference between the Intervention Group at 2 months and the Control Group at 4 months, 
with the baseline measure as a covariate. We anticipate that the two groups should be similar if 
the delay of 2 months in the Control Group does not influence the effect of the intervention. We 
will also use repeated measure ANOVA to assess the within group differences over the four 
assessment periods.  
For the qualitative interviews, we will conduct an iterative content analysis, whereby codes will 
be identified and revised as interviews are analyzed. Initial open coding will be followed by 
clustering the labels into thematic categories. Quotes representative of the thematic categories 
will be identified to illustrate participants' perspectives on physical activity, nature of activities, 
and their experiences with the intervention. These data will inform the interpretation of statistical 
analyses and to refine the model of care, for example, ways for therapists to provide feedback 
about physical activity to patients or propose activities to facilitate health behaviour change.  
5.0 
LIMITATIONS  
A limitation is that the intervention requires participants to use the device continuously for two 
months. To minimize non-compliance, we choose Fitbit Flex, which can be worn on the wrist 24 
hours a day including during water-based activities. Our pilot study suggests that it is feasible for 
people with joint pain to use the device continuously for an extended period. Also, through the 
weekly phone call, the PT will ensure the device is used properly. It is possible that participants 
may gain access to a Fitbit during the non-intervention period since it is commercially available. 
To encourage adherence to the protocol, participants will be informed that the Fitbit will be 
returned to them for their continued use, free of charge, at the end of the study. 
6.0 
SIGNIFICANCE  
For patients with OA, a successful strategy to improve physical activity has far reaching 
implications, such as better mobility and quality of life. In the short term, this project will benefit 
MPAP patients with knee OA, and those in the community with knee pain or knee OA, by 
developing a new model to initiate a physically active lifestyle while they are on the 

Research Proposal 
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physiotherapy wait list. Although OA is our current focus, the proposed model can be expanded 
to serve patients with other chronic diseases in the future.  

Research Proposal 
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Improving physical activity using an online monitoring tool: a new model of care for knee osteoarthritis 
 
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Methodol 2006; 6(1):54. 

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Improving physical activity using an online monitoring tool: a new model of care for knee osteoarthritis 
 
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 (37)  Hussey MA, Hughes JP. Design and analysis of stepped wedge cluster randomized trials. 
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Improving physical activity using an online monitoring tool: a new model of care for knee osteoarthritis 
 
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 (49)  Rhodes RE, Fiala B. Building motivation and sustainability into the prescription and 
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behavior change consortium. Annals of Behavioral Medicine 2005; 29(2):20-28. 
 
 

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Improving physical activity using an online monitoring tool: a new model of care for knee osteoarthritis 
 
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Table 1:  Proof-of-concept study timeline  
 
Task 
Month 
3 
6 
9 
12 
15 
 18 
21 
24 
Obtain ethics approval (Month 1) 
 
 
 
 
 
 
 
 
 
 
 
Participant recruitment (Month 2-11) 
 
 
 
   
 
   
 
  
 
 
Data collection (Month 2-17) 
 
 
 
  
  
  
 
 
 
 
Telephone interviews (Month 4-18) 
 
  
 
 
RCT data analysis (Month 18-20) 
 
 
 
 
 
 
 
Interview & data analysis (Month 6-22) 
  
  
   
 
  
  
  
  
 
 
 
 
End-of-project KT (Month 21-24) 
 
 
 
 
 
 
 
 
 
 
 
 

Research Proposal 
LI, Linda C 
Improving physical activity using an online monitoring tool: a new model of care for knee osteoarthritis 
 
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Figure 1:  FitbitTM Flex 
 
 
 
 
Fitbit Flex is a wireless physical activity monitoring device which is designed to wear as a wrist 
band. It is a compact gross body movement tracking device that tracks and displays steps 
walked, stairs climbed and gross physical exertion. It is water resistant and can be worn during 
water-based activities. It can also be linked to several social network websites including 
Facebook and My Fitness Pal. This allows users to share experiences and successes with their 
online friends. 
 

Research Proposal 
LI, Linda C 
Improving physical activity using an online monitoring tool: a new model of care for knee osteoarthritis 
 
Version Date: February 18, 2016 
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Figure 2: 
Study procedure 
 
 
 
Participant recruitment 
Mary Pack Arthritis Program PT wait list 
Baseline evaluation 
 
SenseWear Accelerometer 
 
KOOS 
 
Theory of Planned Behaviour 
 
Partners in Health Scale 
 
Cognitive Assessment 
 
CHAMPS; MoCA (baseline only) 
 
MRI Scanning (if interested and eligible) 
Randomization 
Intervention group 
Education session, Fitbit, PT bi-
weekly calls, email access to PT 
as needed; Monthly newsletter 
Control group 
Monthly newsletter 
Fitbit, PT bi-weekly calls, email 
access to PT as needed; Monthly 
newsletter 
Education session, Fitbit, PT bi-
weekly call, email access to PT 
as needed; Monthly newsletter 
Email access to PT, as needed; 
Monthly newsletter 
Email access to PT, as needed; 
Monthly newsletter 
Fitbit, PT bi-weekly call, email 
access to PT as needed; 
Monthly newsletter 
1
st follow-up evaluation 
2
nd follow-up evaluation 
3
rd follow-up evaluation 
Month 1 
Month 2 
Month 4 
Month 3 
Months 5-6 
Email access to PT, as needed; 
Monthly newsletter 

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Improving physical activity using an online monitoring tool: a new model of care for knee osteoarthritis 
 
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