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Trial record 2 of 311 for:    Recruiting, Not yet recruiting, Available Studies | Inhibition

Aerobic Exercise and Inhibitory Control (AMIAEIC)

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ClinicalTrials.gov Identifier: NCT03441737
Recruitment Status : Not yet recruiting
First Posted : February 21, 2018
Last Update Posted : February 21, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Harry Prapavessis, Western University, Canada

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Inhibition (Psychology) Behavioral: Exercise Behavioral: Non-Exercise Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Effects of Acute Aerobic Exercise on Inhibitory Control in Temporarily Abstinent Smokers
Estimated Study Start Date : April 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exercise
Aerobic exercise intervention
Behavioral: Exercise
20 minutes of aerobic exercise (walking on a treadmill) at 2/3 of participant's maximum heart rate (maximum heart rate calculated as 220-age).

Active Comparator: Non-Exercise
Non-aerobic exercise intervention
Behavioral: Non-Exercise
20 minutes of sitting in the laboratory with access to magazines and the internet.




Primary Outcome Measures :
  1. Inhibitory Control [ Time Frame: 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.


Secondary Outcome Measures :
  1. Urge to Smoke [ Time Frame: 24 hours post participant start date ]
    Questionnaire: 1 item from the Questionnaire of Smoking Urges (QSU) will be used to assess the urge to smoke.

  2. Time to First Cigarette [ Time Frame: 24 hours post participant start date ]
    The time to first cigarette post intervention will be calculated from time 0 being when the participant leaves the lab until the co-investigator receives a time-stamped message from the participant that they have light their first cigarette.



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03441737


Contacts
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Contact: Dr.Harry Prapavessis 519-661-2111 ext 80173 hprapave@uwo.ca
Contact: Anisa Morava, BSc 519-993-2866 amorava@uwo.ca

Sponsors and Collaborators
Western University, Canada
Investigators
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Principal Investigator: Dr.Harry Prapavessis Western University

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Responsible Party: Dr. Harry Prapavessis, Principal Investigator, Western University, Canada
ClinicalTrials.gov Identifier: NCT03441737     History of Changes
Other Study ID Numbers: 1795AM
First Posted: February 21, 2018    Key Record Dates
Last Update Posted: February 21, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Harry Prapavessis, Western University, Canada:
Aerobic exercise
Antisaccades
Urge to Smoke
Adults