Physical Activity Levels During Recovery Following Knee Arthroplasty
23 juillet 2020 mis à jour par: University of Oxford
Identifying the Trajectory of Normal Recovery Following Knee Arthroplasty Through Physical Activity Monitoring Via Wrist-Worn Accelerometry
The goal of this study is to utilize physical activity monitoring to determine the trajectory of normal recovery as it relates to a patient's ability to get up and get moving.
From this work, we hope to be able to define the range in patients' physical activity following knee replacement surgery, and thus, give clinicians a tool and the methodology to identify patients whose recovery is not progressing as quickly as expected.
Data from physical activity monitors will allow the research team to identify how active patients are, how vigorous that activity is, and how well that activity correlates with standard and commonly used patient questionnaires.
Aperçu de l'étude
Statut
Inconnue
Les conditions
Intervention / Traitement
Description détaillée
This study is an observational study of the physical activity levels of adults who have been diagnosed with end-stage osteoarthritis of the knee and are undergoing knee replacement surgery at the Nuffield Orthopaedic Centre, Oxford. Data regarding patient activity and functional recovery will be collected using two methods. First, data will be collected through the extraction of three-axis accelerometer data, collected via a wrist-worn (and hip-worn for a subset of patients) physical activity monitor. This data will be collected in three intervals: pre-operatively, immediately postoperatively, and at 6 months postoperatively. Secondly, data will be collected by standard clinical assessment and patient reported outcome measures. These assessments will again take place pre-operatively, at 6 weeks postoperatively, and at 6 months postoperatively. Additional data will be collected through a simple activity diary, which asks the participants to log their monitor wear-time along with the times that they took bicycle rides or extended walks.
The expected duration of patient involvement is up to a total of 8 to 8.5 weeks over the course of up to 7 months. There are no clinical visits within this protocol beyond what is already within normal patient care. Patients will be asked to post their monitor back to the research centre for data collection and data processing twice during the study period.
The aim of this study is to assess the trajectory of recovery in terms of physical activity in the post-operative knee replacement population, and subsequently to define the expected path of early recovery.
Type d'étude
Observationnel
Inscription (Anticipé)
400
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Oxfordshire
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Oxford, Oxfordshire, Royaume-Uni, OX3 7LD
- Recrutement
- Nuffield Orthopaedic Centre, Oxford University Hospitals Trust
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Contact:
- Gail Lang
- E-mail: gail.lang@ndorms.ox.ac.uk
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Chercheur principal:
- Andrew J Price, DPhil, FRCS
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Sous-enquêteur:
- Scott R Small, MS
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Sous-enquêteur:
- Karen L Barker, PhD, FCSP
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Sous-enquêteur:
- Sara Khalid, DPhil
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
Participants will be patients undergoing primary total or unicompartmental knee arthroplasty for treatment of end-stage osteoarthritis.
La description
Inclusion Criteria:
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18 years or above.
- Diagnosed with required late stage osteoarthritis, undergoing knee arthroplasty in the next 3 months.
- In Investigator's opinion, is able and willing to comply with all trial requirements.
Exclusion Criteria:
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
- Participants who are enrolled in another research study involving an investigational product or methodology that could alter physical activity.
- Participants are undergoing a revision arthroplasty surgery on the operative knee
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Knee Arthroplasty Patient
Patients undergoing primary total or unicompartmental knee arthroplasty for treatment of end-stage osteoarthritis.
|
Reconstruction of part or all of the native articulation at the knee joint via implant.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in physical activity
Délai: Physical activity will be evaluated for 7 days at approximately 2 weeks before surgery, for 6 continuous weeks immediately postoperatively and (for a subset of participants) for 7 continuous days at 6 months postoperatively.
|
The primary outcome measure will physical activity, as extracted from analysis of raw accelerometer data from the activity monitor.
Several variables will be extracted from the raw data, including average acceleration vector (Euclidean norm minus one), bouts of physical activity and percentage of active and sedentary time.
|
Physical activity will be evaluated for 7 days at approximately 2 weeks before surgery, for 6 continuous weeks immediately postoperatively and (for a subset of participants) for 7 continuous days at 6 months postoperatively.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Oxford Knee Score
Délai: Pre-operative (baseline), 6 weeks, 6 months
|
A patient reported outcome measure to assess patient benefit [Range 0 to 48, higher scores corresponding to better outcomes].
|
Pre-operative (baseline), 6 weeks, 6 months
|
|
Change in EQ-5D-5L
Délai: Pre-operative (baseline), 6 weeks, 6 months
|
A patient reported outcome measure to assess patient benefit.
As summary index score from 0 to 1 is given, where 0 is the health state equivalent to dead, 1 is a full healthy outcome, and negative indicates a health state worse than dead.
The score is derived from five sections (Mobility, Self-Care, Usual Activities, Pain/Discomfort, Anxiety/Depression) scored 1 to 5, with higher corresponding to better outcomes.
A second visual analogue score for perceived health is reported from 0 to 100 with higher scores indicating better perceived overall health.
|
Pre-operative (baseline), 6 weeks, 6 months
|
|
Change in University of California, Los Angeles (UCLA) Activity Score
Délai: Pre-operative (baseline), 6 weeks, 6 months
|
A self-reported score to assess patient benefit and physical activity.
The score ranges from 1 to 10 where higher scores indicate greater levels of physical activity
|
Pre-operative (baseline), 6 weeks, 6 months
|
|
Change in International Physical Activity Questionnaire Questionnaire - Short Form
Délai: Pre-operative (baseline), 6 weeks, 6 months
|
A self-reported score to assess patient benefit and physical activity.
The score can be reported in one of three categories: Low, Moderate, or High physical activity.
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Pre-operative (baseline), 6 weeks, 6 months
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Scott R Small, MS, University of Oxford
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
31 janvier 2020
Achèvement primaire (Anticipé)
1 juin 2021
Achèvement de l'étude (Anticipé)
1 octobre 2021
Dates d'inscription aux études
Première soumission
22 janvier 2020
Première soumission répondant aux critères de contrôle qualité
22 janvier 2020
Première publication (Réel)
27 janvier 2020
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
27 juillet 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
23 juillet 2020
Dernière vérification
1 juillet 2020
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- IRAS 260855
- 19/SW/0151 (Autre identifiant: NHS Health Research Authority)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
De-identified individual participant data for all primary and secondary outcome measures will be made available.
Délai de partage IPD
Data will be made available within 6 months following study completion.
Critères d'accès au partage IPD
Data access requests will be reviewed by the trial steering committee.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- CIF
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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