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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-03

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Lung Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Outcome assessments will be obtained by research staff blinded to treatment group assignment.

Study Groups

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Group 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.

Group Type EXPERIMENTAL

Biospecimen Collection

Intervention Type PROCEDURE

Undergo collection of blood samples

Exercise Counseling

Intervention Type OTHER

Attend group counseling

Exercise Intervention

Intervention Type OTHER

Receive aerobic and resistance exercise intervention via telehealth

Medical Device Usage and Evaluation

Intervention Type OTHER

Wear Fitbit

Physical Performance Testing

Intervention Type OTHER

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Telemedicine

Intervention Type OTHER

Receive aerobic and resistance exercise intervention via telehealth

Group 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.

Group Type ACTIVE_COMPARATOR

Best Practice

Intervention Type OTHER

Receive usual care

Biospecimen Collection

Intervention Type PROCEDURE

Undergo collection of blood samples

Medical Device Usage and Evaluation

Intervention Type OTHER

Wear Fitbit

Physical Performance Testing

Intervention Type OTHER

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Best Practice

Receive usual care

Intervention Type OTHER

Biospecimen Collection

Undergo collection of blood samples

Intervention Type PROCEDURE

Exercise Counseling

Attend group counseling

Intervention Type OTHER

Exercise Intervention

Receive aerobic and resistance exercise intervention via telehealth

Intervention Type OTHER

Medical Device Usage and Evaluation

Wear Fitbit

Intervention Type OTHER

Physical Performance Testing

Ancillary studies

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Telemedicine

Receive aerobic and resistance exercise intervention via telehealth

Intervention Type OTHER

Other Intervention Names

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standard of care standard therapy Biological Sample Collection Biospecimen Collected Specimen Collection Physical Fitness Testing Physical Function Testing Telehealth

Eligibility Criteria

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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