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Prueba piloto de rehabilitación del núcleo abdominal para mejorar los resultados después de la reparación de una hernia ventral (ABVENTURE-P)

7 de mayo de 2026 actualizado por: Ajit Chaudhari, Ohio State University
Este estudio tiene como objetivo evaluar el papel potencial de la fisioterapia para mejorar los resultados después de la reparación de una hernia ventral.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Después de ser informados sobre el estudio y los riesgos potenciales, todos los pacientes que den su consentimiento informado por escrito realizarán evaluaciones de varias actividades de la vida diaria y completarán varias encuestas que detallan sus habilidades prequirúrgicas, calidad de vida y dolor. Inmediatamente después de su procedimiento quirúrgico, los pacientes serán aleatorizados de manera simple ciego (investigador) en una proporción de 1:1 a fisioterapia supervisada (8 semanas, dos veces por semana) o precauciones posquirúrgicas estándar. El investigador cegado repetirá las evaluaciones y encuestas a los 30 días, 10 semanas, 6 meses y 1 año después de la cirugía.

Tipo de estudio

Intervencionista

Inscripción (Actual)

138

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

  • Estados Unidos
    • Ohio
      • Columbus, Ohio, Estados Unidos, 43210
        • Ohio State University Wexner Medical Center

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

Descripción

Criterios de inclusión

  • Mayores de 18 años
  • Diagnóstico de hernia ventral
  • Programado para reparación electiva de hernia ventral
  • Estado funcional independiente
  • Ancho de hernia transversal de 2 cm o más

Criterio de exclusión

  • Trastorno del movimiento o del equilibrio previamente diagnosticado
  • Uso de dispositivo de asistencia ambulatorio (andador o bastón)
  • Actualmente no está recibiendo o planea someterse a fisioterapia u otra intervención de ejercicio especializado supervisada por un profesional de rehabilitación médica

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: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Instrucciones posoperatorias estándar
A los participantes del grupo de control se les indicará en el momento del alta posoperatoria que deben seguir las instrucciones posoperatorias.
Otro: Precauciones postoperatorias
Esta intervención incluye instrucciones posoperatorias estándar de atención que se suelen dar a los pacientes que se someten a una reparación de hernia ventral en todo el mundo. Estos incluyen limitar la actividad física extenuante y una restricción de levantamiento de no más de 10 libras durante 6 semanas. También se recomienda el uso de carpetas durante 4 a 6 semanas después de la operación.
Experimental: Fisioterapia Supervisada
A los participantes del grupo de fisioterapia se les programarán visitas a la clínica de fisioterapia a partir de dos semanas después de la cirugía, y se someterán a tratamientos de fisioterapia supervisados ​​aproximadamente dos veces por semana durante ocho semanas de acuerdo con una rehabilitación postoperatoria de cirugía abdominal central estandarizada basada en evidencia. programa.
Otro: Fisioterapia Supervisada
El curso de fisioterapia supervisada de 8 semanas dos veces por semana comienza 2 semanas después de la cirugía. Se enfoca en la función del núcleo abdominal a través del reentrenamiento y fortalecimiento progresivo de los músculos, y la educación sobre la mecánica corporal y la postura específica del paciente.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change From Baseline in Five Times Sit-to-stand Time
Periodo de tiempo: Baseline before surgery, 10 weeks after surgery
From a standard chair, stand and sit back down five times in immediate succession as quickly as possible. The test is scored in seconds, where a shorter time represents greater mobility.
Baseline before surgery, 10 weeks after surgery
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function
Periodo de tiempo: Baseline before surgery, 10 weeks after surgery
PROMIS-Physical Function is a computer-adaptive patient-reported questionnaire asking questions about physical function. The responses are converted to a t-score which is then reported as a percentile, where 50th percentile represents the average individual. Higher scores indicate greater physical function. This outcome is reported as a change in percentile, where a change of 0 indicates no change in physical function between the two timepoints and a positive change in percentile points indicates an improvement in physical function relative to the rest of the population.
Baseline before surgery, 10 weeks after surgery
Change From Baseline in Quiet Unstable Sitting Test
Periodo de tiempo: Baseline before surgery, 10 weeks after surgery
Sit on an inflated cushion that creates an unstable surface for 60 seconds with eyes closed and arms crossed while counting to a metronome. The raw measurement is the center of pressure excursion (cumulative amount of postural sway) of the participant during the 60 seconds. QUeST is scored as a scaled Z-score, where 0 represents the mean value for a healthy control population. A negative score indicates how many multiples of the standard error of measurement the participant is worse than the mean value for a healthy normal population. A positive change indicates improvement in core stability, with an MCID for change ≥1. The total range of the measure can be as high as 0 and has no explicit negative bound.
Baseline before surgery, 10 weeks after surgery

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Hernia Related Quality of Life Survey From Baseline
Periodo de tiempo: baseline before surgery, 10 weeks after surgery
The Hernia-related Quality of Life Survey (HerQLeS) patient-reported questionnaire asks questions about how abdominal wall function affects activities of daily living, independent mobility, and mental health. The survey is scored on a 0-100 scale, where 100 indicates the highest quality of life and 0 indicates the worst.
baseline before surgery, 10 weeks after surgery
Change in Timed Up-And-Go Time From Baseline
Periodo de tiempo: baseline before surgery, 10 weeks after surgery
Starting seated in a standard chair, stand, walk forward 3 m, turn 180 deg, walk back to chair, sit down. Do all of these as quickly as can be done safely. The test is scored in seconds, and a lower time indicates better mobility.
baseline before surgery, 10 weeks after surgery
Change From Baseline in International Physical Activity Questionnaire - Short Form
Periodo de tiempo: baseline before surgery, 10 weeks after surgery
Self-reported physical activity questions spanning sedentary behavior, job activity, transportation activity, household activity, and recreational activity. The test is scored in Metabolic Equivalent of Task (MET)-minutes per week. More minutes means greater physical activity, either by increasing time or the intensity of the activity or both.
baseline before surgery, 10 weeks after surgery
Change From Baseline in Tampa Scale of Kinesiophobia - Short Form
Periodo de tiempo: baseline before surgery, 10 weeks after surgery
Self-reported 11-question survey on how fear affects desire and ability to perform physical activities. Scores range from 11 (lowest) to 44 (highest). Higher scores indicate greater fear, where 11-22 is minimal fear, 23-28 is low fear, 29-35 is moderate fear, and 36-44 is high fear.
baseline before surgery, 10 weeks after surgery
Number of Participants With Hernia Recurrence Using the Hernia Recurrence Inventory
Periodo de tiempo: 1 year after surgery
Patient-reported questionnaire asking questions regarding a recurrence of the hernia based on pain and presence of a physical bulge. A recurrence is determined by if the patient reports thinking the hernia has come back, feeling or seeing a bulge, or having pain or symptoms at the site. A positive response to any of these 3 questions is considered a recurrence. A recurrence is considered a suboptimal outcome.
1 year after surgery
Change in Hernia Related Quality of Life Survey From Baseline
Periodo de tiempo: baseline before surgery, 1 year after surgery
The Hernia-related Quality of Life Survey (HerQLeS) patient-reported questionnaire asks questions about how abdominal wall function affects activities of daily living, independent mobility, and mental health. The survey is scored on a 0-100 scale, where 100 indicates the highest quality of life and 0 indicates the worst.
baseline before surgery, 1 year after surgery
Change in Timed Up-And-Go Time From Baseline
Periodo de tiempo: baseline before surgery, 1 year after surgery
Starting seated in a standard chair, stand, walk forward 3 m, turn 180 deg, walk back to chair, sit down. Do all of these as quickly as can be done safely. The test is scored in seconds, and a lower time indicates better mobility.
baseline before surgery, 1 year after surgery
Change From Baseline in International Physical Activity Questionnaire - Long Form
Periodo de tiempo: baseline before surgery, 1 year after surgery
Self-reported physical activity questions spanning sedentary behavior, job activity, transportation activity, household activity, and recreational activity. The test is scored in Metabolic Equivalent of Task (MET)-minutes per week. More minutes means greater physical activity, either by increasing time or the intensity of the activity or both.
baseline before surgery, 1 year after surgery
Change From Baseline in Tampa Scale of Kinesiophobia - Short Form
Periodo de tiempo: baseline before surgery, 1 year after surgery
Self-reported 11-question survey on how fear affects desire and ability to perform physical activities. Scores range from 11 (lowest) to 44 (highest). Higher scores indicate greater fear, where 11-22 is minimal fear, 23-28 is low fear, 29-35 is moderate fear, and 36-44 is high fear.
baseline before surgery, 1 year after surgery
Change From Baseline in Five Times Sit-to-stand Time
Periodo de tiempo: baseline before surgery, 1 year after surgery
From a standard chair, stand and sit back down five times in immediate succession as quickly as possible. The test is scored in seconds, where a shorter time represents greater mobility.
baseline before surgery, 1 year after surgery
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function
Periodo de tiempo: baseline before surgery, 1 year after surgery
PROMIS-Physical Function is a computer-adaptive patient-reported questionnaire asking questions about physical function. The responses are converted to a t-score which is then reported as a percentile, where 50th percentile represents the average individual. Higher scores indicate greater physical function. This outcome is reported as a change in percentile, where a change of 0 indicates no change in physical function between the two timepoints and a positive change in percentile points indicates an improvement in physical function relative to the rest of the population.
baseline before surgery, 1 year after surgery
Change From Baseline in Quiet Unstable Sitting Test
Periodo de tiempo: baseline before surgery, 1 year after surgery
Sit on an inflated cushion that creates an unstable surface for 60 seconds with eyes closed and arms crossed while counting to a metronome. The raw measurement is the center of pressure excursion (cumulative amount of postural sway) of the participant during the 60 seconds. QUeST is scored as a scaled Z-score, where 0 represents the mean value for a healthy control population. A negative score indicates how many multiples of the standard error of measurement the participant is worse than the mean value for a healthy normal population. A positive change indicates improvement in core stability, with an MCID for change ≥1. The total range of the measure can be as high as 0 and has no explicit negative bound.
baseline before surgery, 1 year after surgery

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Hernia Related Quality of Life Survey From Baseline
Periodo de tiempo: baseline before surgery, 30 days after surgery
The Hernia-related Quality of Life Survey (HerQLeS) patient-reported questionnaire asks questions about how abdominal wall function affects activities of daily living, independent mobility, and mental health. The survey is scored on a 0-100 scale, where 100 indicates the highest quality of life and 0 indicates the worst.
baseline before surgery, 30 days after surgery
Change in Timed Up-And-Go Time From Baseline
Periodo de tiempo: baseline before surgery, 30 days after surgery
Starting seated in a standard chair, stand, walk forward 3 m, turn 180 deg, walk back to chair, sit down. Do all of these as quickly as can be done safely. The test is scored in seconds, and a lower time indicates better mobility.
baseline before surgery, 30 days after surgery
Change From Baseline in International Physical Activity Questionnaire - Short Form
Periodo de tiempo: baseline before surgery, 30 days after surgery
Self-reported physical activity questions spanning sedentary behavior, job activity, transportation activity, household activity, and recreational activity. The test is scored in Metabolic Equivalent of Task (MET)-minutes per week. More minutes means greater physical activity, either by increasing time or the intensity of the activity or both.
baseline before surgery, 30 days after surgery
Change From Baseline in Tampa Scale of Kinesiophobia - Short Form
Periodo de tiempo: baseline before surgery, 30 days after surgery
Self-reported 11-question survey on how fear affects desire and ability to perform physical activities. Scores range from 11 (lowest) to 44 (highest). Higher scores indicate greater fear, where 11-22 is minimal fear, 23-28 is low fear, 29-35 is moderate fear, and 36-44 is high fear.
baseline before surgery, 30 days after surgery
Change From Baseline in Five Times Sit-to-stand Time
Periodo de tiempo: baseline before surgery, 30 days after surgery
From a standard chair, stand and sit back down five times in immediate succession as quickly as possible. The test is scored in seconds, where a shorter time represents greater mobility.
baseline before surgery, 30 days after surgery
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function
Periodo de tiempo: baseline before surgery, 30 days after surgery
PROMIS-Physical Function is a computer-adaptive patient-reported questionnaire asking questions about physical function. The responses are converted to a t-score which is then reported as a percentile, where 50th percentile represents the average individual. Higher scores indicate greater physical function. This outcome is reported as a change in percentile, where a change of 0 indicates no change in physical function between the two timepoints and a positive change in percentile points indicates an improvement in physical function relative to the rest of the population.
baseline before surgery, 30 days after surgery
Change From Baseline in Quiet Unstable Sitting Test
Periodo de tiempo: baseline before surgery, 30 days after surgery
Sit on an inflated cushion that creates an unstable surface for 60 seconds with eyes closed and arms crossed while counting to a metronome. The raw measurement is the center of pressure excursion (cumulative amount of postural sway) of the participant during the 60 seconds. QUeST is scored as a scaled Z-score, where 0 represents the mean value for a healthy control population. A negative score indicates how many multiples of the standard error of measurement the participant is worse than the mean value for a healthy normal population. A positive change indicates improvement in core stability, with an MCID for change ≥1. The total range of the measure can be as high as 0 and has no explicit negative bound.
baseline before surgery, 30 days after surgery
Change in Hernia Related Quality of Life Survey From Baseline
Periodo de tiempo: baseline before surgery, 6 months after surgery
The Hernia-related Quality of Life Survey (HerQLeS) patient-reported questionnaire asks questions about how abdominal wall function affects activities of daily living, independent mobility, and mental health. The survey is scored on a 0-100 scale, where 100 indicates the highest quality of life and 0 indicates the worst.
baseline before surgery, 6 months after surgery
Change in Timed Up-And-Go Time From Baseline
Periodo de tiempo: baseline before surgery, 6 months after surgery
Starting seated in a standard chair, stand, walk forward 3 m, turn 180 deg, walk back to chair, sit down. Do all of these as quickly as can be done safely. The test is scored in seconds, and a lower time indicates better mobility.
baseline before surgery, 6 months after surgery
Change From Baseline in International Physical Activity Questionnaire - Long Form
Periodo de tiempo: baseline before surgery, 6 months after surgery
Self-reported physical activity questions spanning sedentary behavior, job activity, transportation activity, household activity, and recreational activity. The test is scored in Metabolic Equivalent of Task (MET)-minutes per week. More minutes means greater physical activity, either by increasing time or the intensity of the activity or both.
baseline before surgery, 6 months after surgery
Change From Baseline in Tampa Scale of Kinesiophobia - Short Form
Periodo de tiempo: baseline before surgery, 6 months after surgery
The Hernia-related Quality of Life Survey (HerQLeS) patient-reported questionnaire asks questions about how abdominal wall function affects activities of daily living, independent mobility, and mental health. The survey is scored on a 0-100 scale, where 100 indicates the highest quality of life and 0 indicates the worst.
baseline before surgery, 6 months after surgery
Change From Baseline in Five Times Sit-to-stand Time
Periodo de tiempo: baseline before surgery, 6 months after surgery
From a standard chair, stand and sit back down five times in immediate succession as quickly as possible. The test is scored in seconds, where a shorter time represents greater mobility.
baseline before surgery, 6 months after surgery
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function
Periodo de tiempo: baseline before surgery, 6 months after surgery
PROMIS-Physical Function is a computer-adaptive patient-reported questionnaire asking questions about physical function. The responses are converted to a t-score which is then reported as a percentile, where 50th percentile represents the average individual. Higher scores indicate greater physical function. This outcome is reported as a change in percentile, where a change of 0 indicates no change in physical function between the two timepoints and a positive change in percentile points indicates an improvement in physical function relative to the rest of the population.
baseline before surgery, 6 months after surgery
Change From Baseline in Quiet Unstable Sitting Test
Periodo de tiempo: baseline before surgery, 6 months after surgery
Sit on an inflated cushion that creates an unstable surface for 60 seconds with eyes closed and arms crossed while counting to a metronome. The raw measurement is the center of pressure excursion (cumulative amount of postural sway) of the participant during the 60 seconds. QUeST is scored as a scaled Z-score, where 0 represents the mean value for a healthy control population. A negative score indicates how many multiples of the standard error of measurement the participant is worse than the mean value for a healthy normal population. A positive change indicates improvement in core stability, with an MCID for change ≥1. The total range of the measure can be as high as 0 and has no explicit negative bound.
baseline before surgery, 6 months after surgery

Colaboradores e Investigadores

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

Patrocinador

Ohio State University

Colaboradores

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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)

19 de abril de 2022

Finalización primaria (Actual)

18 de febrero de 2025

Finalización del estudio (Actual)

23 de diciembre de 2025

Fechas de registro del estudio

Enviado por primera vez

3 de noviembre de 2021

Primero enviado que cumplió con los criterios de control de calidad

19 de noviembre de 2021

Publicado por primera vez (Actual)

2 de diciembre de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

3 de junio de 2026

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

7 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 2021H0336
  • R01DK131207 (Subvención/contrato del NIH de EE. UU.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

Solo los datos no identificados se compartirán con otros investigadores.

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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