Clinical Trial Protocol
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Effects of early home-based strength and sensory-motor training after total hip arthroplasty: study protocol for a multicenter randomized controlled trial.

Trials 2022 November 9
BACKGROUND: Total hip arthroplasty (THA) is very effective in alleviating pain, but functional deficits persist up to a year following surgery. Regardless of standard physiotherapy programs, significant additional muscular atrophy and weakness occur. Deficits in strength have serious adverse consequences for these patients with respect to physical function, the maintenance of independence, and the requirement for revision surgery. Progressive resistance training in rehabilitation following THA has been shown to significantly enhance muscle strength and function. The fundamental principle is to progressively overload the exercised muscle as it becomes stronger. Different strength training protocols have been used at different times in the postoperative phase, in group or individual practices, with major differences being in center-based and home-based programs with or without supervision. The primary objective of our study is to evaluate whether an early postoperative home-based strength training protocol can improve patient functional outcomes at 3 months and 1 year following surgery. Secondary objectives are the feasibility of the presented protocol for all elective THA patients and its safety.

METHODS/DESIGN: This study is a prospective multicenter randomized clinical trial to be conducted in the orthopedic departments of two Slovenian hospitals. In each hospital, 124 patients aged 60 or older with unilateral osteoarthritis, an ASA score between 1 and 3, a signed informed consent form, and no terminal illness disabling rehabilitation participation will be randomly assigned to the intervention or control group. THA with an anterior approach will be performed. All patients will receive current standard physiotherapy during hospitalization. Patients in the intervention group will also learn strength and sensory-motor training exercises. Upon discharge, all will receive USB drives with exercise videos, written exercise instructions, and a training diary. Physiotherapists will perform the assessments (physical tests and the maximal voluntary isometric contraction assessment), and patients will fill out outcome assessment questionnaires (the Harris Hip Score and 36-Item Short Form Health Survey) at baseline and 1, 3, and 12 months after surgery.

DISCUSSION: The main purpose of our study is to design a new standardized rehabilitation protocol with videos that will be effective, safe, and accessible to all Slovenian THA patients.

TRIAL REGISTRATION: ClinicalTrials.gov NCT04061993 . Registered on 07 November 2019. Protocol ID: PRT_PhD. Version 1.

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