IA Trial Radar | ||
|---|---|---|
El ensayo clínico NCT06445192 para Carcinoma Pulmonar está reclutando. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí. | ||
Un ensayo coincide con los criterios de filtro
Vista de tarjeta
Volver a la búsqueda
Universidad del Estado de OhioEvaluating the Impact of a Virtually Supervised Exercise Intervention and Group Counseling on Inflammation and the Microbiome of Smokers at High Risk for Lung Cancer, BE FIT Trial
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el ensayo' para ver y discutir la información del ensayo en el idioma que haya seleccionado.
El estudio clínico NCT06445192 es un ensayo intervencionista para Carcinoma Pulmonar. Su estado actual es: reclutando. El ensayo se inició el 3 de noviembre de 2023, con el objetivo de reclutar a 88 participantes. Dirigido por la Universidad del Estado de Ohio, se espera que finalice el 31 de diciembre de 2025. Los datos se actualizaron por última vez en ClinicalTrials.gov el 3 de junio de 2025.
Resumen
This phase II trial evaluates how a virtually supervised exercise intervention in combination with group counseling affects inflammation and the bacterial composition (microbiome) of the gut in smokers who are at high risk for lung cancer. Physical exercise has been shown to reduce lung cancer development and to have beneficial effects on the gut microbiome and inflammation. Group counseling may promote adherence to the exercise intervention by empowering participants to exert greater control over their behavior and environment. This clinical trial may help researchers understand how exercise impacts inflammation and the microbiome in people at risk for lung cancer and whether or not exercise with counseling can improve health outcomes in high-risk individuals.
Descripción detallada
PRIMARY OBJECTIVES:
I. To evaluate the feasibility and preliminary efficacy of establishing a multi-component virtually-delivered exercise intervention trial with longitudinal biomarker and microbiome collection in the Ohio State University Lung Cancer Screening Clinic (OSULCSC).
II. To determine the impact of the multi-component virtually-delivered exercise intervention on the microbiome and inflammatory biomarkers.
OUTLINE: Participants are randomized to 1 of 2 groups.
GROUP I: Participants receive the supervised aerobic and resistance exercise intervention over 1 hour via telehealth twice a week (BIW) in weeks 1-8 and once a week (QW) in weeks 9-12 and then continue with unsupervised exercise sessions BIW in weeks 13-52. Participants also attend group counseling sessions over 1 hour QW in weeks 1-8 and bi-weekly in weeks 9-12. Participants also wear a Fitbit throughout the trial and undergo collection of blood samples at baseline and follow up.
GROUP II: Participants receive usual care consisting of education on standard recommendations for physical activity, the benefits of exercise, and an example of a light walking program. Participants also wear a Fitbit throughout the trial and undergo collection of blood samples at baseline and follow up.
After completion of study intervention, participants are followed up at 12 weeks and 1 year.
Título oficial
The BE FIT Study: Feasibility of an Exercise Intervention on Microbiome and Immune Function in a High-Risk Cohort for Lung Cancer
Condiciones médicas
Carcinoma PulmonarOtros ID del ensayo
Número del NCT
Inicio del ensayo (real)
2023-11-03
Última actualización
2025-06-03
Fecha de finalización (estimada)
2025-12-31
Inscripción (prevista)
88
Tipo de estudio
Intervencionista
FASE
N/A
Estado general
Reclutando
Objetivo principal
Prevención
Método de asignación
Aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Simple
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
ExperimentalGroup I (exercise intervention) Participants receive the supervised aerobic and resistance exercise intervention over 1 hour via telehealth BIW in weeks 1-8 and QW in weeks 9-12 and then continue with unsupervised exercise sessions BIW in weeks 13-52. Participants also attend group counseling sessions over 1 hour QW in weeks 1-8 and bi-weekly in weeks 9-12. Participants also wear a Fitbit throughout the trial and undergo collection of blood samples at baseline and follow up. | Recolección de biospecímenes Undergo collection of blood samples Asesoramiento en ejercicio Attend group counseling Intervención de ejercicio Receive aerobic and resistance exercise intervention via telehealth Uso y evaluación de dispositivos médicos Wear Fitbit Pruebas de rendimiento físico Ancillary studies Administración de cuestionarios Ancillary studies Telemedicina Receive aerobic and resistance exercise intervention via telehealth |
Comparador activoGroup II (usual care) Participants receive usual care consisting of education on standard recommendations for physical activity, the benefits of exercise, and an example of a light walking program. Participants also wear a Fitbit throughout the trial and undergo collection of blood samples at baseline and follow up. | Mejor práctica Receive usual care Recolección de biospecímenes Undergo collection of blood samples Uso y evaluación de dispositivos médicos Wear Fitbit Pruebas de rendimiento físico Ancillary studies Administración de cuestionarios Ancillary studies |
Resultado primario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Number of patients recruited to virtually-delivered exercise intervention (feasibility) | To evaluate the feasibility and preliminary efficacy of establishing a multi-component virtually-delivered exercise intervention trial with longitudinal biomarker and microbiome collection in the Ohio State University Lung Cancer Screening Clinic (OSULCSC) | Up to 1 year |
Proportion of patients who achieve study adherence (feasibility) based on attendance to the exercise program sessions and biospecimens submitted. | Study adherence is defined as a) the proportion of patients attending at least 20 out of 24 sessions for the 12-week program and b) the percentage of biospecimen samples collected at the post program period (12 weeks). This study will be considered feasible if the compliance rate for both of these combined is 75% or more. Descriptive statistics will be used to examine the distribution of all patient and treatment characteristics, including compliance. | During 12-week program |
Assess the number of participants with a change in inflammatory biomarkers | Will assess the effect of the intervention on inflammatory markers of C-reactive protein and IL-6 separately using linear mixed models with the biomarker serving as the outcome variable. Will also assess the changes in the biomarkers across time in each intervention group. | Baseline to post-intervention (12 weeks) |
Microbe relative abundances | Will assess the effect of the intervention on the diversity and relative abundances of individual microbes. Will compare everyone's post-intervention time point to baseline in control and the exercise interventions cohorts, applying linear or generalized mixed-effects models for the diversity or individual microbes. | Baseline to post-intervention (12 weeks) |
Criterios de elegibilidad
Criterios de edad
Adulto, Adulto mayor
Edad mínima
40 Years
Criterios de sexo
Todos
Admisión de voluntarios sanos
Sí
- 50-77 years of age
- Current or former smoker with 20-pack year smoking history and within the last 15 years
- Fewer than 150 minutes of participation in moderate intensity physical activity each week
- All participants must be free of severe heart, respiratory (e.g. chronic obstructive pulmonary disease [COPD]), or systemic disease that would make moderate intensity exercise participation unsafe
- Willing to sign an informed consent
- Person undergoing treatment for cancer in any form
- Person plans to enter smoking cessation or change status
Universidad del Estado de Ohio455 ensayos clínicos activos para explorarParte responsable del ensayo
Marisa Bittoni, Investigador principal, Principal Investigator, Ohio State University Comprehensive Cancer Center
Contactos centrales del ensayo
Contacto: The Ohio State Comprehensive Cancer Center, 800-293-5066, [email protected]
1 Sitios del ensayo en 1 países
Ohio
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, 43210, United States
Marisa Bittoni, PhD, Contacto, 614-206-3518, [email protected]
Marisa Bittoni, PhD, Investigador principal
Reclutando