- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03864835
NASH-FITTER: Nonalcoholic Steatohepatitis Fitness Intervention Treatment Targeting Endothelial Dysfunction Reversal (NASH-FITTER)
This research is being done to find out if aerobic exercise is beneficial in reversing scarring. Physical activity has been shown to increase fitness in healthy individuals as well as in those with NASH. This research will allow for better understanding the effects of physical activity on fitness and endothelial function in patients with NASH with the goal of reversing scarring.
Approximately 12 people will take part in this research study at Penn State (PSU) Milton S. Hershey Medical Center (HMC), Penn State Physical Medicine & Research (PM&R) Laboratories housed at the Hershey Center for Applied Research (HCAR) and the Penn State University Fitness Center (UFC).
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria
•Enrollment and completion of IRB study # 00011797
Exclusion Criteria
- Inability to provide informed consent
- Institutionalized/prisoner
- Non-English-speaking patients due to unavailability of translators for all visits/sessions
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Moderate intensity aerobic exercise
All subjects will undergo DXA and CRF measurement (relative VO2max) under the supervision of an American College of Sports Medicine (ACSM)-certified fitness professional and study physician at the Penn State PM&R Research Laboratories.
Subjects selected for the interventional pilot trial will receive a FitBit Charge2 HR and be instructed on how to use a FitBit Hear Rate monitor, Fitbit application, Fitbit website, and Fitabase (secure data management platform utilized by >400 clinical trials).
Participants will record their daily food and beverage intake through the Fitbit app.
Individualized feedback will be provided by a registered dietician (RD).
Subjects that meet requirements for the exercise arm (12 total) will be required to exercise 30 minutes, five days per week at a moderate intensity (HR target corresponding to 45-55% of their relative VO2max).
Each session will be supervised in-person at the Penn State University Fitness Center with an ACSM certified exercise physiologist.
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Subjects that meet requirements for the exercise arm (12 total) will be required to exercise 30 minutes, five days per week at a moderate intensity (HR target corresponding to 45-55% of their relative VO2max).
Each session will be supervised in-person at the Penn State University Fitness Center with an ACSM certified exercise physiologist.
This is feasible as Zhang et al.(87) found 66 out of 70 subjects (95%) completed the twelve-month supervised in-person moderate-intensity exercise protocol five-days a week.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
hepatic fibrosis stage using METAVIR score
Periodo de tiempo: 12 months
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The primary endpoint of this study is change in hepatic fibrosis stage.
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12 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
fibrosis change and gains in cardiorespiratory fitness
Periodo de tiempo: 12 months
|
correlation between fibrosis change and gains in CRF
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12 months
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flow mediated dilation
Periodo de tiempo: 12 months
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correlation between fibrosis change and improvements in FMD
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12 months
|
NAFLD Activity Score (NAS)
Periodo de tiempo: 12 months
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The diagnosis of nonalcoholic steatohepatitis (NASH) is defined by the presence and pattern of specific histological abnormalities on liver biopsy.
A separate system of scoring the features of nonalcoholic fatty liver disease (NA) called the NAFLD Activity Score (NAS) was developed as a tool to measure changes in NAFLD.
The grading or NAFLD activity score (NAS) encompasses steatosis, lobular inflammation and ballooning.
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12 months
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intra-hepatic fat content
Periodo de tiempo: 12 months
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changes in intra-hepatic fat content
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12 months
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health related quality of life (HRQOL)
Periodo de tiempo: 12 months
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PROMIS is a computer adaptive test (CATs) used to assess health related quality of life.
The survey contains profiles that measure multiple concepts through a fixed collection of short forms.
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12 months
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Body composition
Periodo de tiempo: 12 months
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body composition change
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12 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jonathan G Stine, MD, Milton S. Hershey Medical Center
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Anticipado)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- STUDY00012210
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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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