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Pragmatic Home-Based Exercise after Total Hip Arthroplasty - Silkeborg: Protocol for a prospective cohort study (PHETHAS-1).

ABSTRACT: Introduction: Rehabilitation exercises are offered to patients after total hip arthroplasty (THA); however, the effectiveness and optimal type and dose of exercise remains unknown. The primary objective of this trial is to indicate the preliminary efficacy of home-based rehabilitation using elastic band exercise on performance-based function after THA, based on the relationship between the performed exercise dose and the change in performance-based function (gait speed) from 3 (start of intervention) to 10 weeks (end of intervention) after surgery. The secondary objective is to investigate if a dose-response relationship exists between the performed exercise dose and changes in: hip-related disability, lower-extremity functional performance, and hip muscle strength Methods: In this prospective cohort study, patients scheduled for THA will be consecutively included until 88 have completed the intervention period from 3 to 10 weeks postoperatively. Participants perform the standard rehabilitation program with elastic band exercises. Exercise dose (exposure) will be objectively quantified using a sensor attached to the elastic band. The primary outcome is gait speed measured by the 40-m fast-paced walk test. Secondary outcomes include: patient reported hip disability (Hip disability and Osteoarthritis Outcome Score (HOOS)), hip muscle strength (hand-held dynamometry) and lower extremity function (30-s chair stand test). Discussion: This trial will add knowledge concerning the relationship between performed exercise dose and post-operative outcomes after THA. The protocol paper describes the study design and methods in detail, including the statistical analysis plan. Trial registration: Pre-registered on March 27, 2017 at ClinicalTrails.gov (ID: NCT03109821).

SUBMITTER: Mikkelsen LR

PROVIDER: S-EPMC6694449 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Pragmatic Home-Based Exercise after Total Hip Arthroplasty - Silkeborg: Protocol for a prospective cohort study (PHETHAS-1).

Mikkelsen Lone Ramer LR Madsen Merete Nørgaard MN Rathleff Michael Skovdal MS Thorborg Kristian K Rossen Camilla Blach CB Kallemose Thomas T Bandholm Thomas T

F1000Research 20190625

<b>Introduction:</b> Rehabilitation exercises are offered to patients after total hip arthroplasty (THA); however, the effectiveness and optimal type and dose of exercise remains unknown. The primary objective of this trial is to indicate the preliminary efficacy of home-based rehabilitation using elastic band exercise on performance-based function after THA, based on the relationship between the performed exercise dose and the change in performance-based function (gait speed) from 3 (start of i ...[more]

PMID: 31448107

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Project description:BackgroundRobotic-arm assisted surgery aims to reduce manual errors and improve the accuracy of implant positioning during total hip arthroplasty. The objective of this study is to compare the accuracy of implant positioning, restoration of hip biomechanics, patient satisfaction, functional outcomes, implant survivorship, cost-effectiveness, and complications in conventional manual total hip arthroplasty (CO THA) versus robotic-arm assisted total hip arthroplasty (RO THA). Preoperative pelvic computerised tomography (CT) scans will be used to create patient-specific, virtual, three-dimensional reconstructions for surgical planning in both treatment groups.Methods and analysisThis prospective randomised controlled trial will include 60 patients with symptomatic hip osteoarthritis undergoing primary THA. Following informed consent, patients will be randomised to CO THA (control group) or RO THA (investigation group) at a ratio of 1:1 using an online random number generator. Observers will review patients at regular intervals for 2 years after surgery to record predefined study outcomes relating to the accuracy of implant positioning, hip biomechanics, postoperative rehabilitation, clinical progress, functional outcomes, cost-effectiveness, and complications. Primary and secondary objectives will be used to quantify and draw inferences on differences in the efficacy of treatment between the two groups. Intention-to-treat and per-protocol population analysis will be undertaken. Intention to treat relates to the allocated treatment (CO THA or RO THA), and per-protocol refers to the actual treatment received by the patient. The following statistical methods will be employed to analyse the data: descriptive statistics, independent t test, paired t test, analysis of variance, Fisher exact test, chi-square test, and graphical displays. Ethical approval was obtained from the London-Bromley Research Ethics Committee, UK. The study is sponsored by University College London, UK.DiscussionThis study compares a comprehensive and robust range of clinical, functional, and radiological outcomes in CT-planned CO THA versus CT-planned RO THA. The findings of this study will enable an improved understanding of the differences in CO THA versus RO THA with respect to patient satisfaction, functional outcomes, implant survivorship, cost-effectiveness, and complications.Trial registrationClinicalTrials.gov NCT04095845 . Registered on 19 September 2019.

Project description:BackgroundLarge heterogeneity exists in the clinical manifestation of hip osteoarthritis (OA). It is therefore not surprising that pain and disability in individuals with hip OA and after total hip arthroplasty (THA) cannot be explained by biomedical variables alone. Indeed, also maladaptive pain-related cognitions and emotions can contribute to pain and disability, and can lead to poor treatment outcomes. Traumatic experiences, mental disorders, self-efficacy and social support can influence stress appraisal and strategies to cope with pain, but their influence on pain and disability has not yet been established in individuals with hip OA undergoing THA. This study aims (1) to determine the influence of traumatic experiences and mental disorders on pain processing before and shortly after THA (2) to identify preoperative clinical phenotypes in individuals with hip OA eligible for THA, (3) to identify pre- and early postoperative prognostic factors for outcomes in pain and disability after THA, and (4) to identify postoperative clinical phenotypes in individuals after THA.MethodsThis prospective longitudinal cohort study will investigate 200 individuals undergoing THA for hip OA. Phenotyping variables and candidate prognostic factors include pain-related fear-avoidance behaviour, perceived injustice, mental disorders, traumatic experiences, self-efficacy, and social support. Peripheral and central pain mechanisms will be assessed with thermal quantitative sensory testing. The primary outcome measure is the hip disability and osteoarthritis outcome score. Other outcome measures include performance-based measures, hip muscle strength, the patient-specific functional scale, pain intensity, global perceived effect, and outcome satisfaction. All these measurements will be performed before surgery, as well as 6 weeks, 3 months, and 12 months after surgery. Pain-related cognitions and emotions will additionally be assessed in the early postoperative phase, on the first, third, fifth, and seventh day after THA. Main statistical methods that will be used to answer the respective research questions include: LASSO regression, decision tree learning, gradient boosting algorithms, and recurrent neural networks.DiscussionThe identification of clinical phenotypes and prognostic factors for outcomes in pain and disability will be a first step towards pre- and postoperative precision medicine for individuals with hip OA undergoing THA.Trial registrationClinicalTrials.gov: NCT05265858. Registered on 04/03/2022.

Project description:Background: Home-based rehabilitation exercise following Total Hip Arthroplasty (THA) shows similar outcomes compared to supervised outpatient rehabilitation exercise. Little is known about patients' experiences with home-based rehabilitation, and this study aimed to investigate how patients perceived home-based rehabilitation exercise and general physical activity after THA, focusing on facilitators and barriers. Methods: Semi-structured interviews of qualitative design were conducted with 22 patients who had undergone THA and who had performed home-based rehabilitation exercise. The study took place in a regional hospital in Denmark between January 2018 and May 2019. Data were analyzed using an interpretive thematic analysis approach, with theoretical underpinning from the concept 'conduct of everyday life'. The study is embedded within the Pragmatic Home-Based Exercise Therapy after Total Hip Arthroplasty-Silkeborg trial (PHETHAS-1). Results: The main theme, 'wishing to return to the well-known everyday life', and four subthemes were identified. Generally, participants found the home-based rehabilitation exercise boring but were motivated by the goal of returning to their well-known everyday life and performing their usual general physical activities, though some lacked contact to physiotherapist. Participants enrolled in the PHETHAS-1 study used the enrollment as part of their motivation for doing the exercises. Both pain and the absence of pain were identified as barriers for doing home-based rehabilitation exercise. Pain could cause insecurity about possible medical complications, while the absence of pain could lead to the rehabilitation exercise being perceived as pointless. Conclusions: The overall goal of returning to the well-known everyday life served as a facilitator for undertaking home-based rehabilitation exercise after THA along with the flexibility regarding time and place for performing exercises. Boring exercises as well as both pain and no pain were identified as barriers to the performance of home-based rehabilitation exercise. Participants were motivated towards performing general physical activities which were part of their everyday life.

Project description:BackgroundTotal 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/designThis 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.DiscussionThe 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 registrationClinicalTrials.gov NCT04061993 . Registered on 07 November 2019. Protocol ID: PRT_PhD. Version 1.

Dataset Information

Pragmatic Home-Based Exercise after Total Hip Arthroplasty - Silkeborg: Protocol for a prospective cohort study (PHETHAS-1).

Publications

Pragmatic Home-Based Exercise after Total Hip Arthroplasty - Silkeborg: Protocol for a prospective cohort study (PHETHAS-1).

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