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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02315664
• Other study ID #: H14-01762
• Status: Completed
• Phase: N/A
• Start date: November 2, 2015
• Est. completion date: May 25, 2017

Study information

• Verified date: September 2019
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: May 25, 2017
• Est. primary completion date: May 17, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Joint Diseases
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Behavioral:
• Education 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.
• Same 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.

Locations

Country	Name	City	State
Canada	Arthritis Research Canada	Richmond	British Columbia

Sponsors (4)

Lead Sponsor	Collaborator
University of British Columbia	Arthritis Research Centre of Canada, Simon Fraser University, Vancouver General Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline; 2 months, 4 months and 6 months from baseline
Secondary	Time Spent in Sedentary Behaviors	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.	Change from baseline in time spent sedentary behaviors at 2 months, 4 months, and 6 months.
Secondary	KOOS - Symptoms	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.	Baseline; 2 months, 4 months and 6 months from baseline
Secondary	KOOS - Pain	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.	Baseline; 2 months, 4 months and 6 months from baseline
Secondary	KOOS - Activity of Daily Living	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.	Baseline; 2 months, 4 months and 6 months from baseline
Secondary	KOOS - Sports & Recreation	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.	Baseline; 2 months, 4 months and 6 months from baseline
Secondary	KOOS - Quality of Life	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.	Baseline; 2 months, 4 months and 6 months from baseline
Secondary	Partners in Health Scale	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.	Baseline; 2 months, 4 months and 6 months from baseline

External Links

•   Study webpage