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

The Ohio State University

Status: Enrolling

Conditions: Lung Carcinoma

Treatments: Other: Exercise Counseling; Other: Questionnaire Administration; Other: Exercise Intervention; Other: Medical Device Usage and Evaluation; Other: Best Practice; Other: Physical Performance Testing; Other: Telemedicine; Procedure: Biospecimen Collection

Study type: Interventional

Funder types: Other

Identifiers

NCT06445192

NCI-2023-05556 (Registry Identifier)

OSU-22194

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 88 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Person undergoing treatment for cancer in any form
• Person plans to enter smoking cessation or change status

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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88 participants in 2 patient groups

Group I (exercise intervention)

Experimental group

Description:

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.

Treatment:

Other: Telemedicine

Procedure: Biospecimen Collection

Other: Physical Performance Testing

Other: Medical Device Usage and Evaluation

Other: Exercise Intervention

Other: Questionnaire Administration

Other: Exercise Counseling

Group II (usual care)

Active Comparator group

Description:

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.

Treatment:

Procedure: Biospecimen Collection

Other: Physical Performance Testing

Other: Best Practice

Other: Medical Device Usage and Evaluation

Other: Questionnaire Administration