Efficacy of Resistance Training as an Aid To Smoking Cessation Treatment

描述（由申请人提供）：为了减少吸烟导致的广泛死亡和疾病，患病率必须加速下降。帮助戒烟的处方药可能是有效的，但高达80%的吸烟者在没有医疗帮助的情况下试图戒烟。美国卫生与公众服务部提倡锻炼作为戒烟的辅助手段，然而，我们对锻炼如何有帮助的理解存在重大差距。到目前为止，有氧运动一直是唯一类型的运动调查，有一个贫穷的了解的机制的行动，有一个代表性不足的男性吸烟者在文献中。这项试验旨在产生新的数据，以解决这些差距。我们的初步研究[R 03 CA 132475]的积极结果表明，阻力训练（即，重量训练）可以为吸烟者提供戒烟的独特行为策略。与对照组相比，经过阻力训练的参与者更有可能实现戒烟，并且在试验结束时体重和体脂更低。这是一个关键的益处，因为通常在戒烟期间和之后发生的体重/脂肪增加抵消了戒烟的益处，从而显著增加了2型糖尿病、高血压和高血压的风险。 肺功能下降本研究的目的是在第一个全面的随机对照试验中测试阻力训练作为戒烟辅助手段的有效性。共有206名男性和女性吸烟者将接受简短的戒烟咨询，然后随机分为12周的阻力训练组或接触控制组。在为期12周的项目期间，两组将每周在现场会面两次，并在12周（3个月）结束时以及6个月和12个月的时间点进行随访评估。在随访期间，参与者将不会接受任何额外的戒烟治疗;但是，阻力训练组将获得健身中心9个月的会员资格，以鼓励继续进行阻力训练作为维持戒烟的一种方式，并将跟踪中心的出勤率。接触控制组的参与者在12个月的随访后还将获得9个月的健身中心会员资格。主要结局是在3个月评估以及6个月和12个月随访时唾液可替宁验证的7天点患病率戒断（PPA）。次要结果将包括对（a）潜在作用机制（例如，皮质醇、情绪、渴望、禁欲自我效能、睡眠的急性变化）;（B）疾病风险的生物标记物的治疗差异（例如，肺功能、HbA 1c、血脂、身体成分、骨量、血压）、体能和每次随访时的运动行为;以及（c）这些变量中的每一个与吸烟结果之间的关联。最后，我们将探讨性别是否会调节治疗对吸烟结果或任何其他因变量（例如，作用机制、生物标志物、健身、锻炼行为）。

DESCRIPTION (provided by applicant): To reduce the widespread death and disease that results from cigarette smoking, declines in prevalence must accelerate. Prescription medications to aid quitting can be effective, but up to 80% of smokers who attempt to quit do so without medical assistance. The U.S. Department of Health and Human Services promotes exercise as an aid for quitting, however, there are significant gaps in our understanding of how exercise is helpful. To date, aerobic exercise has been the only type of exercise investigated; there is a poor understanding of the mechanisms of action; and there is an under-representation of male smokers in the literature. This trial is designed to produce new data that will address each of these gaps. Positive results from our pilot study [R03 CA132475] suggest that resistance training (i.e., weight training) can offer smokers a unique behavioral strategy for quitting. When compared to a control, resistance trained participants were more likely to achieve smoking abstinence and have lower body weight and body fat at the end of the trial. This is a key benefit, as the body weight/fat gain that typically occurs during and after quitting offsets th benefit of cessation with significant increases in the risks for type 2 diabetes, hypertension, and a decline in lung function. The purpose of this study is to test of the efficacy of resistance training as an aid to smoking cessation in the first full scale randomized controlled trial. A tota of 206 male and female smokers will receive a brief smoking cessation counseling session prior to being randomized into a 12-week Resistance Training or Contact Control group. Both groups will meet on-site twice per week during the 12-week program, and follow-up assessments will occur at the end of the 12-weeks (3-month) and at a 6-month and 12-month time point. Participants will not receive any additional smoking cessation treatment during follow-up; however, the Resistance Training group will receive a 9-month membership to a fitness center to encourage continued resistance training as a way to maintain cessation, and attendance to the center will be tracked. Participants in the Contact Control group will also receive a 9-month fitness center membership after their 12-month follow-up. The primary outcome is salivary cotinine verified 7-Day Point Prevalence Abstinence (PPA) at the 3-month assessment, and at the 6 and 12-month follow-ups. Secondary outcomes will include an examination of (a) the potential mechanisms of action (e.g., acute changes in cortisol, mood, cravings, abstinence self-efficacy, sleep) assessed during the 12-week intervention; (b) treatment differences on biological markers of disease risk (e.g., lung function, HbA1c, blood lipids, body composition, bone mass, blood pressure), physical fitness, and exercise behavior at each follow-up; and (c) the association between each of these variables and smoking outcomes. Finally, we will explore whether gender moderates the effect of treatment on smoking outcome, or on any of the other dependent variables (e.g., mechanisms of action, biological markers, fitness, exercise behavior).