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01.12.2015 | Study protocol | Ausgabe 1/2015 Open Access

BMC Musculoskeletal Disorders 1/2015

Physical therapy vs. internet-based exercise training (PATH-IN) for patients with knee osteoarthritis: study protocol of a randomized controlled trial

Zeitschrift:
BMC Musculoskeletal Disorders > Ausgabe 1/2015
Autoren:
Quinn I. Williams, Alexander H. Gunn, John E. Beaulieu, Bernadette C. Benas, Bruce Buley, Leigh F. Callahan, John Cantrell, Andrew P. Genova, Yvonne M. Golightly, Adam P. Goode, Christopher I. Gridley, Michael T. Gross, Bryan C. Heiderscheit, Carla H. Hill, Kim M. Huffman, Aaron Kline, Todd A. Schwartz, Kelli D. Allen
Wichtige Hinweise

Competing interests

Visual Health Information, Inc (VHI) owns the website used in the current manuscript, of which Beaulieu is the president/CEO. Heiderscheit has received consulting fees from VHI for work unrelated to this manuscript. A patent related to the website described in this manuscript is currently under review.

Authors’ contributions

QW, AHG, and BCB contribute to data acquisition and study coordination and helped draft the manuscript. KA, LF, KH, YMG, APG (Genova), APG (Goode), MG, CH, AK, CG, BB contributed to the study design and protocol and helped draft the manuscript. KA contributed the conception of the study design and helped draft the manuscript. JB and BH contributed to the original design and evaluation of the exercise website and helped draft the manuscript. TS and JC contributed to plans for statistical analyses and helped draft the manuscript. All authors read and approved the final manuscript.

Authors’ information

Not applicable.

Availability of data and materials

Not applicable.

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/Design

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.

Discussion

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.

Trial registration

Literatur
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