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Feasibility of Home-based Preoperative Exercise in Older People

7 de agosto de 2018 actualizado por: Elisabeth Rydwik, Karolinska Institutet

Preoperative Home-based Exercise in Older People Before Colorectal Surgery - a Feasibility Study

The purpose of the study is to evaluate the feasibility of recruitment procedure, intervention including compliance and the collaboration between in- and out patient clinics of preoperative home-based exercise in older people before colorectal surgery.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

The feasibility study will be conducted in order to evaluate the study design of a future RCT. Feasibility data will eg. consist of study flow description, number of eligible participants, included participants, patients and instructors satisfaction with the intervention, training compliance, reasons for drop-outs, and adverse events.

Patients waiting for colorectal surgery will be recruited and included after informed consent. Physical and respiratory function will be assessed at the hospital before the intervention, the day before surgery and the day before discharge. Data on postoperative complications, length of stay and mortality will be collected during the hospital stay. At baseline and six months after surgery, the participants will receive three questionnaires about level of independence in daily living, physical activity and health related quality of life. The intervention will be performed in the older person's home and consists of a combination of high-intensity respiratory training and individually adjusted functional exercise. Both groups will receive physical activity advice and malnutrition will be screened to optimize their nutritional status.

Tipo de estudio

Intervencionista

Inscripción (Actual)

21

Fase

  • No aplica

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

      • Stockholm, Suecia, 11883
        • Stockholm South General Hospital

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

70 años y mayores (Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Age above 70, understand and speaks the Swedish language. Surgery due to cancer

Exclusion Criteria:

  • Health status that contradicts participation in the study such as unstable heart disease or severe orthopaedic conditions that prohibits training and severe systematic illness.

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

  • Propósito principal: Otro
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Exercise group
The sessions will be led by a physiotherapist, in the older person's home. The sessions will consist of inspiratory muscle training with a resistance starting from 50% of their maximal capacity (30 breathes, 2 times/day). The training session will also consist of high-intensity individually adjusted functional strength and endurance training: chair-stand; stair climb/step up with weight belts, interval walking indoor and/or outdoor. This will be combined with functional task-exercises. The training will be conducted 2-3 times week, for at least two weeks or until they undergo surgery. During the remaining days, the participants will be instructed to follow the recommendation of 30 minutes of moderate physical activity per day, as well as to perform inspiratory muscle training.
The sessions will be led by a physiotherapist, in the older person's home. The sessions will consist of inspiratory muscle training with a resistance starting from 50% of their maximal capacity (30 breathes, 2 times/day). The training session will also consist of high-intensity individually adjusted functional strength and endurance training: chair-stand; stair climb/step up with weight belts, interval walking indoor and/or outdoor. This will be combined with functional task-exercises. The training will be conducted 2-3 times week, for at least two weeks or until they undergo surgery. During the remaining days, the participants will be instructed to follow the recommendation of 30 minutes of moderate physical activity per day, as well as to perform inspiratory muscle training.
Otro: Control group
The participants will receive ordinary preoperative information, but will also be encouraged to follow the recommendation of 150 minutes/week of moderate physical activity.
The sessions will be led by a physiotherapist, in the older person's home. The sessions will consist of inspiratory muscle training with a resistance starting from 50% of their maximal capacity (30 breathes, 2 times/day). The training session will also consist of high-intensity individually adjusted functional strength and endurance training: chair-stand; stair climb/step up with weight belts, interval walking indoor and/or outdoor. This will be combined with functional task-exercises. The training will be conducted 2-3 times week, for at least two weeks or until they undergo surgery. During the remaining days, the participants will be instructed to follow the recommendation of 30 minutes of moderate physical activity per day, as well as to perform inspiratory muscle training.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Recruitment rate
Periodo de tiempo: Six months
Number of participants included from eligible patients
Six months
Exercise compliance
Periodo de tiempo: At the end of the intervention, after 2-4 weeks
Number of sessions attended out of planned sessions
At the end of the intervention, after 2-4 weeks
Acceptability
Periodo de tiempo: At the end of the intervention, after 2-4 weeks
Patients and instructors satisfaction with the intervention measured with a survey
At the end of the intervention, after 2-4 weeks
Adverse events
Periodo de tiempo: During the intervention, after 1-4 weeks
Musculoskeletal-related events , cardiovascular episodes, falls and health care use
During the intervention, after 1-4 weeks

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Six-minute walk
Periodo de tiempo: Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery
Meters completed, effort estimated
Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery
Inspiratory muscle strength
Periodo de tiempo: Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery
Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery
Chair-stand 30-sec
Periodo de tiempo: Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery
Number
Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery
Walking speed (hab/max)
Periodo de tiempo: Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery
10 meters
Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery
Postoperative complications
Periodo de tiempo: Within the first 30 days of surgery
Clavien-Dindo, Delirium, Mortality
Within the first 30 days of surgery
Length of stay
Periodo de tiempo: At discharge, 2-4 weeks after baseline
At discharge, 2-4 weeks after baseline
Discharge destination
Periodo de tiempo: At discharge, 2-4 weeks after baseline
Care level after discharge from hospital (Home/Geriatric Clinic/Nursing Home)
At discharge, 2-4 weeks after baseline

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este 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 septiembre de 2016

Finalización primaria (Actual)

30 de junio de 2018

Finalización del estudio (Actual)

30 de junio de 2018

Fechas de registro del estudio

Enviado por primera vez

9 de agosto de 2016

Primero enviado que cumplió con los criterios de control de calidad

5 de septiembre de 2016

Publicado por primera vez (Estimar)

9 de septiembre de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

8 de agosto de 2018

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

7 de agosto de 2018

Última verificación

1 de agosto de 2018

Más información

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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