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ACTIVE NOT RECRUITING
NCT06445192
NA

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

View on ClinicalTrials.gov

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

OTHER

Best Practice

Receive usual care

PROCEDURE

Biospecimen Collection

Undergo collection of blood samples

OTHER

Exercise Counseling

Attend group counseling

OTHER

Exercise Intervention

Receive aerobic and resistance exercise intervention via telehealth

OTHER

Medical Device Usage and Evaluation

Wear Fitbit

OTHER

Physical Performance Testing

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

OTHER

Telemedicine

Receive aerobic and resistance exercise intervention via telehealth

Locations (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States