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

NCT02315664 | Completed Results

• 1 other identifier: H14-01762
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis; Joint Diseases

Keywords

Physical activity; Exercise; Osteoarthritis; Knee; Arthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Time Spent in Sedentary Behaviors

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

• KOOS - Symptoms

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

• KOOS - Pain

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

• KOOS - Activity of Daily Living

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

• KOOS - Sports & Recreation

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

Study Arms (2)

Immediate Intervention Group

EXPERIMENTAL

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

Delayed Intervention Group

EXPERIMENTAL

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

Interventions

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

Immediate Intervention Group

Same intervention with a 2 month delay BEHAVIORAL

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

Delayed Intervention Group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of British Columbia: lead
• Simon Fraser University: collaborator
• Arthritis Research Centre of Canada: collaborator
• Vancouver General Hospital: collaborator

Study Sites (1)

Arthritis Research Canada

Richmond, British Columbia, V6X 2C7, Canada

Location

Related Publications (2)

• 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.

  PMID: 30577819 DERIVED

• 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.

  PMID: 29712630 DERIVED

Related Links

• Study webpage

MeSH Terms

Conditions

Osteoarthritis, Knee; Joint Diseases; Motor Activity; Osteoarthritis; Arthritis

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Rheumatic Diseases; Behavior

Limitations and Caveats

Our sample was relatively active; hence, the results may not be generalizable to people with knee OA who are more sedentary. Also, the long-term effect of the intervention remained unclear.

Results Point of Contact

• Title: Dr. Linda Li, Professor, University of British Columbia
• Organization: Arthritis Research Canada

lli@arthritisresearch.ca

604-207-4020

Study Officials

• Linda Li, PhD

  Arthritis Research Canada

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 17, 2014
• First Posted: December 12, 2014
• Study Start: November 2, 2015
• Primary Completion: May 17, 2017
• Study Completion: May 25, 2017
• Last Updated: October 28, 2019
• Results First Posted: October 28, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)