Feasibility of a Wearable-enabled Intervention for Promoting Physical Activity in People Knee OA

Not Applicable

Completed

Conditions: Knee Osteoarthritis
Joint Diseases

Registration Number: NCT02313506

Lead Sponsor: University of British Columbia

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 34

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Time Spent in Moderate-to-Vigorous Physical Activity (MVPA)	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 Outcome Measures

Name	Time	Method
Time Spent in Sedentary Behavior	Baseline; 1 month and 2 months from baseline	We calculated the average daily time spent with an energy expenditure of 1.5 METs or lower, occurring in bouts of \> 20 minutes during waking hours.
KOOS - Symptoms	Baseline; 1 month and 2 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.
KOOS - Pain	Baseline; 1 month and 2 months from baseline	Pain was measured by a Knee Injury and Osteoarthritis Outcome Score subscale. Scores range from 0 to 100, with higher being better.
KOOS - Activities of Daily Living	Baseline; 1 month and 2 months from baseline	Activities 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 - Sport and Recreation Function	Baseline; 1 month and 2 months from baseline	Sport and Recreation Function 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 - Knee-related Quality of Life	Baseline; 1 month and 2 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.
Partners in Health Scale	Baseline; 1 month and 2 months from baseline	The Partners in Health Scale is a 12-item measure designed to assess disease self-management abilities including knowledge of health conditions, ability to participate in decision-making with health care professionals, and ability to pursue a healthy lifestyle. Scores range from 0 to 96, with lower being better.