title: Physical therapy vs. internet-based exercise training (PATH-IN) for patients with knee osteoarthritis: study protocol of a randomized controlled trial.
abstract: BACKGROUND
  Physical activity improves pain and function among individuals with knee osteoarthritis (OA), but most people with this condition are inactive. Physical therapists play a key role in helping people with knee OA to increase appropriate physical activity. However, health care access issues, financial constraints, and other factors impede some patients from receiving physical therapy (PT) for knee OA. A need exists to develop and evaluate other methods to provide physical activity instruction and support to people with knee OA. This study is examining the effectiveness of an internet-based exercise training (IBET) program designed for knee OA, designed by physical therapists and other clinicians.
  
  
  METHODS
  This is a randomized controlled trial of 350 participants with symptomatic knee OA, allocated to three groups: IBET, standard PT, and a wait list (WL) control group (in a 2:2:1 ratio, respectively). The study was funded by the Patient Centered Outcomes Research Institute, which conducted a peer review of the proposal. The IBET program provides patients with a tailored exercise program (based on functional level, symptoms, and current activity), video demonstrations of exercises, and guidance for appropriate exercise progression. The PT group receives up to 8 individual visits with a physical therapist, mirroring standard practice for knee OA and with an emphasis on a home exercise program. Outcomes are assessed at baseline, 4 months (primary time point) and 12 months (to assess maintenance of treatment effects). The primary outcome is the Western Ontario and McMaster Universities Osteoarthritis Index, and secondary outcomes include objective physical function, satisfaction with physical function, physical activity, depressive symptoms and global assessment of change. Linear mixed models will be used to compare both the IBET and standard PT groups to the WL control group, examine whether IBET is non-inferior to PT (a treatment that has an established evidence base for knee OA), and explore whether participant characteristics are associated with differential effects of IBET and/or standard PT. This research is in compliance with the Helsinki Declaration and was approved by the Institutional Review Board of the University of North Carolina at Chapel Hill.
  
  
  CONCLUSIONS
  The IBET program could be disseminated widely at relatively low cost and could be an important resource for helping patients with knee OA to adopt and maintain appropriate physical activity. This trial will provide an important evaluation of the effectiveness of this IBET program for knee OA.
  
  
  BACKGROUND
  NCT02312713.
authors.affiliation: Thurston Arthritis Research Center, University of North Carolina at Chapel Hill, 3300 Thurston Bldg., CB# 7280, Chapel Hill, NC, 27599, USA. qwilliams@unc.edu.|Department of Medicine, University of North Carolina at Chapel Hill, 125 MacNider Hall CB# 7005, Chapel Hill, NC, 27599, USA. qwilliams@unc.edu.
authors.forename: Quinn I
authors.initials: QI
authors.lastname: Williams
authors.affiliation: Thurston Arthritis Research Center, University of North Carolina at Chapel Hill, 3300 Thurston Bldg., CB# 7280, Chapel Hill, NC, 27599, USA. agunn@unc.edu.|Department of Medicine, University of North Carolina at Chapel Hill, 125 MacNider Hall CB# 7005, Chapel Hill, NC, 27599, USA. agunn@unc.edu.
authors.forename: Alexander H
authors.initials: AH
authors.lastname: Gunn
authors.affiliation: Visual Health Information, Inc., Tacoma, WA, USA. johnb@vhikits.com.
authors.forename: John E
authors.initials: JE
authors.lastname: Beaulieu
authors.affiliation: Thurston Arthritis Research Center, University of North Carolina at Chapel Hill, 3300 Thurston Bldg., CB# 7280, Chapel Hill, NC, 27599, USA. bcbenas@email.unc.edu.|Department of Medicine, University of North Carolina at Chapel Hill, 125 MacNider Hall CB# 7005, Chapel Hill, NC, 27599, USA. bcbenas@email.unc.edu.
authors.forename: Bernadette C
authors.initials: BC
authors.lastname: Benas
authors.affiliation: Comprehensive Physical Therapy Center, Chapel Hill, NC, USA. brucebuley@gmail.com.
authors.forename: Bruce
authors.initials: B
authors.lastname: Buley
authors.affiliation: Thurston Arthritis Research Center, University of North Carolina at Chapel Hill, 3300 Thurston Bldg., CB# 7280, Chapel Hill, NC, 27599, USA. leigh_callahan@med.unc.edu.|Department of Medicine, University of North Carolina at Chapel Hill, 125 MacNider Hall CB# 7005, Chapel Hill, NC, 27599, USA. leigh_callahan@med.unc.edu.
authors.forename: Leigh F
authors.initials: LF
authors.lastname: Callahan
authors.affiliation: Thurston Arthritis Research Center, University of North Carolina at Chapel Hill, 3300 Thurston Bldg., CB# 7280, Chapel Hill, NC, 27599, USA. john_cantrell@unc.edu.|Injury Prevention Research Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA. john_cantrell@unc.edu.
authors.forename: John
authors.initials: J
authors.lastname: Cantrell
authors.affiliation: Comprehensive Physical Therapy Center, Chapel Hill, NC, USA. agcptc@bellsouth.net.
authors.forename: Andrew P
authors.initials: AP
authors.lastname: Genova
authors.affiliation: Thurston Arthritis Research Center, University of North Carolina at Chapel Hill, 3300 Thurston Bldg., CB# 7280, Chapel Hill, NC, 27599, USA. golight@email.unc.edu.|Injury Prevention Research Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA. golight@email.unc.edu.|Department of Epidemiology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA. golight@email.unc.edu.
authors.forename: Yvonne M
authors.initials: YM
authors.lastname: Golightly
authors.affiliation: Department of Orthopedic Surgery, Division of Physical Therapy, Duke University Medical Center, Durham, NC, USA. adam.goode@duke.edu.
authors.forename: Adam P
authors.initials: AP
authors.lastname: Goode
authors.affiliation: Advanced Physical Therapy of Smithfield, Smithfield, NC, USA. cgridley@advancedptofsmithfield.com.
authors.forename: Christopher I
authors.initials: CI
authors.lastname: Gridley
authors.affiliation: Division of Physical Therapy, Department of Allied Health Sciences, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA. mike_gross@med.unc.edu.
authors.forename: Michael T
authors.initials: MT
authors.lastname: Gross
authors.affiliation: Department of Orthopedics and Rehabilitation, University of Wisconsin-Madison, Madison, WI, USA. heiderscheit@pt.wisc.edu.
authors.forename: Bryan C
authors.initials: BC
authors.lastname: Heiderscheit
authors.affiliation: Division of Physical Therapy, Department of Allied Health Sciences, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA. carla_hill@med.unc.edu.
authors.forename: Carla H
authors.initials: CH
authors.lastname: Hill
authors.affiliation: Department of Medicine, Division of Rheumatology, Duke University Medical Center, Durham, NC, USA. kim.huffman@duke.edu.|Physical Medicine and Rehabilitation Service, Durham VA Medical Center, Durham, NC, USA. kim.huffman@duke.edu.
authors.forename: Kim M
authors.initials: KM
authors.lastname: Huffman
authors.affiliation: Advanced Physical Therapy of Smithfield, Smithfield, NC, USA. Akline@advancedptofsmithfield.com.
authors.forename: Aaron
authors.initials: A
authors.lastname: Kline
authors.affiliation: Thurston Arthritis Research Center, University of North Carolina at Chapel Hill, 3300 Thurston Bldg., CB# 7280, Chapel Hill, NC, 27599, USA. Todd_Schwartz@unc.edu.|Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA. Todd_Schwartz@unc.edu.|School of Nursing, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA. Todd_Schwartz@unc.edu.
authors.forename: Todd A
authors.initials: TA
authors.lastname: Schwartz
authors.affiliation: Thurston Arthritis Research Center, University of North Carolina at Chapel Hill, 3300 Thurston Bldg., CB# 7280, Chapel Hill, NC, 27599, USA. kdallen@email.unc.edu.|Department of Medicine, University of North Carolina at Chapel Hill, 125 MacNider Hall CB# 7005, Chapel Hill, NC, 27599, USA. kdallen@email.unc.edu.|Center for Health Services Research in Primary Care, Durham VA Medical Center, Durham, NC, USA. kdallen@email.unc.edu.
authors.forename: Kelli D
authors.initials: KD
authors.lastname: Allen
mesh_terms: D005081:Exercise Therapy; D006801:Humans; D020407:Internet; D020370:Osteoarthritis, Knee / Q000628:therapy*; D017063:Outcome Assessment, Health Care / Q000379:methods; D012107:Research Design