title: Feasibility and preliminary efficacy of a physical activity counseling intervention using Fitbit in people with knee osteoarthritis: the TRACK-OA study protocol.
abstract: BACKGROUND
  Physical activity (PA) reduces pain and improves functioning in people with knee osteoarthritis (OA), but few people with the condition meet recommended PA guidelines. Successful intervention strategies to increase PA include goal setting, action planning, self-monitoring, and follow-up feedback from a healthcare professional. Recently developed consumer wearable activity trackers allow users to set activity goals, self-monitor daily goal-progress, and provide feedback on goal attainment. It is hypothesized that a multi-component physiotherapist-led intervention that includes a short (40-min) education module, guided goal-setting and action planning, the use of a wristband activity tracker, and weekly follow-up phone calls will lead to increased PA outcomes.
  
  
  METHODS
  Thirty-six participants will be recruited from the community for a two-group pilot randomized controlled trial with a stepped-wedge design using an intention-to-treat analysis. Computer-generated block randomization will be performed using varying block sizes and a 1:1 allocation ratio. The 4-week intervention will be delivered immediately (immediate-intervention group) or after a 5-week delay (delayed-intervention group). Outcome measures of pain and disability (Knee Injury and OA Outcome Score), disease self-management ability (Partners in Health Scale), and objective bouted moderate-to-vigorous PA and sedentary time (BodyMedia SenseWear Mini Armband) will be collected at baseline (week 0) and two follow-ups (weeks 5 and 10), for a total study duration of 11 weeks. Feasibility data relating to process, resource, management, and scientific elements of the trial will be collected. Outcome measure and feasibility data will be summarized, and an estimate of intervention efficacy will be obtained by regression model with planned comparisons. The trial began recruiting in February 2015. To date, 34 subjects have been recruited.
  
  
  CONCLUSIONS
  This study will evaluate the feasibility and preliminary efficacy of a novel intervention to promote PA in people living with knee OA. The results will provide valuable information to inform a larger randomized trial to assess intervention effectiveness.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier: NCT02313506 (registration date 8 December 2014). First participant randomized 20 February 2015.
authors.affiliation: Arthritis Research Canada, Milan Ilich Arthritis Research Centre, 5591 No. 3 Road, Richmond, BC V6X 2C7 Canada ; Department of Physical Therapy, University of British Columbia, Friedman Building, 212-2177 Wesbrook Mall, Vancouver, BC V6T 1Z3 Canada.
authors.forename: Cam
authors.initials: C
authors.lastname: Clayton
authors.affiliation: Arthritis Research Canada, Milan Ilich Arthritis Research Centre, 5591 No. 3 Road, Richmond, BC V6X 2C7 Canada ; Department of Physical Therapy, University of British Columbia, Friedman Building, 212-2177 Wesbrook Mall, Vancouver, BC V6T 1Z3 Canada ; Rehabilitation Program, Fraser Health, Central City Office, 400-13450 102nd Avenue, Surrey, BC V3T 0H1 Canada.
authors.forename: Lynne
authors.initials: L
authors.lastname: Feehan
authors.affiliation: Arthritis Research Canada, Milan Ilich Arthritis Research Centre, 5591 No. 3 Road, Richmond, BC V6X 2C7 Canada ; Faculty of Health Sciences, Simon Fraser University, Blusson Hall, Room 9510, 8888 University Drive, Burnaby, BC V5A 1S6 Canada.
authors.forename: Charlie H
authors.initials: CH
authors.lastname: Goldsmith
authors.affiliation: Department of Occupational Science & Occupational Therapy, University of British Columbia, T325-2211 Wesbrook Mall, Vancouver, BC V6T 2B5 Canada.
authors.forename: William C
authors.initials: WC
authors.lastname: Miller
authors.affiliation: Arthritis Research Canada, Milan Ilich Arthritis Research Centre, 5591 No. 3 Road, Richmond, BC V6X 2C7 Canada.
authors.forename: Navi
authors.initials: N
authors.lastname: Grewal
authors.affiliation: Arthritis Research Canada, Milan Ilich Arthritis Research Centre, 5591 No. 3 Road, Richmond, BC V6X 2C7 Canada.
authors.forename: Joanna
authors.initials: J
authors.lastname: Ye
authors.affiliation: Arthritis Research Canada, Milan Ilich Arthritis Research Centre, 5591 No. 3 Road, Richmond, BC V6X 2C7 Canada.
authors.forename: Ju Young
authors.initials: JY
authors.lastname: Yoo
authors.affiliation: Arthritis Research Canada, Milan Ilich Arthritis Research Centre, 5591 No. 3 Road, Richmond, BC V6X 2C7 Canada ; Department of Physical Therapy, University of British Columbia, Friedman Building, 212-2177 Wesbrook Mall, Vancouver, BC V6T 1Z3 Canada.
authors.forename: Linda C
authors.initials: LC
authors.lastname: Li
keywords: Activity counseling; Feasibility; Knee osteoarthritis; Physical activity; Wearable activity tracker