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

Primary Purpose

Knee Osteoarthritis, Joint Diseases

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

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

Same intervention with a 2 month delay

About this trial

This is an interventional supportive care trial for Knee Osteoarthritis focused on measuring Physical activity, Exercise, Osteoarthritis, Knee, Arthritis

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

Arthritis Research Canada

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Immediate Intervention Group

Delayed Intervention Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT02315664

First Posted

November 17, 2014

Last Updated

October 24, 2019

Sponsor

University of British Columbia

Collaborators

Simon Fraser University, Arthritis Research Centre of Canada, Vancouver General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02315664

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Completed

Study Start Date

November 2, 2015 (Actual)

Primary Completion Date

May 17, 2017 (Actual)

Study Completion Date

May 25, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of British Columbia

Collaborators

Simon Fraser University, Arthritis Research Centre of Canada, Vancouver General Hospital

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Knee Osteoarthritis, Joint Diseases

Keywords

Physical activity, Exercise, Osteoarthritis, Knee, Arthritis

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

61 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Immediate Intervention Group

Arm Type

Experimental

Arm Description

Arm Title

Delayed Intervention Group

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

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

Intervention Description

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

Intervention Name(s)

Same intervention with a 2 month delay

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Baseline; 2 months, 4 months and 6 months from baseline

Secondary Outcome Measure Information:

Title

Time Spent in Sedentary Behaviors

Description

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.

Time Frame

Change from baseline in time spent sedentary behaviors at 2 months, 4 months, and 6 months.

Title

KOOS - Symptoms

Description

Time Frame

Baseline; 2 months, 4 months and 6 months from baseline

Title

KOOS - Pain

Description

Time Frame

Baseline; 2 months, 4 months and 6 months from baseline

Title

KOOS - Activity of Daily Living

Description

Time Frame

Baseline; 2 months, 4 months and 6 months from baseline

Title

KOOS - Sports & Recreation

Description

Time Frame

Baseline; 2 months, 4 months and 6 months from baseline

Title

KOOS - Quality of Life

Description

Time Frame

Baseline; 2 months, 4 months and 6 months from baseline

Title

Partners in Health Scale

Description

Time Frame

Baseline; 2 months, 4 months and 6 months from baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Linda Li, PhD

Organizational Affiliation

Arthritis Research Canada

Official's Role

Principal Investigator

Facility Information:

Facility Name

Arthritis Research Canada

City

Richmond

State/Province

British Columbia

ZIP/Postal Code

V6X 2C7

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

30577819

Citation

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.

Results Reference

derived

PubMed Identifier

29712630

Citation

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.

Results Reference

derived

Links:

URL

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/

Description

Study webpage

Learn more about this trial

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

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