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

NCT ID: NCT02315664

Last Updated: 2019-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-02
• Study Completion Date: 2017-05-25

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.

Conditions

Knee Osteoarthritis; Joint Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

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.

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.

Group Type: EXPERIMENTAL

Same intervention with a 2 month delay

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility 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)

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Simon Fraser University

OTHER

Sponsor Role: collaborator

Arthritis Research Centre of Canada

OTHER

Sponsor Role: collaborator

Vancouver General Hospital

OTHER

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Linda Li

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Linda Li, PhD

Role: PRINCIPAL_INVESTIGATOR

Arthritis Research Canada

Locations

Arthritis Research Canada

Richmond, British Columbia, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 30577819 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29712630 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://arthritis.rehab.med.ubc.ca/2015/03/03/improving-physical-activity-using-an-online-monitoring-tool-a-new-model-of-care-for-knee-osteoarthritis-monitor-oa/

Study webpage

Other Identifiers

H14-01762

Identifier Type: -

Identifier Source: org_study_id