Aerobic Exercise and Inhibitory Control (AMIAEIC)

February 29, 2024 updated by: Dr. Harry Prapavessis, Western University, Canada

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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:

  • Smoking abstinence period: The participant will be instructed at the end of Phase I that they will have to complete a 12 hour smoking abstinence period (refraining from smoking cigarettes or consumption of any tobacco products) at home before coming back into the lab. The participant will be also notified that the co-investigator will be able to assess whether they completed this abstinence period through assessing the carbon monoxide reading on the Smokelyzer.
  • Biological confirmation of carbon monoxide reading: Participant will briefly blow air into a Smokelyzer (device which assess how much carbon monoxide in parts per million is present in the breath of a smoker). The participant will have to blow below 10 parts per million carbon monoxide to have successfully abstained and thus participate in Phase II.

  • Questionnaire: Participant will be asked to fill out to the best of their ability the following questionnaire:

    f. Urge to Smoke ("I have an urge for a cigarette")

  • Cognitive Computer Task: Participant will complete the same Antisaccade Task as outlined in Phase I.
  • Intervention Participant will be randomly assigned (through a randomly generated number sequence) to either 20 minutes of aerobic exercise or 20 minutes of sitting.
  • Aerobic Exercise Intervention: The participant will complete a 20 minute walking exercise on a treadmill.
  • Non Exercise: The participant will be in a seated position in the lab waiting room. They will be provided with magazines and computer access.
  • Post Intervention:

  • Questionnaire: Participant will be asked to fill out to the best of their ability the following questionnaire:

    f. Urge to Smoke ("I have an urge for a cigarette")

The participant will then be told to notify the co-investigator of when they light their next cigarette through a time-stamped email or text message. The time in minutes from when they leave the lab (time: 0) until the message is received will be calculated.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Dr.Harry Prapavessis
  • Phone Number: 80173 519-661-2111
  • Email: hprapave@uwo.ca

Study Contact Backup

  • Name: Anisa Morava, BSc
  • Phone Number: 519-993-2866
  • Email: amorava@uwo.ca

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
24 hours post participant start date

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
24 hours post participant start date
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.
24 hours post participant start date

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Western University, Canada

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dr.Harry Prapavessis, Western University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2018

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 9, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 22, 2018

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 4, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 29, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1795AM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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