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

Knee Osteoarthritis Clinical Trial

— TRACK-OA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02313506
• Other study ID #: H14-02631
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: June 2015

Study information

• Verified date: September 2019
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Joint Diseases
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Behavioral:
• Education session, Fitbit Flex, and remote coaching by a PT
Participants will receive a brief education session, use of a commercially available physical activity tracker (Fitbit Flex), and remote counselling by a PT. Intervention will be received immediately.
• Same intervention with a 1 month delay
The Delayed Intervention Group will receive the same intervention as the Immediate Intervention Group, but with a 1 Month delay.

Locations

Country	Name	City	State
Canada	Arthritis Research Canada	Richmond	British Columbia

Sponsors (3)

Lead Sponsor	Collaborator
University of British Columbia	Arthritis Research Centre of Canada, Vancouver General Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time Spent in Moderate-to-Vigorous Physical Activity (MVPA)	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.	Baseline; 1 month and 2 months from baseline
Secondary	Time Spent in Sedentary Behavior	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.	Baseline; 1 month and 2 months from baseline
Secondary	KOOS - Symptoms	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; 1 month and 2 months from baseline
Secondary	KOOS - Pain	Pain was measured by a Knee Injury and Osteoarthritis Outcome Score subscale. Scores range from 0 to 100, with higher being better.	Baseline; 1 month and 2 months from baseline
Secondary	KOOS - Activities of Daily Living	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.	Baseline; 1 month and 2 months from baseline
Secondary	KOOS - Sport and Recreation Function	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.	Baseline; 1 month and 2 months from baseline
Secondary	KOOS - Knee-related Quality of Life	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; 1 month and 2 months from baseline
Secondary	Partners in Health Scale	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.	Baseline; 1 month and 2 months from baseline

External Links

•   Study webpage