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オハイオ州立大学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
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.
The BE FIT Study: Feasibility of an Exercise Intervention on Microbiome and Immune Function in a High-Risk Cohort for Lung Cancer
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的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. | 生体試料採取 Undergo collection of blood samples 運動カウンセリング Attend group counseling 運動介入 Receive aerobic and resistance exercise intervention via telehealth 医療機器の使用と評価 Wear Fitbit 身体能力検査 Ancillary studies アンケート管理 Ancillary studies 遠隔医療 Receive aerobic and resistance exercise intervention via telehealth |
実薬対照薬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. | 最良の実践 Receive usual care 生体試料採取 Undergo collection of blood samples 医療機器の使用と評価 Wear Fitbit 身体能力検査 Ancillary studies アンケート管理 Ancillary studies |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Number of patients recruited to virtually-delivered exercise intervention (feasibility) | 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) | Up to 1 year |
Proportion of patients who achieve study adherence (feasibility) based on attendance to the exercise program sessions and biospecimens submitted. | Study adherence is defined as a) the proportion of patients attending at least 20 out of 24 sessions for the 12-week program and b) the percentage of biospecimen samples collected at the post program period (12 weeks). This study will be considered feasible if the compliance rate for both of these combined is 75% or more. Descriptive statistics will be used to examine the distribution of all patient and treatment characteristics, including compliance. | During 12-week program |
Assess the number of participants with a change in inflammatory biomarkers | Will assess the effect of the intervention on inflammatory markers of C-reactive protein and IL-6 separately using linear mixed models with the biomarker serving as the outcome variable. Will also assess the changes in the biomarkers across time in each intervention group. | Baseline to post-intervention (12 weeks) |
Microbe relative abundances | Will assess the effect of the intervention on the diversity and relative abundances of individual microbes. Will compare everyone's post-intervention time point to baseline in control and the exercise interventions cohorts, applying linear or generalized mixed-effects models for the diversity or individual microbes. | Baseline to post-intervention (12 weeks) |
- 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
- Person undergoing treatment for cancer in any form
- Person plans to enter smoking cessation or change status
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