BackgroundPhysical activity can improve health outcomes in people with knee osteoarthritis (OA); however, participation in physical activity is very low in this population.ObjectiveThe objective of our study was to assess the feasibility and preliminary efficacy of the use of wearables (Fitbit Flex) and telephone counselling by a physical therapist (PT) for improving physical activity in people with a physician-confirmed diagnosis of knee OA, or who have passed 2 validated criteria for early OA. MethodsWe conducted a community-based feasibility randomized controlled trial. The immediate group (n=17) received a brief education session by a physical therapist, a Fitbit Flex activity tracker, and a weekly telephone call for activity counselling with the physical therapist. The delayed group (n=17) received the same intervention 1 month later. All participants were assessed at baseline (T0), and the end of 1 month (T1) and 2 months (T2). Outcomes were (1) mean moderate to vigorous physical activity time, (2) mean time spent on sedentary behavior, (3) Knee Injury and Osteoarthritis Outcome Score (KOOS), and (4) Partners in Health Scale. Feasibility data were summarized with descriptive statistics. We used analysis of covariance to evaluate the effect of the group type on the outcome measures at T1 and T2, after adjusting for blocking and T0. We assessed planned contrasts of changes in outcome measures over measurement periods.ResultsWe identified 46 eligible individuals; of those, 34 (74%) enrolled and no one dropped out. All but 1 participant adhered to the intervention protocol. We found a significant effect, with the immediate intervention group having improved in the moderate to vigorous physical activity time and in the Partners in Health Scale at T0 to T1 compared with the delayed intervention group. The planned contrast of the immediate intervention group at T0 to T1 versus the delayed group at T1 to T2 showed a significant effect in the sedentary time and the KOOS symptoms subscale, favoring the delayed group.ConclusionsThis study demonstrated the feasibility of a behavioral intervention, supported by the use of a wearable device, to promote physical activity among people with knee OA.Trial RegistrationClinicalTrials.gov NCT02313506; https://clinicaltrials.gov/ct2/show/NCT02313506 (Archived by WebCite at http://www.webcitation.org/6r4P3Bub0)

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BackgroundPhysical activity (PA) reduces pain and improves functioning in people with knee osteoarthritis (OA), but few people with the condition meet recommended PA guidelines. Successful intervention strategies to increase PA include goal setting, action planning, self-monitoring, and follow-up feedback from a healthcare professional. Recently developed consumer wearable activity trackers allow users to set activity goals, self-monitor daily goal-progress, and provide feedback on goal attainment. It is hypothesized that a multi-component physiotherapist-led intervention that includes a short (40-min) education module, guided goal-setting and action planning, the use of a wristband activity tracker, and weekly follow-up phone calls will lead to increased PA outcomes.Methods/designThirty-six participants will be recruited from the community for a two-group pilot randomized controlled trial with a stepped-wedge design using an intention-to-treat analysis. Computer-generated block randomization will be performed using varying block sizes and a 1:1 allocation ratio. The 4-week intervention will be delivered immediately (immediate-intervention group) or after a 5-week delay (delayed-intervention group). Outcome measures of pain and disability (Knee Injury and OA Outcome Score), disease self-management ability (Partners in Health Scale), and objective bouted moderate-to-vigorous PA and sedentary time (BodyMedia SenseWear Mini Armband) will be collected at baseline (week 0) and two follow-ups (weeks 5 and 10), for a total study duration of 11 weeks. Feasibility data relating to process, resource, management, and scientific elements of the trial will be collected. Outcome measure and feasibility data will be summarized, and an estimate of intervention efficacy will be obtained by regression model with planned comparisons. The trial began recruiting in February 2015. To date, 34 subjects have been recruited.DiscussionThis study will evaluate the feasibility and preliminary efficacy of a novel intervention to promote PA in people living with knee OA. The results will provide valuable information to inform a larger randomized trial to assess intervention effectiveness.Trial registrationClinicalTrials.gov Identifier: NCT02313506 (registration date 8 December 2014). First participant randomized 20 February 2015.

Background Physical activity (PA) can reduce pain and fatigue and improve quality of life in people with rheumatoid arthritis (RA), but adherence to an active lifestyle is poor. Wearable digital devices, such as Fitbit Flex™, are commercially available for people to track their PA and obtain on-demand feedback, with a goal to motivate users to be physically active. Most devices are designed for the general public. It is unclear whether it is feasible for people with RA, who have unique challenges with physical activity, to use these devices. Objectives To examine the feasibility for people with RA to use Fitbit Flex for tracking their PA and motivating them to be active. Methods Participants were recruited from rheumatologists' offices and online in Vancouver, Canada. Individuals were eligible if they were age 19 or older, had physician-diagnosed RA, were available for an orientation session, and had daily access to computer and internet service. Individuals with comorbid conditions that prevented them from being physically active were excluded. Eligible participants were given a Fitbit Flex to wear on the non-dominant wrist for 4 weeks. Instructions were provided to set up the device and their online personal profile, where they could view at real time their step count, caloric output, number of active minutes and sleep quality of the previous night. Participants also wore a SenseWear Mini™ accelerometer, a validated tool for measuring physical activity in RA patients, during the first and last 7 days of the study. Step count, energy expenditure, active time and sedentary time were compared between the two monitors using paired t-test. Participants were also asked to rate on a 5-point scale their experience with Fitbit at the end of 4 weeks. Results 10 people with RA were recruited in September 2013. The majority were women (n=8) with a median age of 57 years (IQR=17; 67). All participants adhered to the 4-week protocol. The mean rating of the overall experience with the device and the online profile was 4.7 and 4.1, respectively. Compared to Sensewear, Fitbit recorded significantly higher step counts and total sedentary time, and lower total energy expenditure and light activity time. No significant difference was found in the moderate/vigorous physical activity (MVPA) time between the two devices. Table 1 Average Daily Total: Fitbit Sensewear Difference p Mean SD Mean SD Mean SD Steps 10,710.7 4,167.0 9,131.9 4,008.5 1,578.8 1,298.5 <0.01 Energy expenditure (cal) 2,080.2 453.7 2,338.0 524.5 −257.9 269.5 0.01 Active energy expenditure (cal) 1,004.7 441.8 1,205.9 546.8 −201.2 216.6 0.02 Sedentary time (min) 1,149.2 113.2 1,062.2 126.3 87.1 40.3 <0.01 Light activity time (min) 140.0 60.1 206.4 86.1 −66.4 31.4 <0.01 *MVPA time (min) 161.2 80.6 146.9 70.2 14.3 36.8 0.25 *Fitbit: fairly + very active time vs. Sensewear: time 3+ METS. Conclusions Participants enjoyed using Fitbit Flex to monitor their physical activity. However, it appeared to overestimate the number of steps and s...