ProtocolInternational Journal of Clinical Trials

Publication:
Home-based prehabilitation before total knee arthroplasty: a randomized controlled trial protocol on feasibility and functional outcomes

Int J Clin Trials. 2025;12(4):297-303.DOI10.18203/2349-3259.ijct20253335

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Abstract

Background Total knee arthroplasty is a common surgical intervention for patients with end-stage knee osteoarthritis. Prehabilitation programs have been shown to improve postoperative outcomes, however, access to in-person rehabilitation remains a barrier for many patients. Home-based exercise programs may offer a viable alternative to improve preoperative physical function and optimize recovery.

Methods This study describes the protocol for a randomized controlled trial evaluating the feasibility and effects of a home-based prehabilitation intervention on physical function recovery for patients awaiting total knee arthroplasty. This is a prospective, two-arm, parallel-group, superiority randomized controlled trial, conducted at a national referral hospital. Patients scheduled for primary total knee arthroplasty will be randomized into either an experimental group receiving a structured home-based exercise program or a control group receiving standard hospital instructions. The intervention will be remotely monitored through digital communication tools. Feasibility outcomes include adherence rates and the occurrence of adverse events, while the study also assesses functional performance measures [Timed up and go test (TUG), sit-to-stand test], self-reported pain and function (WOMAC), postural balance, and knee extensor torque. Statistical analyses will be performed using a linear mixed-effects model (LMM) to assess intervention effects over time.

Conclusions This trial will provide essential data on the implementation of home-based prehabilitation and its potential to improve access to rehabilitation for patients with limited healthcare resources. If feasible, this approach could be integrated into standard preoperative care, reducing barriers to rehabilitation and enhancing post-surgical recovery. Trial registration: Approval from the local ethics committee (7.098.085) and was registered at clinicaltrials.gov (RBR-3m77djm).

Keywords

Affiliations

  1. National Institute of Traumatology and Orthopedics-INTO, Rio de Janeiro, Brazil

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