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

Primary Purpose

Knee Osteoarthritis, Joint Diseases

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Education session, Fitbit Flex, and remote coaching by a PT
Same intervention with a 1 month delay
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Knee Osteoarthritis focused on measuring Physical activity, Exercise, Osteoarthritis, Knee, Arthritis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Arthritis Research Canada

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Immediate Intervention Group

Delayed Intervention Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
KOOS - Pain
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
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
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
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
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.

Full Information

First Posted
December 8, 2014
Last Updated
October 29, 2019
Sponsor
University of British Columbia
Collaborators
Arthritis Research Centre of Canada, Vancouver General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02313506
Brief Title
Feasibility of a Wearable-enabled Intervention for Promoting Physical Activity in People Knee OA
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
Arthritis Research Centre of Canada, Vancouver General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Joint Diseases
Keywords
Physical activity, Exercise, Osteoarthritis, Knee, Arthritis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
This study used a delayed control design.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate Intervention Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Delayed Intervention Group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Education session, Fitbit Flex, and remote coaching by a PT
Intervention Description
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
Intervention Name(s)
Same intervention with a 1 month delay
Intervention Description
The Delayed Intervention Group will receive the same intervention as the Immediate Intervention Group, but with a 1 Month delay.
Primary Outcome Measure Information:
Title
Time Spent in Moderate-to-Vigorous Physical Activity (MVPA)
Description
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.
Time Frame
Baseline; 1 month and 2 months from baseline
Secondary Outcome Measure Information:
Title
Time Spent in Sedentary Behavior
Description
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.
Time Frame
Baseline; 1 month and 2 months from baseline
Title
KOOS - Symptoms
Description
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 Frame
Baseline; 1 month and 2 months from baseline
Title
KOOS - Pain
Description
Pain was measured by a Knee Injury and Osteoarthritis Outcome Score subscale. Scores range from 0 to 100, with higher being better.
Time Frame
Baseline; 1 month and 2 months from baseline
Title
KOOS - Activities of Daily Living
Description
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.
Time Frame
Baseline; 1 month and 2 months from baseline
Title
KOOS - Sport and Recreation Function
Description
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.
Time Frame
Baseline; 1 month and 2 months from baseline
Title
KOOS - Knee-related Quality of Life
Description
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.
Time Frame
Baseline; 1 month and 2 months from baseline
Title
Partners in Health Scale
Description
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.
Time Frame
Baseline; 1 month and 2 months from baseline

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda Li, PT, PhD
Organizational Affiliation
Arthritis Research Canada; University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arthritis Research Canada
City
Richmond
State/Province
British Columbia
ZIP/Postal Code
V6X 2C7
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28652228
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.
Results Reference
derived
PubMed Identifier
27965808
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.
Results Reference
derived
Links:
URL
http://arthritis.rehab.med.ubc.ca/2015/02/04/improving-physical-activity-using-a-wearable-activity-tracker-pilot-testing-a-new-model-of-care-for-knee-osteoarthritis-track-oa/
Description
Study webpage

Learn more about this trial

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

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