Physical Activity Levels During Recovery Following Knee Arthroplasty
23 de julio de 2020 actualizado por: 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.
Descripción general del estudio
Estado
Desconocido
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
De observación
Inscripción (Anticipado)
400
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Andrew J Price, DPhil, FRCS
- Número de teléfono: +44 01865 223421
- Correo electrónico: andrew.price@ndorms.ox.ac.uk
Copia de seguridad de contactos de estudio
- Nombre: Scott R Small, MS
- Número de teléfono: +44 01865 223414
- Correo electrónico: scott.small@ndorms.ox.ac.uk
Ubicaciones de estudio
-
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Oxfordshire
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Oxford, Oxfordshire, Reino Unido, OX3 7LD
- Reclutamiento
- Nuffield Orthopaedic Centre, Oxford University Hospitals Trust
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Contacto:
- Gail Lang
- Correo electrónico: gail.lang@ndorms.ox.ac.uk
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Investigador principal:
- Andrew J Price, DPhil, FRCS
-
Sub-Investigador:
- Scott R Small, MS
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Sub-Investigador:
- Karen L Barker, PhD, FCSP
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Sub-Investigador:
- Sara Khalid, DPhil
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
Participants will be patients undergoing primary total or unicompartmental knee arthroplasty for treatment of end-stage osteoarthritis.
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
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.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in physical activity
Periodo de tiempo: 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.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Oxford Knee Score
Periodo de tiempo: Pre-operative (baseline), 6 weeks, 6 months
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A patient reported outcome measure to assess patient benefit [Range 0 to 48, higher scores corresponding to better outcomes].
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Pre-operative (baseline), 6 weeks, 6 months
|
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Change in EQ-5D-5L
Periodo de tiempo: 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.
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Pre-operative (baseline), 6 weeks, 6 months
|
|
Change in University of California, Los Angeles (UCLA) Activity Score
Periodo de tiempo: 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
Periodo de tiempo: 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.
|
Pre-operative (baseline), 6 weeks, 6 months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Scott R Small, MS, University of Oxford
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
31 de enero de 2020
Finalización primaria (Anticipado)
1 de junio de 2021
Finalización del estudio (Anticipado)
1 de octubre de 2021
Fechas de registro del estudio
Enviado por primera vez
22 de enero de 2020
Primero enviado que cumplió con los criterios de control de calidad
22 de enero de 2020
Publicado por primera vez (Actual)
27 de enero de 2020
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
27 de julio de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
23 de julio de 2020
Última verificación
1 de julio de 2020
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- IRAS 260855
- 19/SW/0151 (Otro identificador: NHS Health Research Authority)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
De-identified individual participant data for all primary and secondary outcome measures will be made available.
Marco de tiempo para compartir IPD
Data will be made available within 6 months following study completion.
Criterios de acceso compartido de IPD
Data access requests will be reviewed by the trial steering committee.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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