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临床试验/NCT01423578
NCT01423578已完成不适用

Effects of Yoga and Cardiovascular Exercise on Smoking Motivation

H. Lee Moffitt Cancer Center and Research Institute1 个研究点 分布在 1 个国家目标入组 79 人开始时间: 2007年8月21日最近更新:
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
79
试验地点
1
主要终点
The Number of Participants Reporting Post Intervention Effects

研究概览

简要总结

The overall purpose of this pilot study is to examine effects of Hatha yoga and cardiovascular exercise on craving, mood, cue reactivity, and smoking behavior. Our preliminary study indicated that a single session of either form of activity intervention improved mood, and the yoga intervention appeared to decrease cravings to smoke. The proposed study will extend this preliminary research in several ways.

详细描述

First, the investigators will expand the exercise-based interventions from one to three sessions, which will more closely resemble how these interventions may be used in the context of smoking cessation. Second, the investigators will recruit smokers who are motivated to quit smoking, further increasing the clinical relevance of the research. Finally, the investigators will examine the effects of the interventions on actual smoking behavior within and outside of the laboratory setting. This may appropriately be considered a "proof of concept" study, as the investigators will not be powered to detect treatment outcome (smoking cessation) differences, nor are the interventions designed to maximize clinical smoking cessation outcomes.

Participants will be randomized to receive 3-sessions of yoga instruction, 3-sessions of cardiovascular exercise, or to a no activity control group. Sessions will be scheduled to occur approximately 7 days apart, with a minimum of 4 between sessions. Mood and craving will be assessed before and after each session, and smoking behavior will be assessed following each session. Finally, a detailed cue reactivity assessment will be conducted prior to the first session and following the last session. Analyses will examine intervention effects on craving, mood, cue reactivity, and smoking behavior. In addition, the investigators will examine several potential mediators and moderators of intervention effects on smoking behavior. Finally, the investigators will continue to examine the feasibility and potential acceptability of each active intervention, to assist in developing future clinical applications of these techniques in the context of smoking cessation.

研究设计

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

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Smoke at least 10 cigarettes per day
  • •Smoked regularly at least 2 years
  • •Carbon monoxide reading at least 8 ppm
  • •Interest in quitting smoking
  • •Able to read and understand the consent form and questionnaires
  • •Not currently practicing yoga

排除标准

  • •Current Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) (American Psychiatric Association, 1994) psychosis
  • •Major depressive episode, manic episode, or panic disorder
  • •Current DSM-IV psychoactive substance dependence or use
  • •Current medication use that might affect physiological responses
  • •Current use of bupropion, varenicline, or nicotine-containing products other than cigarettes
  • •Significant health problems that might compromise physiological data collection or be contraindicated for moderate physical exercise or yoga
  • •Significant hearing or visual impairment; pregnant as determined by urine human chorionic gonadotropin (hCG) test or nursing females
  • •Body mass index (BMI) 35 or greater

研究组 & 干预措施

Hatha Yoga (HY)

Active Comparator

Exercise and Smoking Cessation Counseling

干预措施: Hatha Yoga (HY) (Behavioral)

Hatha Yoga (HY)

Active Comparator

Exercise and Smoking Cessation Counseling

干预措施: Smoking Cessation Counseling (Behavioral)

Cardiovascular Exercise (CE)

Experimental

Exercise and Smoking Cessation Counseling

干预措施: Cardiovascular Exercise (CE) (Behavioral)

Cardiovascular Exercise (CE)

Experimental

Exercise and Smoking Cessation Counseling

干预措施: Smoking Cessation Counseling (Behavioral)

Smoking Cessation Counseling Only

Other

Control Group - Smoking Cessation Counseling

干预措施: Smoking Cessation Counseling (Behavioral)

结局指标

主要结局

The Number of Participants Reporting Post Intervention Effects

时间窗: Average of 6 Months

Intervention effects on measures of craving, mood, cue reactivity, and smoking behavior will be analyzed with mixed-design analysis of variance (ANOVA), with Intervention as the between-group factor (HY vs. CE vs. NA), and Time as a within-subject factor (pre vs. post-intervention). Analyses for cue reactivity variables will include the additional within-subject factor of Cue Type (smoking vs. neutral), and analyses for craving and mood self-report will include the additional within-subject factor of Session (1 vs. 2 vs. 3).

次要结局

  • Number of Participants Reporting Behavior Changes Post Intervention(Average of 6 Months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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