PO.PR01.04 · 预防研究
BEFIT运动干预初步研究的中期结果：评估肺癌高危队列的微生物组和免疫功能
Interim results of the BEFIT exercise intervention pilot study to assess the microbiome and immune function in a high-risk cohort for lung cancer
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摘要 Abstract
中文摘要
背景/目的：饮食和运动等可改变的生活方式危险因素已被证明与肺癌风险降低相关。我们最近启动了一项随机对照初步试验，即BEFIT运动干预研究，其总体目标是：a）确认在高危吸烟者中开展运动干预的可行性，b）评估干预对微生物组和炎症生物标志物的影响。本报告将描述该正在进行研究的中期结果，包括参与者特征、招募挑战和依从性。
方法：来自俄亥俄州立大学肺癌筛查诊所（OSULCSC）和社交媒体的参与者被随机分入两组之一：（a）运动/行为支持干预——一项经ACSM批准的为期12周的虚拟抗阻训练加有氧运动项目，或（b）标准治疗——一种仅提供信息的对照条件（如轻度步行）。入选标准包括：年龄40-80岁、运动<150分钟/周、20包年吸烟史以及可使用计算机/互联网。将在基线和干预完成时评估采血、粪便样本、体力活动测量和行为改变预测因素，并进行1年随访以评估依从性。
结果：个体主要通过OSULCSC和社交媒体广告招募。我们的目标是招募40名参与者（每组20名），但由于脱落，干预组有20名、对照组有16名。退出的常见原因包括太忙、改变主意和不再感兴趣。参与者特征包括平均年龄63岁、64%为女性、89%为白人、52%为当前吸烟者、平均BMI为35（肥胖）以及体脂率39%。干预组在干预后显示出显著更大的体重减轻和瘦肌肉量增加。干预依从性高，近90%的课程被出席，未报告不良事件。生物样本分析和社会认知中介因素目前正在进行中。
讨论：我们成功地为高危肺癌的长期吸烟者启动了BEFIT运动干预研究，依从性高且未报告不良事件。尽管存在招募挑战和脱落，我们仍成功招募并实施了干预，干预后体重减轻和瘦肌肉量显著改善。我们将继续分析生物样本数据以评估肠道微生物组和炎症的变化，并期待在完成后报告这些结果。
查看英文原文 English abstract
Background/Objective: Modifiable lifestyle risk factors, such as diet and exercise, have shown to be associated with reduced lung cancer risk. We recently launched a randomized controlled pilot trial, the BEFIT exercise intervention study, whose overall objectives are to: a) confirm the feasibility of an exercise intervention in high-risk smokers, and b) assess the intervention impact on the microbiome and inflammatory biomarkers . This report will describe interim study results, including participant characteristics, recruitment challenges and adherence in this ongoing study.
Methods: Participants from The Ohio State University Lung Cancer Screening Clinic (OSULCSC) and social media were randomized into one of two arms: (a) Exercise/Behavioral Support Intervention - an ACSM-approved 12-week virtual resistance training plus aerobic program, or (b) Standard of Care - an information-only, control condition (e.g. light walking). Eligibility criteria included: ages 40-80 years, exercise<150 minutes/week, 20 pack-year smoking history and computer/internet access. Blood draws, stool samples, physical activity measures and behavior change predictors will be evaluated at baseline and intervention completion, with 1-year follow-up to assess adherence.
Results: Individuals were primarily recruited through the OSULCSC and social media ads. Our goal was to recruit 40 participants (20 per arm), but due to dropout we had 20 in the intervention group and 16 in the control group. Common reasons for withdrawal include too busy, changed mind and no longer interested. Participant characteristics include mean age 63 years, 64% female, 89% white, 52% current smokers and mean BMI of 35 (obese) and 39% body fat. The intervention group showed significantly greater weight loss and increased lean muscle mass after the intervention. Adherence to the intervention was high with almost 90% of sessions attended with no adverse events reported. Biospecimen analyses and social cognitive intermediates are currently underway.
Discussion: We successfully launched the BEFIT exercise intervention study for long-time smokers at high risk for lung cancer with high adherence and no adverse events reported. Despite recruiting challenges and dropout, we successfully recruited and conducted the intervention, with significant improvements in weight loss and lean muscle mass after the intervention. We continue to analyze biospecimen data for changes in the gut microbiome and inflammation, and look forward to reporting these when completed.
利益披露 Disclosure
M. Bittoni, None..
Z. Chaplow, None.