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

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.

Conditions

• Lung Carcinoma

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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center

  lead OTHER

Principal Investigators

• Marisa Bittoni, PhD · Ohio State University Comprehensive Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-11-03

Primary Completion

2026-12-31

Completion

2026-12-31

Countries

• United States

Study Locations