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Evaluating 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
Sponsor: Ohio State University Comprehensive Cancer Center
Summary
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.
Official title: The BE FIT Study: Feasibility of an Exercise Intervention on Microbiome and Immune Function in a High-Risk Cohort for Lung Cancer
Key Details
Gender
All
Age Range
40 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
65
Start Date
2023-11-03
Completion Date
2026-12-31
Last Updated
2026-02-13
Healthy Volunteers
Yes
Conditions
Interventions
Best Practice
Receive usual care
Biospecimen Collection
Undergo collection of blood samples
Exercise Counseling
Attend group counseling
Exercise Intervention
Receive aerobic and resistance exercise intervention via telehealth
Medical Device Usage and Evaluation
Wear Fitbit
Physical Performance Testing
Ancillary studies
Questionnaire Administration
Ancillary studies
Telemedicine
Receive aerobic and resistance exercise intervention via telehealth
Locations (1)
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States