MONITOR-OA: Using Wearable Activity Trackers to Improve Physical Activity in Knee Osteoarthritis

Improving Physical Activity Using an Online Monitoring Tool: a New Model of Care for Knee Osteoarthritis

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02315664

Enrollment

Registered

2014-12-12

Start date

2015-11-02

Completion date

2017-05-25

Last updated

2019-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Joint Diseases, Knee Osteoarthritis

Keywords

Physical activity, Exercise, Osteoarthritis, Knee, Arthritis

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.

Interventions

BEHAVIORALEducation session, Fitbit Flex, and remote coaching by a PT

Participants will receive a brief education session, use of a commercially available physical activity tracker called Fitbit Flex, and remote counseling by a PT. Intervention will be received immediately.

BEHAVIORALSame intervention with a 2 month delay

The Delayed Intervention Group will receive the same intervention as the Immediate Intervention Group, but with a 2 month delay.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Time Spent in Moderate-to-Vigorous Physical Activity (MVPA)	Baseline; 2 months, 4 months and 6 months from baseline	Participants wore a SenseWear Mini accelerometer for 7 days at baseline, and Months 2, 4, and 6. We calculated the average daily time (minutes) spent in MVPA accumulated in bouts. A bout is defined as 10 or more consecutive minutes at the level of 3 or higher METs, with allowance for interruption of up to 1 minute below the threshold.

Secondary

Measure	Time frame	Description
KOOS - Symptoms	Baseline; 2 months, 4 months and 6 months from baseline	Symptoms were measured by Knee Injury and OA Outcome Score (KOOS). The KOOS measures knee osteoarthritis disease status and consists of five sub-scales: knee pain, stiffness, daily activity, sports/recreation, and quality of life. Scores range from 0 to 100, with higher being better.
KOOS - Pain	Baseline; 2 months, 4 months and 6 months from baseline	Pain was measured by Knee Injury and OA Outcome Score (KOOS). The KOOS measures knee osteoarthritis disease status and consists of five sub-scales: knee pain, stiffness, daily activity, sports/recreation, and quality of life. Scores range from 0 to 100, with higher being better.
KOOS - Activity of Daily Living	Baseline; 2 months, 4 months and 6 months from baseline	Activity of Daily Living was measured by Knee Injury and OA Outcome Score (KOOS). The KOOS measures knee osteoarthritis disease status and consists of five sub-scales: knee pain, stiffness, daily activity, sports/recreation, and quality of life. Scores range from 0 to 100, with higher being better.
Time Spent in Sedentary Behaviors	Change from baseline in time spent sedentary behaviors at 2 months, 4 months, and 6 months.	We calculated the average daily time spent with an energy expenditure of 1.5 METs or lower, occurring in bouts of 20 minutes or more during waking hours.
KOOS - Quality of Life	Baseline; 2 months, 4 months and 6 months from baseline	Quality of Life was measured by Knee Injury and OA Outcome Score (KOOS). The KOOS measures knee osteoarthritis disease status and consists of five sub-scales: knee pain, stiffness, daily activity, sports/recreation, and quality of life. Scores range from 0 to 100, with higher being better.
Partners in Health Scale	Baseline; 2 months, 4 months and 6 months from baseline	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. Scores range from 0 to 96, with lower being better.
KOOS - Sports & Recreation	Baseline; 2 months, 4 months and 6 months from baseline	Sports & Recreation was measured by Knee Injury and OA Outcome Score (KOOS). The KOOS measures knee osteoarthritis disease status and consists of five sub-scales: knee pain, stiffness, daily activity, sports/recreation, and quality of life. Scores range from 0 to 100, with higher being better.

Countries

Canada

Participant flow

Recruitment details

The recruitment period was from February 2015 - October 2016. Recruitment strategies included placing study advertisement material at Community Health Centres and Mary Pack Arthritis Centre. We also had study advertisement disseminated through Arthritis Research Canada website and group collaborators' group newsletters.

Pre-assignment details

After enrollment, participants completed the baseline assessment, and after completion of baseline participants were randomly assigned to the immediate group or the delayed group (ie, control) in 1:1 allocation ratio.

Participants by arm

Arm	Count
Immediate Intervention Group Education session, Fitbit Flex, and remote coaching by a PT: These three components of the intervention will be delivered to the participants in Month 1 and 2. At the end of the education session, the PT will help participants set personal activity goals. In Month 1 and 2, participants will use the Fitbit Flex. The PT will review the progress with participants via 20-minute bi-weekly phone calls and progressively modify their activities. In Month 3-6, participants will keep the Fitbit and continue to use it with access to a PT via email as needed. In addition, they will receive a monthly e-newsletter about arthritis research that is not related to physical activity.	30
Delayed Intervention Group Same intervention with a 2 month delay: The Delayed Intervention Group (control group) will receive the same monthly e-newsletter in Months 1-2. The full intervention will be initiated in Month 3 with a brief education session, use of Fitbit Flex, and counseling by a physiotherapist. In Month 4, they will continue the intervention without the PT phone calls. Participants will keep the Fitbit for Month 5-6, and have email access to PT as needed.	31
Total	61

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	1	1
Overall Study	Withdrawal by Subject	0	3

Baseline characteristics

Characteristic	Total	Immediate Intervention Group	Delayed Intervention Group
Age, Continuous	61.7 years STANDARD_DEVIATION 8.9	61.3 years STANDARD_DEVIATION 9.4	62.1 years STANDARD_DEVIATION 8.5
Body mass index	29.2 kg/m^2 STANDARD_DEVIATION 5.1	29.2 kg/m^2 STANDARD_DEVIATION 5.5	29.2 kg/m^2 STANDARD_DEVIATION 4.8
Compared to one year ago, how would you rate your health in general now? About the same	27 Participants	12 Participants	15 Participants
Compared to one year ago, how would you rate your health in general now? Much better	4 Participants	2 Participants	2 Participants
Compared to one year ago, how would you rate your health in general now? Much worse	0 Participants	0 Participants	0 Participants
Compared to one year ago, how would you rate your health in general now? Somewhat better	9 Participants	6 Participants	3 Participants
Compared to one year ago, how would you rate your health in general now? Somewhat worse	21 Participants	10 Participants	11 Participants
Diagnosed with OA No, but met the likely OA criteria	9 Participants	4 Participants	5 Participants
Diagnosed with OA Yes	52 Participants	26 Participants	26 Participants
Gross annual household income (CAN$) >100,000	11 Participants	5 Participants	6 Participants
Gross annual household income (CAN$) ≤12,000	0 Participants	0 Participants	0 Participants
Gross annual household income (CAN$) 12,001-24,000	3 Participants	1 Participants	2 Participants
Gross annual household income (CAN$) 24,001-40,000	6 Participants	4 Participants	2 Participants
Gross annual household income (CAN$) 40,001-60,000	11 Participants	5 Participants	6 Participants
Gross annual household income (CAN$) 60,001-80,000	13 Participants	9 Participants	4 Participants
Gross annual household income (CAN$) 80,001-100,000	5 Participants	2 Participants	3 Participants
Gross annual household income (CAN$) No answer	12 Participants	4 Participants	8 Participants
In general would you say your health is... Excellent	1 Participants	1 Participants	0 Participants
In general would you say your health is... Fair	7 Participants	4 Participants	3 Participants
In general would you say your health is... Good	24 Participants	10 Participants	14 Participants
In general would you say your health is... Poor	0 Participants	0 Participants	0 Participants
In general would you say your health is... Very good	29 Participants	15 Participants	14 Participants
Marital Status Married/Common Law	33 Participants	19 Participants	14 Participants
Marital Status Separated/Divorced	15 Participants	7 Participants	8 Participants
Marital Status Widowed/Never married/Other	13 Participants	4 Participants	9 Participants
Number of comorbid conditions	3.0 Comorbid conditions	2.0 Comorbid conditions	4.0 Comorbid conditions
Race and Ethnicity Not Collected	0 Participants	—	—
Region of Enrollment Canada	61 participants	30 participants	31 participants
Sex: Female, Male Female	50 Participants	22 Participants	28 Participants
Sex: Female, Male Male	11 Participants	8 Participants	3 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 30	0 / 31
other Total, other adverse events	0 / 30	0 / 31
serious Total, serious adverse events	0 / 30	0 / 31

Outcome results

Primary

Time Spent in Moderate-to-Vigorous Physical Activity (MVPA)

Participants wore a SenseWear Mini accelerometer for 7 days at baseline, and Months 2, 4, and 6. We calculated the average daily time (minutes) spent in MVPA accumulated in bouts. A bout is defined as 10 or more consecutive minutes at the level of 3 or higher METs, with allowance for interruption of up to 1 minute below the threshold.

Time frame: Baseline; 2 months, 4 months and 6 months from baseline