Exercise and Nicotine Replacement for Female Smokers

女性吸烟者的运动和尼古丁替代品

• 批准号: 7274391
• 负责人: TARU KINNUNEN
• 金额: $ 2.78万
• 依托单位: HARVARD MEDICAL SCHOOL
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-04-15 至 2008-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7274391
• 关键词: aerobic exercise; clinical research; cognitive behavior therapy; combination therapy; female; human middle age (35-64); human subject; human therapy evaluation; menstrual cycle; nicotine; nicotine replacement; patient oriented research; radioimmunoassay; smoking; smoking cessation; therapy compliance; tobacco abuse; transdermal drug delivery; women' s health; young adult human (21-34)

DESCRIPTION (provided by applicant): Overcoming tobacco use and nicotine dependence, one of the main cardiovascular risk factors, appears to be more difficult for women than for men, mainly because 1) women may be more sensitive to the effects of nicotine than men; 2) negative affectivity that is associated with continued tobacco use is more common among women than men; and 3) women have more concerns about weight as a reason for continuing smoking and not attempting to quit. The combination of an exercise intervention with nicotine replacement therapy (NRT) should provide a particularly efficacious and cost-effective treatment for female smokers. In our ongoing study, we have found that aerobic exercise, held in a supervised hospital setting, and used as an adjunct to NRT, has produced higher quit rates than standard care with NRT. However, relapse was still very rapid and adherence to the exercise regimen was less than optimal. Exercise adherence was particularly poor among those who had higher body mass index, higher nicotine dependence, and depression prior to quitting, i.e., those with a high cardiovascular risk index. Increasing the adherence to the exercise might result in improved cessation rates, concurrently reducing cardiovascular risk factors and, in turn, female morbidity and mortality. The proposed study will investigate if cognitive-behavioral exercise adherence counseling (CBC) added to an exercise prescription (ERx), used effectively in many patient-populations, increases engagement in physical exercise among female smokers attempting to quit compared to an ERx alone condition. We will examine if increased exercise adherence results in higher cessation rates, and whether prescribed exercise that is home-based (HB), making implementation potentially easier and cost-effective, would result in the same cessation effects as an exercise program that is facility-based (FB). We are planning to include nicotine transdermal patch treatment as the pharmacological treatment and aerobic exercise as a behavioral adjunct. The proposed study will assess how to achieve the maximum effects of aerobic exercise on smoking cessation and the minimum conditions under which these effects can be achieved. Transdermal NRT will be given to 540 female smokers who are randomly assigned to exercise under one of four conditions: HB+ERx, FB+ERx, HB+ERx+CBC, or FB+ERx+CBC. Participants will engage in 3 sessions of aerobic exercise per week from 3 weeks precessation through 12 weeks postcessation, and will be followed for one year postcessation. In addition to assessing how best to implement aerobic exercise as a smoking cessation adjunct, the mechanisms by which exercise affects cessation, and cessation in turn affects cardiovascular risk factors (e.g., BMI, lipids, depression) will be examined.

描述（由申请人提供）： 克服烟草使用和尼古丁依赖是主要的心血管风险因素之一，对女性来说似乎比男性更困难，主要是因为1）女性可能比男性对尼古丁的影响更敏感; 2）与持续吸烟相关的负面情绪在女性中比男性更常见; 3）女性更担心体重是继续吸烟和不试图戒烟的原因。运动干预与尼古丁替代疗法（NRT）相结合，应为女性吸烟者提供特别有效和具有成本效益的治疗。在我们正在进行的研究中，我们发现，在有监督的医院环境中进行有氧运动，并作为NRT的辅助治疗，比NRT的标准治疗产生了更高的戒烟率。然而，复发仍然非常迅速，坚持运动方案是不够理想的。在那些体重指数较高、尼古丁依赖程度较高和戒烟前抑郁的人中，运动坚持性特别差，即，心血管风险指数高的人。增加坚持锻炼可能会提高戒烟率，同时减少心血管危险因素，从而降低女性发病率和死亡率。这项拟议的研究将调查是否认知行为运动坚持咨询（CBC）添加到运动处方（ERx）中，在许多患者人群中有效使用，与ERx单独条件相比，增加试图戒烟的女性吸烟者参与体育锻炼。我们将研究是否增加运动坚持导致更高的戒烟率，以及是否规定的运动是以家庭为基础的（HB），使实施可能更容易和具有成本效益，将导致相同的戒烟效果作为一个运动计划，是以设施为基础的（FB）。我们计划将尼古丁透皮贴剂治疗作为药物治疗，有氧运动作为行为辅助治疗。这项拟议的研究将评估如何实现有氧运动对戒烟的最大效果，以及实现这些效果的最低条件。将对540名女性吸烟者进行经皮NRT给药，这些吸烟者被随机分配在以下四种条件之一下进行运动：HB+ERx、FB+ERx、HB+ERx+CBC或FB+ERx+CBC。参与者将从戒烟前3周至戒烟后12周每周进行3次有氧运动，并将在戒烟后随访一年。除了评估如何最好地实施有氧运动作为戒烟辅助手段外，运动影响戒烟的机制，以及戒烟反过来影响心血管风险因素（例如，BMI、血脂、抑郁症）。