IA Trial Radar | ||
|---|---|---|
O estudo clínico NCT06445192 para Carcinoma Pulmonar está recrutando. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui. | ||
Um estudo corresponde aos critérios do filtro
Visualização em cartões
Voltar à pesquisa
Universidade Estadual 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
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT06445192 é um ensaio intervencionista para Carcinoma Pulmonar. Seu status atual é: recrutando. O estudo começou em 3 de novembro de 2023 e pretende incluir 88 participantes. Coordenado por a Universidade Estadual de Ohio e deve ser concluído em 31 de dezembro de 2025. Essas informações foram atualizadas no ClinicalTrials.gov em 3 de junho de 2025.
Resumo
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.
Descrição detalhada
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
Condições
Carcinoma PulmonarOutros IDs do estudo
Número NCT
Data de início (real)
2023-11-03
Última atualização postada
2025-06-03
Data de conclusão (estimada)
2025-12-31
Inscrição (estimada)
88
Tipo de estudo
Intervencionista
FASE
N/A
Status
Recrutando
Propósito principal
Prevenção
Alocação do design
Randomizado
Modelo de intervenção
Atribuição paralela
Cegamento (Mascaramento)
Simples-cego
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
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. | Coleta de biospecimen Undergo collection of blood samples Aconselhamento de exercícios Attend group counseling Intervenção de exercício Receive aerobic and resistance exercise intervention via telehealth Uso e avaliação de dispositivo médico Wear Fitbit Teste de desempenho físico Ancillary studies Administração de questionário Ancillary studies Telemedicina Receive aerobic and resistance exercise intervention via telehealth |
Comparador ativoGroup 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. | Melhor prática Receive usual care Coleta de biospecimen Undergo collection of blood samples Uso e avaliação de dispositivo médico Wear Fitbit Teste de desempenho físico Ancillary studies Administração de questionário Ancillary studies |
Desfecho primário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
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) |
Critérios de elegibilidade
Idades elegíveis
Adulto, Adulto mais velho
Idade mínima
40 Years
Sexos elegíveis
Todos
Aceita voluntários saudáveis
Sim
- 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
Universidade Estadual de Ohio455 estudos clínicos ativos para explorarResponsável pelo estudo
Marisa Bittoni, Investigador principal, Principal Investigator, Ohio State University Comprehensive Cancer Center
Contato central do estudo
Contato: The Ohio State Comprehensive Cancer Center, 800-293-5066, [email protected]
1 Locais do estudo em 1 países
Ohio
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, 43210, United States
Marisa Bittoni, PhD, Contato, 614-206-3518, [email protected]
Marisa Bittoni, PhD, Investigador principal
Recrutando