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临床试验/NCT02086149
NCT02086149已完成不适用

Aerobic Exercise for Smokers With Depressive Symptomatology

Butler Hospital2 个研究点 分布在 1 个国家目标入组 231 人开始时间: 2014年2月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
231
试验地点
2
主要终点
Smoking Cessation

研究概览

简要总结

The purpose of this study is to test the effect of a moderate-intensity aerobic exercise intervention for helping individuals with elevated depressive symptoms to quit smoking. The investigators expect that this project will contribute much needed knowledge about the role that aerobic exercise can play in smoking cessation. The long-term goal of this program of research is to disseminate an effective, aerobic exercise (AE) intervention for smoking cessation that can be readily adopted by smokers with elevated depressive symptoms, including those with current major depressive disorder (MDD).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • are between 18 and 65 years of age
  • are current smokers (i.e., smoking at least 10 cigarettes per day)
  • have currently elevated depressive symptoms (CES-D ≥ 6)
  • are sedentary, i.e., have not participated regularly in aerobic exercise (for at least 90 minutes per week during the past three months)

排除标准

  • DSM-IV diagnosis of current mania
  • DSM-IV diagnosis of bipolar rapid cycling
  • lifetime history of psychotic disorder or DSM-IV diagnosis of current psychotic symptoms
  • DSM-IV diagnosis of current substance abuse or dependence in the past 6 months
  • DSM-IV diagnosis of anorexia or bulimia nervosa
  • current suicidality or homicidality
  • marked organic impairment
  • current use of antidepressant medication for less than 3 months or change in antidepressant medication or dosage in the past 3 months,
  • physical disabilities or medical problems that would prevent or hinder participation in a program of moderate intensity exercise (i.e., physician denied medical clearance)
  • current pregnancy or intent to become pregnant during the next 12 weeks
  • contraindications for use of the nicotine patch (e.g., pregnancy, recent myocardial infarction, arrhythmia, angina, untreated hypertension, untreated diabetes, and previous adverse reaction to the patch)
  • current illness or medications that may alter proposed inflammatory markers (e.g., acute infection, immune disorders, aspirin)
  • current use of any pharmacotherapy or other treatment for smoking cessation.

研究组 & 干预措施

Exercise

Experimental

12-week moderate-intensity behavioral exercise intervention (AE)

干预措施: Aerobic Exercise (Behavioral)

Health Education

Active Comparator

12-week health education control

干预措施: Health Education (Behavioral)

结局指标

主要结局

Smoking Cessation

时间窗: 1 year

Abstinence from smoking verified biochemically (saliva cotinine)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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