- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02895464
Feasibility of Home-based Preoperative Exercise in Older People
Preoperative Home-based Exercise in Older People Before Colorectal Surgery - a Feasibility Study
Descripción general del estudio
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
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Stockholm, Suecia, 11883
- Stockholm South General Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
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
¿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.
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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.
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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.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Recruitment rate
Periodo de tiempo: Six months
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Number of participants included from eligible patients
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Six months
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Exercise compliance
Periodo de tiempo: At the end of the intervention, after 2-4 weeks
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Number of sessions attended out of planned sessions
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At the end of the intervention, after 2-4 weeks
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Acceptability
Periodo de tiempo: At the end of the intervention, after 2-4 weeks
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Patients and instructors satisfaction with the intervention measured with a survey
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At the end of the intervention, after 2-4 weeks
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Adverse events
Periodo de tiempo: During the intervention, after 1-4 weeks
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Musculoskeletal-related events , cardiovascular episodes, falls and health care use
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During the intervention, after 1-4 weeks
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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
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Meters completed, effort estimated
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Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery
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Inspiratory muscle strength
Periodo de tiempo: Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery
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Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery
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Chair-stand 30-sec
Periodo de tiempo: Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery
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Number
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Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery
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Walking speed (hab/max)
Periodo de tiempo: Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery
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10 meters
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Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery
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Postoperative complications
Periodo de tiempo: Within the first 30 days of surgery
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Clavien-Dindo, Delirium, Mortality
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Within the first 30 days of surgery
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Length of stay
Periodo de tiempo: At discharge, 2-4 weeks after baseline
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At discharge, 2-4 weeks after baseline
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Discharge destination
Periodo de tiempo: At discharge, 2-4 weeks after baseline
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Care level after discharge from hospital (Home/Geriatric Clinic/Nursing Home)
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At discharge, 2-4 weeks after baseline
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- LS1311-1462
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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