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

• ClinicalTrials.gov Identifier: NCT02315664
• Recruitment Status: Completed
• First Posted: December 12, 2014
• Results First Posted: October 28, 2019
• Last Update Posted: October 28, 2019
• Sponsor: University of British Columbia
• Collaborators: Simon Fraser University; Arthritis Research Centre of Canada; Vancouver General Hospital
• Information provided by (Responsible Party): Linda Li, University of British Columbia

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Knee Osteoarthritis; Joint Diseases	Behavioral: Education session, Fitbit Flex, and remote coaching by a PT; Behavioral: Same intervention with a 2 month delay	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 61 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Improving Physical Activity Using an Online Monitoring Tool: a New Model of Care for Knee Osteoarthritis
• Actual Study Start Date: November 2, 2015
• Actual Primary Completion Date: May 17, 2017
• Actual Study Completion Date: May 25, 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	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.
Experimental: 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.	Behavioral: 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.

Outcome Measures

Primary Outcome Measures :

1. Time Spent in Moderate-to-Vigorous Physical Activity (MVPA) [ Time Frame: 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 Outcome Measures :

1. Time Spent in Sedentary Behaviors [ Time Frame: 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.
2. KOOS - Symptoms [ Time Frame: 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.
3. KOOS - Pain [ Time Frame: 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.
4. KOOS - Activity of Daily Living [ Time Frame: 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.
5. KOOS - Sports & Recreation [ Time Frame: 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.
6. KOOS - Quality of Life [ Time Frame: 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.
7. Partners in Health Scale [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 19 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

Canada, British Columbia

Arthritis Research Canada

Richmond, British Columbia, Canada, V6X 2C7

Sponsors and Collaborators

University of British Columbia

Simon Fraser University

Arthritis Research Centre of Canada

Vancouver General Hospital

Investigators

• Principal Investigator: Linda Li, PhD; Arthritis Research Canada

  Study Documents (Full-Text)

Documents provided by Linda Li, University of British Columbia:

Study Protocol and Statistical Analysis Plan  [PDF] February 18, 2016

More Information

Additional Information:

Study webpage 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• Responsible Party: Linda Li, Professor, University of British Columbia
• ClinicalTrials.gov Identifier: NCT02315664
• Other Study ID Numbers: H14-01762
• First Posted: December 12, 2014
• Results First Posted: October 28, 2019
• Last Update Posted: October 28, 2019
• Last Verified: September 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Linda Li, University of British Columbia:

Physical activity; Exercise; Osteoarthritis; Knee; Arthritis

Additional relevant MeSH terms:

Osteoarthritis; Osteoarthritis, Knee; Joint Diseases; Arthritis; Musculoskeletal Diseases; Rheumatic Diseases