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NCT02315664

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

Completed NA Results posted Last updated 28 October 2019
What this trial tests

NA trial testing Education session, Fitbit Flex, and remote coaching by a PT in Knee Osteoarthritis in 61 participants. Completed in 25 May 2017.

Timeline
2 November 2015
Primary endpoint
17 May 2017
25 May 2017

Quick facts

Lead sponsorUniversity of British Columbia
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingsingle
Primary purposesupportive care
Enrollment61
Start date2 November 2015
Primary completion17 May 2017
Estimated completion25 May 2017
Sites1 location across Canada

Drugs / interventions tested

Conditions studied

Sponsor

University of British Columbia

Who can join

19 and older, any sex, with Knee Osteoarthritis or Joint Diseases. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Baseline
GroupValue95% CI
Immediate Intervention Group62.1± 54.6
Delayed Intervention Group65.3± 77.4
2 months
GroupValue95% CI
Immediate Intervention Group75.5± 54.3
Delayed Intervention Group50.0± 46.8
4 months
GroupValue95% CI
Immediate Intervention Group62.6± 56.3
Delayed Intervention Group60.1± 76.8
6 months
GroupValue95% CI
Immediate Intervention Group65.6± 48.5
Delayed Intervention Group70.7± 71.9
Time Spent in Sedentary Behaviors Secondary · 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.

Baseline
GroupValue95% CI
Immediate Intervention Group464.1± 137.7
Delayed Intervention Group497.4± 200.7
2 months
GroupValue95% CI
Immediate Intervention Group437.6± 133.9
Delayed Intervention Group503.0± 160.7
4 months
GroupValue95% CI
Immediate Intervention Group505.9± 167.2
Delayed Intervention Group508.9± 189
6 months
GroupValue95% CI
Immediate Intervention Group435.8± 138.8
Delayed Intervention Group496.0± 179.5
KOOS - Symptoms Secondary · 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.

Baseline
GroupValue95% CI
Immediate Intervention Group59.8± 16.1
Delayed Intervention Group62.9± 17.2
2 months
GroupValue95% CI
Immediate Intervention Group62.6± 15.6
Delayed Intervention Group61.7± 14.5
4 months
GroupValue95% CI
Immediate Intervention Group62.4± 14.7
Delayed Intervention Group63.4± 16.7
6 months
GroupValue95% CI
Immediate Intervention Group62.1± 15.3
Delayed Intervention Group61.4± 19.8
KOOS - Pain Secondary · 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.

Baseline
GroupValue95% CI
Immediate Intervention Group66.2± 17.5
Delayed Intervention Group65.1± 17.9
2 months
GroupValue95% CI
Immediate Intervention Group70.9± 17
Delayed Intervention Group64.8± 14.6
4 months
GroupValue95% CI
Immediate Intervention Group67.5± 15.5
Delayed Intervention Group66.3± 15.2
6 months
GroupValue95% CI
Immediate Intervention Group68.6± 17.5
Delayed Intervention Group66.2± 16.4
KOOS - Activity of Daily Living Secondary · 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.

Baseline
GroupValue95% CI
Immediate Intervention Group71.8± 17.5
Delayed Intervention Group74.1± 17.6
2 months
GroupValue95% CI
Immediate Intervention Group76± 16.1
Delayed Intervention Group71± 16.5
4 months
GroupValue95% CI
Immediate Intervention Group76.6± 17.5
Delayed Intervention Group75.2± 17.2
6 months
GroupValue95% CI
Immediate Intervention Group75.1± 15.9
Delayed Intervention Group73.9± 15.8
KOOS - Sports & Recreation Secondary · 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.

Baseline
GroupValue95% CI
Immediate Intervention Group47.3± 26.6
Delayed Intervention Group52.7± 27.7
2 months
GroupValue95% CI
Immediate Intervention Group49.3± 24.9
Delayed Intervention Group47± 23.3
4 months
GroupValue95% CI
Immediate Intervention Group50± 25.6
Delayed Intervention Group48.9± 27.7
6 months
GroupValue95% CI
Immediate Intervention Group50.4± 26.3
Delayed Intervention Group49.8± 29.2
KOOS - Quality of Life Secondary · 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.

Baseline
GroupValue95% CI
Immediate Intervention Group41± 19.8
Delayed Intervention Group44.6± 16.3
2 months
GroupValue95% CI
Immediate Intervention Group47.2± 18.9
Delayed Intervention Group42.4± 16.8
4 months
GroupValue95% CI
Immediate Intervention Group45.4± 17.6
Delayed Intervention Group47.5± 13.6
6 months
GroupValue95% CI
Immediate Intervention Group44.9± 17.9
Delayed Intervention Group48.1± 19.1
Partners in Health Scale Secondary · 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.

Baseline
GroupValue95% CI
Immediate Intervention Group18.4± 12.6
Delayed Intervention Group20.5± 12.8
2 months
GroupValue95% CI
Immediate Intervention Group14.9± 11.4
Delayed Intervention Group18.3± 13.7
4 months
GroupValue95% CI
Immediate Intervention Group14.3± 10.1
Delayed Intervention Group14.9± 9.6
6 months
GroupValue95% CI
Immediate Intervention Group12.9± 9.2
Delayed Intervention Group13.1± 9.2

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. A Community-Based Physical Activity Counselling Program for People With Knee Osteoarthritis: Feasibility and Preliminary Efficacy of the Track-OA Study.
    Li LC, Sayre EC, Xie H, Xie H, et al · · 2017 · cited 53× · PMID 28652228 · DOI 10.2196/mhealth.7863
  2. Efficacy of a Community-Based Technology-Enabled Physical Activity Counseling Program for People With Knee Osteoarthritis: Proof-of-Concept Study.
    Li LC, Sayre EC, Xie H, Xie H, et al · · 2018 · cited 49× · PMID 29712630 · DOI 10.2196/jmir.8514
  3. 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.
    Falck RS, Best JR, Li LC, Chan PCY, et al · · 2018 · cited 16× · PMID 30577819 · DOI 10.1186/s12891-018-2369-z
  4. Experiences of Wearable Technology by Persons with Knee Osteoarthritis Participating in a Physical Activity Counseling Intervention: Qualitative Study Using a Relational Ethics Lens.
    Leese J, MacDonald G, Backman CL, Townsend A, et al · · 2021 · cited 9× · PMID 34766912 · DOI 10.2196/30332
  5. Cross-sectional and longitudinal neural predictors of physical activity and sedentary behaviour from a 6-month randomized controlled trial.
    Falck RS, Hsu CL, Best JR, Boa Sorte Silva NC, et al · · 2024 · cited 6× · PMID 38195673 · DOI 10.1038/s41598-023-48715-z

Verify or expand the search:

Other recruiting trials for Knee Osteoarthritis

Currently open trials in the same condition.

Other University of British Columbia trials

Trials by the same sponsor.

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