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Clinical Trials/NCT02313506
NCT02313506
Completed
Not Applicable

Feasibility and Preliminary Efficacy of an Activity Tracker-driven Intervention for Promoting Physical Activity in People Living With Osteoarthritis of the Knee

University of British Columbia1 site in 1 country34 target enrollmentJanuary 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Knee Osteoarthritis
Sponsor
University of British Columbia
Enrollment
34
Locations
1
Primary Endpoint
Time Spent in Moderate-to-Vigorous Physical Activity (MVPA)
Status
Completed
Last Updated
6 years ago

Overview

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 pilot randomized controlled trail is to assess the feasibility and preliminary efficacy of a multi-component intervention/model of care involving a group education session, use of the Fitbit Flex (a wireless physical activity tracking device), and weekly telephone counselling by a physiotherapist (PT) to improve physical activity and reduce sedentary time in patients with knee OA.

Detailed Description

Knee osteoarthritis (OA) is common (affecting 1 in 10), painful, and debilitating. Being physically active improves pain, mobility and quality of life for people living with knee OA; 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. The investigators primary objective is to determine the feasibility and preliminary efficacy of a multi-component model of care involving 1) a group education and structured goal-setting session, 2) the use of Fitbit Flex (a commercially available physical activity tracker) and 3) weekly telephone activity counselling by a physiotherapist for improving physical activity and reducing sedentary time in patients with knee OA. In this pilot randomized controlled trial 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 OA disease status, and 4) improve abilities to self-manage their condition.

Registry
clinicaltrials.gov
Start Date
January 2015
End Date
June 2015
Last Updated
6 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Linda Li

Professor

University of British Columbia

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 2-hour education session at the Mary Pack Arthritis Centre.

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)

Outcomes

Primary Outcomes

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

Time Frame: Baseline; 1 month and 2 months from baseline

Participants wore a SenseWear Mini device for 7 days at baseline, and Months 1 and 2. We calculated the average time spent in MVPA accumulated in bouts per day. A bout is defined as 10 consecutive minutes or more at the level of 3 or higher METs, with allowance for interruption of up to 1 minute below the threshold.

Secondary Outcomes

  • Time Spent in Sedentary Behavior(Baseline; 1 month and 2 months from baseline)
  • KOOS - Symptoms(Baseline; 1 month and 2 months from baseline)
  • KOOS - Pain(Baseline; 1 month and 2 months from baseline)
  • KOOS - Activities of Daily Living(Baseline; 1 month and 2 months from baseline)
  • KOOS - Sport and Recreation Function(Baseline; 1 month and 2 months from baseline)
  • KOOS - Knee-related Quality of Life(Baseline; 1 month and 2 months from baseline)
  • Partners in Health Scale(Baseline; 1 month and 2 months from baseline)

Study Sites (1)

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