Clinical trial NCT02313506: Feasibility of a Wearable-enabled Intervention for Promoting Physical Activity in People Knee 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Joint Diseases
Keywords: Physical activity
Exercise
Osteoarthritis
Knee
Arthritis
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Arthritis Research Centre of Canada
name: Vancouver General Hospital
First posted: 2014-12-10
Enrollment: 34
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This study used a delayed control design.
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: Time Spent in Moderate-to-Vigorous Physical Activity (MVPA)
timeFrame: Baseline; 1 month and 2 months from baseline
Secondary outcomes:
measure: Time Spent in Sedentary Behavior
timeFrame: Baseline; 1 month and 2 months from baseline
measure: KOOS - Symptoms
timeFrame: Baseline; 1 month and 2 months from baseline
measure: KOOS - Pain
timeFrame: Baseline; 1 month and 2 months from baseline
measure: KOOS - Activities of Daily Living
timeFrame: Baseline; 1 month and 2 months from baseline
measure: KOOS - Sport and Recreation Function
timeFrame: Baseline; 1 month and 2 months from baseline
measure: KOOS - Knee-related Quality of Life
timeFrame: Baseline; 1 month and 2 months from baseline
measure: Partners in Health Scale
timeFrame: Baseline; 1 month and 2 months from baseline
Other outcomes:
Locations:
city: Richmond
country: Canada
facility: Arthritis Research Canada
state: British Columbia
Study officials:
affiliation: Arthritis Research Canada; University of British Columbia
name: Linda Li, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li LC, Sayre EC, Xie H, Clayton C, Feehan LM. A Community-Based Physical Activity Counselling Program for People With Knee Osteoarthritis: Feasibility and Preliminary Efficacy of the Track-OA Study. JMIR Mhealth Uhealth. 2017 Jun 26;5(6):e86. doi: 10.2196/mhealth.7863.
citation: Clayton C, Feehan L, Goldsmith CH, Miller WC, Grewal N, Ye J, Yoo JY, Li LC. Feasibility and preliminary efficacy of a physical activity counseling intervention using Fitbit in people with knee osteoarthritis: the TRACK-OA study protocol. Pilot Feasibility Stud. 2015 Aug 22;1:30. doi: 10.1186/s40814-015-0027-x. eCollection 2015.