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

Not Applicable

Completed

• Conditions: Knee Osteoarthritis; Joint Diseases
• Interventions: Behavioral: Education session, Fitbit Flex, and remote coaching by a PT; Behavioral: Same intervention with a 1 month delay

• 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.

Study Timeline

• Study First Submitted: 2014-12-08
• Study First Submitted QC: 2014-12-09
• Study First Posted: 2014-12-10
• Study Start: 2015-01
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Results First Submitted: 2017-10-23
• Status Verified: 2019-09
• Results First Submitted QC: 2019-10-29
• Last Update Submitted: 2019-10-29
• Results First Posted: 2019-11-19
• Last Update Posted: 2019-11-19

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.

Read More

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)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Immediate Intervention Group	Education session, Fitbit Flex, and remote coaching by a PT	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. At the end of the education session, the PT will help participants set personal activity goals. In Month 1, participants will use the Fitbit Flex. The PT will review the progress with participants via 20-minute weekly phone calls and progressively modify their activities. In Month 2, they will continue using the Fitbit and have access to a PT via email as needed, but no weekly phone calls.
Delayed Intervention Group	Same intervention with a 1 month delay	Same intervention with a 1 month delay: The full intervention will be initiated in Month 2 with a brief education session, use of Fitbit Flex, and counselling by a physiotherapist. The trial will conclude at the end of Month 2.

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
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.
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 - 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.

Trial Locations

Locations (1)

Arthritis Research Canada; 🇨🇦 Richmond, British Columbia, Canada