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Understanding Pre-operative Activity Levels in Elderly Patients

8 de noviembre de 2018 actualizado por: Joanne Outtrim

Preoperative Use of Wrist-worn Accelerometers to Measure Physical Activity in High-risk Elderly Patients

The investigators aim to determine whether a wrist-worn accelerometer device is able to objectively measure physical activity, and whether it is an acceptable process for high-risk elderly patients prior to planned surgery. Accelerometers measure physical activity in 'counts' of activity, enabling them to record the total amount of activity in a given time period (e.g. number of steps per day), and also the time spent in various levels of intensity of activity. The investigators will ask study participants to wear an accelerometer around their wrist (like a wristwatch) for up to 14 days prior to their surgery. Participants will receive the same care as non-participants. Part of this routine medical care includes a preoperative review by a multidisciplinary team including specific personalised advice to optimise physical activity before surgery. The investigators will measure the impact that this existing intervention has on physical activity levels. Being more physically active is good for our health, and may be associated with a better recovery from surgery. In the future there may be methods of improving physical activity in the period of time before patients' surgery, which may improve their recovery from surgery.

In order to study this further, the investigators first need a robust and objective way of measuring physical activity. In current practice patients are asked to estimate how physically active they are on a day-to-day basis. This relies on how well they remember, and how good they are at getting it right and may not be accurate. The wrist-worn accelerometer is an objective method of measuring physical activity in patients, which not only offers greater understanding of the physical activity levels of elderly patients before a variety of operations, but also offers the opportunity to measure the impact of existing and potential future interventions to modify physical activity in the preoperative period.

Descripción general del estudio

Estado

Desconocido

Tipo de estudio

De observación

Inscripción (Anticipado)

50

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.

Ubicaciones de estudio

    • Cambs
      • Cambridge, Cambs, Reino Unido, CB20QQ
        • Reclutamiento
        • Cambridge University Hospitals NHS Foundation Trust
        • Contacto:
          • Ari Ercole, PhD
          • Número de teléfono: 01223 217889

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

65 años y mayores (Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

The investigators are aiming to recruit approximately 50 high-risk patients aged 65 years and above, prior to major or complex elective surgery.

"High-risk" is determined by Rockwood Clinical Frailty Score ≥4. Major or complex surgery is defined in NICE guideline (NG45).

Descripción

Inclusion Criteria:

  • Male or female aged 65 years or above
  • Rockwood frailty score of ≥4
  • Listed for elective major or complex surgery at Cambridge University Hospitals NHS Foundation Trust
  • Capacity to consent and complete activity questionnaires
  • Willing and able to wear accelerometer around wrist

Exclusion Criteria:

  • Does not meet the inclusion criteria
  • Participant refusal
  • PRIME clinic appointment scheduled less than 72hrs after the nurse led pre-assessment clinic

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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Measuring physical activity, defined as daily average activity-related acceleration (expressed in relative gravity, milligravity) in high risk elderly patients in the preoperative period using wrist worn accelerometers.
Periodo de tiempo: 2 weeks
This will be measured using a wrist worn accelerometer device to measure daily average activity-related acceleration expressed in relative gravity, milligravity.
2 weeks

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Objective measurement of baseline physical activity levels using a wrist worn triaxial accelerometer, across different surgical specialties, thereby obtaining data on the variation in physical activity, expressed in relative gravity (milligravity).
Periodo de tiempo: 2 weeks
Measurement of baseline physical activity levels using a wrist worn triaxial accelerometer, across different surgical specialties, thereby obtaining data on the variation in physical activity, expressed in relative gravity (milligravity).
2 weeks
Measure total daily physical activity, expressed in relative gravity (milligravity), using a wrist-worn triaxial accelerometer, before and after current preoperative intervention occuring as part of routine medical care.
Periodo de tiempo: 2 weeks
Measure total daily physical activity, expressed in relative gravity (milligravity), using a wrist-worn triaxial accelerometer,for one week before and one week after current preoperative intervention occurring as part of routine medical care. This will measure any change in physical activity from baseline to one week post intervention (therefore measured over a total time period of 2 weeks) as part of routine medical care
2 weeks
Correlation between objectively measured physical activity and patient reported physical activity
Periodo de tiempo: 2 weeks
To determine any correlation between measured physical activity (expressed in relative gravity, milligravity), and patient reported physical activity (expressed using the PASE score) measured using appropriate correlation statistics
2 weeks
Subjective measurement of baseline physical activity levels using validated self-reported physical activity questionnaire, across different surgical specialties.
Periodo de tiempo: 2 weeks
Subjective measurement of baseline physical activity levels using validated self-reported physical activity questionnaire, across different surgical specialties, thereby obtaining data on the variation in physical activity measured by the Physical Activity Scale for the Elderly (PASE) score. PASE comprises measures of self-reported occupational, household, and leisure activities during a one-week period. Scores range from 0 to 400 with a higher score indicating a higher level of physical activity
2 weeks
Determine participant compliance in wearing the accelerometer device
Periodo de tiempo: 2 weeks
This will be measured by recording the total wear time (in hours) of the device during the study period
2 weeks

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Colaboradores

Investigadores

  • Investigador principal: Ari Ercole, Cambridge University Hospitals NHS Foundation Trust

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

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)

1 de julio de 2018

Finalización primaria (Anticipado)

30 de junio de 2019

Finalización del estudio (Anticipado)

30 de junio de 2019

Fechas de registro del estudio

Enviado por primera vez

8 de mayo de 2018

Primero enviado que cumplió con los criterios de control de calidad

8 de noviembre de 2018

Publicado por primera vez (Actual)

13 de noviembre de 2018

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

13 de noviembre de 2018

Última actualización enviada que cumplió con los criterios de control de calidad

8 de noviembre de 2018

Última verificación

1 de noviembre de 2018

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • A094782
  • 238840 (Otro identificador: IRAS Number)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

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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