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临床试验/NCT03441737
NCT03441737撤回不适用

The Effects of Acute Aerobic Exercise on Inhibitory Control in Temporarily Abstinent Smokers

Western University, Canada0 个研究点开始时间: 2018年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
主要终点
Inhibitory Control

研究概览

简要总结

Although more than half of Canadian smokers in 2015 attempted to quit, with one-third attempting more than once, successful smoking cessation (quitting) remains a challenge. Relapse (return to smoking) has been attributed to failures in inhibitory control. Inhibitory control is the ability to suppress actions. Previous studies have identified that aerobic exercise improves inhibitory control and reduces the urge to smoke. This study will examine whether an acute bout of moderate intensity aerobic exercise (i.e. brisk walk on a treadmill) will improve inhibitory control, increase time to first cigarette smoked, and reduce urges to smoke during a brief period of abstinence. Inhibitory control will be assessed using the antisaccade task, which requires the participant to shift their gaze away from a visual target presented to them. Phase I will include assessments of smoking behaviours, physical activity levels, urges to smoke, and inhibitory control. Phase II will consist of a 12-hour smoking abstinence period conducted at home, followed by reassessment of urges to smoke and inhibitory control. Participants will then be randomized to either 20 minutes of aerobic exercise or sitting. Following the intervention, reassessment of urges to smoke, inhibitory control, and time to first cigarette smoked will be conducted.

详细描述

The participant will be provided a letter of information and an informed consent form. Once they have signed the informed consent form, the following procedures will take place:

Phase I:

  • Initial biological confirmation of carbon monoxide reading: Participant will briefly blow air into a Smokelyzer (device which assesses how much carbon monoxide in parts per million is present in the breath of a smoker)
  • Baseline questionnaires: Participant will be asked to fill out to the best of their ability the following questionnaires:
  1. Demographic questionnaire (Asks you identifiable information concerning, your age, email telephone number)
  2. Smoking history questionnaire ("What is the approximate date and time of the last cigarette you have smoked?")
  3. Fagerstrom Test for Nicotine Dependence ("How many cigarettes do you smoke each day?")
  4. Godin Leisure-Time Exercise Questionnaire ("In the last 7 days, how many times have you completed mild intensity exercise for 15 minutes or more?")
  5. Physical Activity Readiness Questionnaire ("Do you feel pain in your chest at rest?")
  6. Urge to Smoke ("I have an urge for a cigarette")
  7. Heart rate will be measured with a heart rate monitor. Blood pressure will be measured with an electronic blood pressure cuff.
  • Cognitive computer task: Participant will be asked to complete a computer task which assesses inhibitory control (the cognitive ability to suppress responses to stimuli). The Antisaccade Task will be used to assess inhibitory control in this study.

Phase II:

研究设计

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

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 18-64 years of age
  • Smoke at least 10 cigarettes per day (or more) for at least 6 months
  • Able to perform a twenty-minute exercise task at a moderate intensity (2/3 of participant's maximum heart rate) without health implications
  • Can read and write in English
  • Have email or phone number for contacting purposes

排除标准

  • Do not have Chronic Obstructive Pulmonary Disease
  • Do not have a medical condition that prevents you from exercise (e.g. heart attack in the past year, heart disease, irregular heartbeat, etc.)
  • Do not have history of eye injury or neurological impairment
  • Do not have an orthopaedic limitation
  • Are not pregnant

结局指标

主要结局

Inhibitory Control

时间窗: 24 hours post participant start date

Cognitive computer task: Participant will be asked to complete a computer task which assesses inhibitory control (the cognitive ability to suppress responses to stimuli). The Antisaccade Task will be used to assess inhibitory control in this study. A saccade is a rapid eye movement towards a visual target. An antisaccade is a rapid eye movement away from a visual target. The ability to suppress making an eye movement towards a visual target gauges inhibitory control. The participant will be seated in a chair facing a computer screen in which visual stimuli (a cross) will appear. The participant will be fitted into a chin rest and a monocle will be adjusted so that images of eye movements can be assessed. A training phase will take place at the beginning of the task to familiarize the participant with the instructions. The participant will make a series of saccades and antisaccades. The reaction times and directional errors to the visual stimuli will be recorded.

次要结局

  • Urge to Smoke(24 hours post participant start date)
  • Time to First Cigarette(24 hours post participant start date)

研究者

发起方
Western University, Canada
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Harry Prapavessis

Principal Investigator

Western University, Canada

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