Physical therapy vs. internet-based exercise training (PATH-IN) for XXXX with @entity626 : study protocol of a randomized controlled trial.

@entity1 @entity626 @entity308 @entity571 @entity158
BACKGROUND: Physical activity improves @entity158 and function among individuals with @entity626 ( @entity571 ), but most @entity1 with this condition are inactive. Physical therapists play a key role in helping @entity1 with knee @entity571 to increase appropriate physical activity. However, health care access issues, financial constraints, and other factors impede some @entity1 from receiving physical therapy (PT) for knee @entity571 . A need exists to develop and evaluate other methods to provide physical activity instruction and support to @entity1 with knee @entity571 . This study is examining the effectiveness of an internet-based exercise training (IBET) program designed for knee @entity571 , designed by physical therapists and other clinicians. METHODS/DESIGN: This is a randomized controlled trial of 350 @entity1 with symptomatic knee @entity571 , 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 @entity1 Centered Outcomes Research Institute, which conducted a peer review of the proposal. The IBET program provides @entity1 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 @entity571 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 @entity571 Index, and secondary outcomes include objective physical function, satisfaction with physical function, physical activity, @entity308 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 @entity571 ), and explore whether @entity1 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 @entity1 with knee @entity571 to adopt and maintain appropriate physical activity. This trial will provide an important evaluation of the effectiveness of this IBET program for knee @entity571 . TRIAL REGISTRATION: NCT02312713.
