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临床试验/NCT01635075
NCT01635075已完成2 期

Acute Effects of Exercise in Smokers With Schizophrenia

Brown University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2012年6月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
30
试验地点
2
主要终点
Cigarette craving

研究概览

简要总结

People with schizophrenia have two- to three-times the mortality risk of the general population. This is primarily due to their unusually high rates of cigarette smoking, as well as other cardiovascular risk factors such as physical inactivity, obesity, high blood cholesterol and diabetes. Effective smoking treatments are needed to reduce morbidity and mortality in this population. Over a dozen experimental studies indicate that walking and other forms of exercise acutely reduce cigarette craving, nicotine withdrawal symptoms and smoking behavior in non-psychiatric smokers. However, the effects of acute exercise on smoking measures have not been studied in smokers with schizophrenia. This study will use a within-subjects, repeated-measures design, in which participants will undergo 4 laboratory sessions (order counterbalanced across participants): (1) smoking cues followed by exercise, (2) smoking cues followed by passive activity, (3) neutral cues followed by exercise, (4) neutral cues followed by passive activity. Outcome measures include cigarette craving, nicotine withdrawal symptoms, mood and smoking behavior. If the results of this study indicate that walking acutely reduces craving and smoking in smokers with schizophrenia, the next step in this research would be to test the effectiveness of a smoking cessation intervention that incorporates exercise bouts as a behavioral strategy for improving smoking cessation rates in this population.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosis of schizophrenia
  • smoke at least 20 cigarettes per day
  • less than 60 min moderate-intensity exercise per week

排除标准

  • medication changes in past 4 weeks
  • unable to give informed consent to participate
  • alcohol/drug screen
  • pregnant or nursing
  • receiving or seeking immediate smoking treatment

结局指标

主要结局

Cigarette craving

时间窗: within 10 minutes before and after exercise (or control activity)

Questionnaire on Smoking Urges - Brief form

次要结局

  • Mood(within 10 minutes before and after exercise (or control activity))
  • Smoking habit withdrawal(within 10 minutes before and after exercise (or control activity))
  • Smoking choice(initiated 10 minutes after exercise (or control activity))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jennifer Tidey

Associate Professor (Research)

Brown University

研究点 (2)

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