Evolution of Fatigue in Patients With Inflammatory Bowel Disease

Evolution of Fatigue in Patients With Inflammatory Bowel Disease

Patrocinadores

Patrocinador principal: Corporacion Parc Tauli

Fuente Corporacion Parc Tauli
Resumen breve

The aim of this study is to evaluate the evolution and possible factors associated with the persistence of fatigue in patients with quiescent IBD and fatigue included in two previous studies.

Descripción detallada

Fatigue is a common symptom in inflammatory bowel disease and persists despite clinical remission. Fatigue in patients with chronic diseases can be objectified by the FACIT-F scale.

Recent publications have tried to assess the prevalence and factors related to fatigue in patients with IBD.

In 2017 one study evaluated the prevalence and predictive factors of fatigue in out-patients with inflammatory bowel disease. Fatigue was associated with depression, low quality of life and female sex. No association was found with micronutrients or levels of interleukins.

As there are no effective treatments for fatigue in IBD, another study, recently published a study evaluating the role of electroacupuncture in 54 patients with quiescent IBD and fatigue, observing that both electroacupuncture and sham acupuncture improved fatigue compared to the control group.

The aim of this study is to evaluate the evolution and possible factors associated with the persistence of fatigue in patients with quiescent IBD and fatigue included in the two previous studies.

Patients with inflammatory bowel disease and fatigue (FACIT-F score < 40) included in these two previous studies who agree to participate will fill in questionnaires to assess fatigue, anxiety, depression and quality of life in inflammatory bowel disease. Moreover, the relationship of other biological factors with IBD-related fatigue will be determined.

Estado general Not yet recruiting
Fecha de inicio January 7, 2020
Fecha de Terminación December 7, 2020
Fecha de finalización primaria December 7, 2020
Tipo de estudio Observational
Resultado primario
Medida Periodo de tiempo
Evaluate the evolution of fatigue in patients with Inflammatory Bowel Disease at 3 years three years
Resultado secundario
Medida Periodo de tiempo
Assess the biological factors associated with the persistence of fatigue three years
Assess the psychological factors associated with the persistence of fatigue three years
Assess the psychological factors associated with the persistence of fatigue three years
Inscripción 202
Condición
Elegibilidad

Método de muestreo: Non-Probability Sample

Criterios:

Inclusion Criteria:

- Patients with inflammatory bowel disease and fatigue (defined as a FACIT-F score <40 points) previously documented in our two previous studies.

- Written informed consent after receiving clear and objective information about the purpose and characteristics of the study.

- Ability to understand the questionnaires.

Exclusion Criteria:

- Associated tumor disease.

- Pregnancy or breastfeeding.

- Anemia (hemoglobin <12g/dl in women and 14g/dl in men)

- Any concomitant illness that may justify the presence of fatigue.

Género: All

Edad mínima: 18 Years

Edad máxima: N/A

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Diana Horta Principal Investigator Parc Tauli Hospital. Sabadell , Barcelona, Spain, 08208
Contacto general

Apellido: Diana Horta

Teléfono: 93 745 84 54

Email: [email protected]

Fecha de verificación

December 2019

Fiesta responsable

Tipo: Principal Investigator

Afiliación del investigador: Corporacion Parc Tauli

Nombre completo del investigador: Diana Horta-Sangenis

Título del investigador: gastroenterologist physician

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Grupo de brazo

Etiqueta: Patients with Inflammatory Bowel Disease and fatigue

Descripción: Patients with Inflammatory Bowel Disease and fatigue that participated in the two studies (1,2).

Datos del paciente No
Información de diseño del estudio

Modelo de observación: Other

Perspectiva de tiempo: Cross-Sectional

Fuente: ClinicalTrials.gov