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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Knee Osteoarthritis Joint Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This study used a delayed control design.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Immediate Intervention Group

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.

Group Type ACTIVE_COMPARATOR

Education session, Fitbit Flex, and remote coaching by a PT

Intervention Type BEHAVIORAL

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.

Delayed Intervention Group

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.

Group Type PLACEBO_COMPARATOR

Same intervention with a 1 month delay

Intervention Type BEHAVIORAL

The Delayed Intervention Group will receive the same intervention as the Immediate Intervention Group, but with a 1 Month delay.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)

Eligible Sex

ALL

Accepts Healthy Volunteers

No